chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PALPITATIONS; RIGHT CALF CRAMPS; DYSGEUSIA; TINNITUS; DIARRHEA; DIZZINESS; CHILLS; FEVER; FATIGUE; NAUSEA; This spontaneous report received from a patient concerned a 59 year old female. The patient's weight was 225 pounds, and height was 62 inches. The patient's concurrent conditions included chronic kidney disease, meniere's disease, anxiety, occasional drinker, non smoker, allergic to keflex, and environmental allergies, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. the patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 13-APR-2021 for prophylactic vaccination. Concomitant medications included lisinopril for chronic kidney disease, and spironolactone for chronic kidney disease. On 13-APR-2021, the subject experienced fatigue. On 13-APR-2021, the subject experienced nausea. On 14-APR-2021, the subject experienced tinnitus. On 14-APR-2021, the subject experienced diarrhea. On 14-APR-2021, the subject experienced dizziness. On 14-APR-2021, the subject experienced chills. On 14-APR-2021, the subject experienced fever. On 15-APR-2021, the subject experienced dysgeusia. On 03-MAY-2021, the subject experienced palpitations. On 03-MAY-2021, the subject experienced right calf cramps. On 05-MAY-2021, Laboratory data included: Doppler scan (NR: not provided) Negative, and Electrocardiogram (NR: not provided) Normal. On 07-MAY-2021, Laboratory data included: Blood test (NR: not provided) Unknown, and Urinalysis (NR: not provided) Unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dysgeusia on 24-APR-2021, diarrhea on 14-APR-2021, right calf cramps on 04-MAY-2021, chills, and fever on 15-APR-2021, and nausea on 16-APR-2021, and was recovering from dizziness, tinnitus, palpitations, and fatigue. This report was non-serious.
roughly 2 weeks after his immunizations he became, fatigued, weak, and unsteady; he kept falling.  I finally took him to a neurologist, and an MRI was reformed; result found were: MS,Demyelinating Encephalopathy,Post Vaccination Reaction,  also diagnoised with Hypotonia, gait disturbance/Ataxia.In PT and OT at Easter Seals. Suffers also from: asthma, allergies, AD, fatigue and weakness. In continious treatment now. The medical record states congenital atonia, attention deficit disorder, and R frontal venous angioma.
Spontaneous hives all over the body, but mostly from the hips and up, that lasted over a week until I took Claritin for 2 days straight and then it went away.
This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 71-year-old female patient who received FLUARIX QUADRIVALENT (batch number 32NZ7, expiry date 30th June 2016). Concomitant products included PREVNAR. On 19th October 2015, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. On an unknown date, less than a week after receiving FLUARIX QUADRIVALENT, the patient experienced extensive swelling of vaccinated limb, inflammation localized and pain in arm. On an unknown date, the outcome of the extensive swelling of vaccinated limb, inflammation localized and pain in arm were unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb, inflammation localized and pain in arm to be related to FLUARIX QUADRIVALENT. Additional details were received as follows: The patient received FLUARIX QUADRIVALENT in right deltoid. In October 2015, less than a week after receiving FLUARIX QUADRIVALENT, the patient experienced inflammation, swelling at elbow and swelling up and down the arm, increased swelling and pain. The reporter did not want to provide further details and stated that someone should contact the patient to obtain further information.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Visual Changes/Disturbances-Severe, Additional Details: ems came, evaluated pt. pt refused ambulance and signed a waiver. walked out with his mother on his own accord
Sore throat; Starting to lose voice; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat) and DYSPHONIA (Starting to lose voice) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Sore throat) and DYSPHONIA (Starting to lose voice). At the time of the report, OROPHARYNGEAL PAIN (Sore throat) and DYSPHONIA (Starting to lose voice) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was reported
Extreme debilitating joint pain with occasional relief with ibuprofen. Non stop pain since 2nd vaccine.  Inflammation and joint pain localized mostly in joints with previous injuries and nerve pain in feet. Right knee, left shoulder, both feet and both ankles. Nerve pain- sensation of burning, feeling like fire.
Caller got a 3rd booster today 14Jul2022 of Moderna.; This spontaneous case was reported by a patient and describes the occurrence of EXTRA DOSE ADMINISTERED (Caller got a 3rd booster today 14Jul2022 of Moderna.) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0171322A and 016J212A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (Dose 1), Pfizer (1st booster dose) and Pfizer (Dose 2). Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer and Pfizer. Concurrent medical conditions included Immunocompromised.   On 13-Feb-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2022, received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jul-2022, the patient experienced EXTRA DOSE ADMINISTERED (Caller got a 3rd booster today 14Jul2022 of Moderna.). At the time of the report, EXTRA DOSE ADMINISTERED (Caller got a 3rd booster today 14Jul2022 of Moderna.) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
Pt cried non-stop for over 6 hrs unresolved w/APAP-food etc; mom said "screaming on & on & on 1PM, PM & night; cried even next day for several hrs;
Stomach upