chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Acute onset of myalgia, polyarthraglia, cramps, weakness, stiffness, fatigue, edema, decrease mobility of small joints of hands, feet, wrists and ankles.  Difficult to write and grasp items starting a few days after the first dose.  Symptoms increased after second dose and continue to persist.
Approximately 48 hours after my second Covid vaccine, I spiked a fever of 101.5 and had extreme kidney pain. Frequent urge to urinate. I ended up going into the doctor to have a urine test checking for a bladder infection. Blood was found in my urine. My doctor put me on an antibiotic. I have not had a bladder infection in over 20 years and  I have never had kidney pain.
Severe body aches, temp of 102, h/a, heart arrythmia, severe shaking chills; episodes repeated every 4-6 wks for 14 months with symptoms less severe and episode shorter; no episodes for 6 months then another severe one on 11/5/11.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, drug reactions or allergies, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M031557, expiry date 07-APR-2019; lot # L040054, expiry date 26-DEC-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 27 degrees Fahrenheit for 1 hour and 20 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information is not expected as there was no consent to contact physician.; Sender's Comments: US-009507513-1703USA007944:
Lightheaded and feeling faint 5 minutes post vaccination  BP 96/65, 101/65, 115/81 O2 sat 95% HR - 92
first Shingrix on 9/29/2021, second 11/24/2021; injection site was sore; Headache; fever; body aches; Chills; tiredness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 50-year-old male patient who received Herpes zoster (Shingrix) (batch number 2LH9L, expiry date 4th October 2022) for prophylaxis.   Co-suspect products included COVID-19 VACCINE for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 24th November 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml and COVID-19 VACCINE. In November 2021, 24 hrs after receiving Shingrix and an unknown time after receiving SHINGRIX, the patient experienced headache, fever, general body pain, chills and tiredness. On 24th November 2021, the patient experienced injection site pain and drug dose administration interval too short. On an unknown date, the outcome of the injection site pain, headache, fever, general body pain, chills and tiredness were recovered/resolved and the outcome of the drug dose administration interval too short was unknown.   The reporter considered the injection site pain to be related to Shingrix. It was unknown if the reporter considered the headache, fever, general body pain, chills and tiredness to be related to Shingrix.  Additional details were provided as follows: The reporter was patient and employee. The age at vaccination was not reported. The patient got his first Shingrix vaccine on 29th September 2021, 0.5 ml intramuscular in left arm. The patient received his second shingrix vaccine and Covid booster on the same day. He got his shingrix vaccine in his left arm and his covid booster in his right arm.  The reporter advised to tell patients not to get the shingrix vaccine and Covid booster on the same day. The reporter stated that immediately after getting the Shingrix vaccine, the injection site was sore and lasted 24 hours.  About 24 hours post getting his shingrix and covid vaccine, the patient developed a headache, fever, body aches, chills, and tiredness. The symptoms lasted for about 48 hours. All the symptoms had resolved. The patient received 2nd dose 5 days short of 2 months which led to shortening of vaccination schedule. The patient received all of his vaccines at his local pharmacy. The patient was unsure if his symptoms were related to the shingrix vaccine, covid booster, or a combination of both.  The reporter consented to follow up.
Entire (L) upper arm red/ swollen/ tender from deltoid to elbow - warm to touch, painful to move. Will Tx w/ oral KEFLEX an topical steroid.
pt c/o aches, pains, chills & redness & soreness @ inj site;no fever;pt told to cont vicodin for pain, also take advil plenty of fluids;pt advised to f;u w/OHC-no work x 2 days
resident had mental status change, low oxygen, back pain.  Sent to hospital for evaluation.  Identified as positive covid.
Chills on body on and off after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills on body on and off after vaccination) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills on body on and off after vaccination). At the time of the report, CHILLS (Chills on body on and off after vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant products were reported.  No treatment drugs were reported   Reporter did not allow further contact
Redness appeared a week after vaccination after check ins completed, itchy and red.  Apparently a common issue, wanted to self report my "COVID arm"
had a rash under my arms (It is extremely itchy); This case was reported by a consumer via interactive digital media and described the occurrence of itchy rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced itchy rash. On an unknown date, the outcome of the itchy rash was recovered/resolved.   It was unknown if the reporter considered the itchy rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. The patient received the 1st dose of Shingrix and patient experienced rash under arms and was extremely itchy. The reporter stated that rash was not going away.
Pt received IPV on 5/21/02. On the eve of 5/22/02, mother noticed a rash on arms and legs (urticarial in nature) and maculopapular rash on back. Rash was still present on 5/23/02. Pt brought to clinic on 5/24/02 with resolution of urticaria. Noticeable macularpapular rash on the back and sporadic on extremities. Suggested Benadryl if it returned. No viral symptoms or fever.
Initial report received from a health care professional on 10 Sep 2010: This patient was vaccinated with only the MenCWY liquid conjugate component of MENVEO (batch number: 100022). No other information provided at the time of this report.
Information has been received from a registered pharmacist concerning three female patients who on unknown dates were vaccinated with GARDASIL, lot # not reported. The pharmacist stated that she heard of three patients who experienced immediately "electric feeling" pain at injection site when GARDASIL vaccine was administered. The pain extended down to the finger tips from the injection site of upper arm. The pain resolved without treatment within a few hours but the "arm felt weak for a couple of days". All three patients recovered fully. Additional information is not expected.
Pt later developed probing headache and increased difficulty breathing. This prompted pt to be taken to urgent care later that day.
rash on arm/hands/chest; This case was reported by a consumer via call center representative and described the occurrence of rash in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th July 2020, the patient received Shingrix. On 31st July 2020, 2 days after receiving Shingrix, the patient experienced rash. On 2nd August 2020, the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had rash on her chest, arm and hands which resolved in 2 days. The reporter consented to follow up.
Joint paint, low-grade fever, chills that lasted 1-2 hours, fatigue, severe arm pain that lasted for several hours.
This spontaneous report was received from a licensed practical nurse and refers to a 12 month 8 day, old female patient. The patient had esotropia on the left eye and a small hemangioma over right eye. Upon general examination, the patient was found to be pleasant, alert and orientated, in no apparent distress, well developed and well nourished. The patient had no known drug allergies. The patient had had no intercurrent illness recently. On an unspecified date, between 29-AUG-2015 and 29-OCT-2015, the patient was vaccinated with improperly stored dose (incorrect product storage) of (Merck) VARIVAX 0.5 ml, lot number L008273, on the left vastus lateralis. Patient was concomitantly vaccinated with PREVNAR 13, M-M-R II and HAVRIX. The outcome of the incorrect product storage was not known. There were no adverse effects. This is one of several reports received from the same source. Additional information has been requested.
5 hours after injection had to lay down 3 times or pass out, diarrhea, throw up total body sore, stomach ache to 3 days.
FEVER OFF AND ON; TIRED; LABORED BREATHING; This spontaneous report received from a patient concerned a 60 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072, expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 on left deltoid for prophylactic vaccination. No concomitant medications were reported. On 23-MAR-2021, the subject experienced labored breathing. On 01-APR-2021, the subject experienced tired. On 03-APR-2021, the subject experienced fever off and on. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tired, and fever off and on, and the outcome of labored breathing was not reported. This report was non-serious.
ON 1/1/21 AT 1PM, DEVELOPED A SEVERE MIGRAINE WITH ON/OFF NAUSEA AND DIARRHEA. LASTED 14 HOURS BEFORE RESOLVING
Headache, achiness, redness and pain to affected arm at vaccine site, general malaise.
Prior to second dose she needs to take antibiotics for tooth infection and tooth extraction; taking antibiotic if affect second dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 27Feb2021 (Lot number: EN6198) 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: TOOTH INFECTION (non-serious), outcome "unknown", described as "Prior to second dose she needs to take antibiotics for tooth infection and tooth extraction; taking antibiotic if affect second dose".  No follow-up attempts are possible. No further information is expected.
left arm itches where the injection took place. No redness, soreness for over a week, but itchy.
Pt called stating arm hurting very swollen & hot to the touch. Swelling was half way down right arm.
had a seizure; passed out; This is a spontaneous report from contactable nurse via Pfizer Sales Representative.   A 17-year-old male patient received the 1st dose of meningococcal group b rlp2086 (TRUMENBA) at single dose, and meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA), both on an unspecified date for immunization.  The patient medical history and concomitant medications were not reported.  The patient passed out and had a seizure on an unspecified date within minutes of receiving vaccines. The Patient recovered within a minute and was quickly aware of surroundings.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a contributory role of TRUMENBA towards the occurrence of events passed out and seizure cannot be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
tested positive for COVID-19 the first time on 16Apr2022; tested positive for COVID-19 the first time on 16Apr2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Feb2021 at 12:00 as dose 1, single (Batch/Lot number: unknown), in right arm, on 11Mar2021 at 12:00 as dose 2, single (Lot number: EN6201), in right arm and on 06Oct2021 at 12:00 as dose 3 (booster), single (Lot number: EN6204 301308A) at the age of 62 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LEXAPRO. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 16Apr2022, outcome "unknown" and all described as "tested positive for COVID-19 the first time on 16Apr2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Apr2022) Positive; (unspecified date) Unknown results, notes: no results back yet; (26Apr2022) Negative, notes: Took a rapid test and tested negative to it 10 days later"; (11May2022) Positive, notes: I wanted to go out yesterday; (12May2022) Positive, notes: I tested again today this morning. Therapeutic measures were taken as a result of covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Got very week; Not feeling great; Pain on joints; Fever; Chills; Couldn't get out of bed; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Got very week), FEELING ABNORMAL (Not feeling great), ARTHRALGIA (Pain on joints), PYREXIA (Fever) and CHILLS (Chills) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in March 2020.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced ASTHENIA (Got very week), FEELING ABNORMAL (Not feeling great), ARTHRALGIA (Pain on joints), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Couldn't get out of bed). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 31-Jan-2021, FATIGUE (Couldn't get out of bed) had resolved. At the time of the report, ASTHENIA (Got very week), FEELING ABNORMAL (Not feeling great), ARTHRALGIA (Pain on joints), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.            No concomitant medication reported   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Contact information updated, second dose details updated and no AE reported for 2nd dose
Patient received the covid vaccine on 12/22/2020.  No problem with the vaccination. Reported new onset of "dry cough" and nasal congestion started on 12/29/2020.  Denies fever, chills, HA, body aches, or fatigue.  Last covid test on 12/17/2020 was negative.
Swelling of lips and tongue.  Itching of throat. Benadryl q 4 hours for 24 hours Side effects subsided after 48 hours
Pressure behind eyes - 7 days Headache - 7 days Stye in eye - 4 days swollen lymph nodes, neck - 2 weeks "necklace" rash - 3 inches around - around neck - 2 weeks hives from neck to ankles - 4 weeks soreness at injection site - 1 day  Took NSAID (Advil)
Slight bloody show as if starting my monthly period. I have not had a period in over 8 years.
Patient was given first series of Moderna while under the age of 18. Patient was 17 during administration of vaccine. No adverse reactions noted.
Approximately 12 hours after receiving the injection, I woke up with moderately severe pain at the injection site (no redness or swelling), severe chills, all-over body aches, cramps in calves, hamstring muscles and left foot arch, and fever (did not have working thermometer so unable to report degree, but head, face and body very hot). I did not take any medication because this was the first adverse reaction to a vaccination I've ever had and was not sure what would be best or wrong to take. The symptoms continued until about 9:00am at which time they seemed to subside a bit. I continued to have body aches and weakness all over, but fever, chills and cramps had stopped. I spent the day resting and felt much better around 6:00pm, though weakness continued until the next morning (today). I now feel back to normal with only minor soreness at the injection site. I have not reported this to my doctor or to the injection provider.
someone is with exposure but the last tested negative for 10 days then she can be on track for the vaccine tomorrow; This is a spontaneous report from a contactable other hcp.   contactable consumer reported that A patient of unspecified age and gender received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as an unspecified dose for an unspecified indication. The patient's medical history and  concomitant medications were not reported. Caller stated that , One of her caregivers, last saw her mom on 25Jan2021 where she tested negative for covid and has been symptom free.  She got her vaccine on 13Jan2021 and is due tomorrow for her 2nd dose. At the facility the coordinators mentioned if someone is with exposure but the last tested negative for 10 days then she can be on track for the vaccine tomorrow. Tomorrow will be day 10. She remained asymptomatic, can she enquired if she can get her 2nd dose?. The patient experienced someone is with exposure but the last tested negative for 10 days then she can be on track for the vaccine tomorrow (exposure to sars-cov-2) (non-serious) on an unspecified date with outcome of unknown.  Information on Lot/ Batch number has been requested.
Pt received vaccines ~ 1230 pm. Pt. tolerated well. Received Tdap, MMR,  Varicella, and ppd. Asked pt. if I could procede with obtaining blood  at which point he nodded yes. Pt. was in sitting position-Began drawing lab specimen on patient which included 2 tiger tops and 1 lavender container. Lab test to be obtained  Hep A,B,C, HIV, RPR. At ~1240 when last tube was obtained noticed patient body core, lower and upper extremities tensed up, fists clenched and became very rigid. Whole body then shook for ~8 seconds- after this patient face became a bluish color and jaw tightened. This lasted about 6 seconds. Turned on fan in lab and tapped Pt. on face. I placed patient on the floor from sitting position and placed him in recovery position on the floor of the lab. Pt. was unable to follow or respond to verbal commands for ~2-3 minutes. EMS initiated at ~1241 by LVN. BP obtained when patient was in recovery position = 90/50, P= 60, RBS = 101 mg/dl. Pt. spoke to interpreter on phone. Denied previous history of seizure or seizure like activity. Pt. evaluated by FNP. Please see Referral form to ER completed by FNP. Pt. sent to Hospital via EMS for evaluation and treatment. A&O x 3 at discharge.
I felt fine after the vaccination at 11AM. Between 1-3:30PM, I got a pedicure and  drank two 5.4% alcohol beverages. I drove home, made dinner, and ate. Shortly after eating, around 7:00PM, the soreness in my arm got intense, I began feeling nauseous and disoriented. I went to the bathroom and got on my hands and knees because I thought I was going to vomit. My boyfriend helped me get up on the edge of the bathtub, but I quickly passed out and fell forward. He said I was out for approximately 30 seconds. I came to long enough to tell him to call my mom then passed out again. for about 15 seconds Within minutes my mom, sister and daughter arrived, followed by first responders. First responders had to keep me from passing out for about 10 minutes, during which time I broke into a cold, soaking sweat, had involuntary muscle convulsions, extreme nausea, disorientation, slurred speech, and loss of ability to get up or walk on my own. I was admitted to the emergency room around 7:45. It took another hour for me to regain muscle control, speech and total coherency. I was released and went home. My arm was severely sore until Monday morning, but I also experienced severe fatigue, nausea, headache and muscle aches until late Sunday.
LEFT AXILA PAIN/DISCOMFORT - PATIENT BELIEVES TO BE LYMPH NODE, IT HAS BEEN SINCE VACCINATION ONLY ON SIDE OF SHOT
Began to experience dizziness, chest tightness, throat irritation, difficulty breathing, difficulty swallowing.  Administered 1 epi-pen injection on the way to the ER. Once at the ER, I was given IV antihistamine and steroids. After discharge from ER, I was prescribed famotidine and prednisone.
Dizziness; This is a spontaneous report received from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202), via an unspecified route of administration in left arm on 04Mar2021 (at the age of 61-years-old), as a single dose for COVID-19 immunisation. Medical history included thyroid removal. The patient was allergic to shingles vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included hormones (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN), magnesium (MANUFACTURER UNKNOWN), melatonin (MANUFACTURER UNKNOWN) and vitamin (MANUFACTURER UNKNOWN) all for unknown indication from unknown dates. The patient did not receive any other vaccines within 4 weeks prior to the COVID -19 vaccination. Since the vaccination, the patient was tested for COVID-19.  On 06Mar2021, the patient experienced dizziness which started two days later had not resolved. On 17Mar2021, the patient underwent nasal swab test for COVID-19 and the result was negative. The event dizziness is resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the event dizziness. The clinical outcome of event dizziness was not resolved.    No follow-up attempts are needed. No further information is expected.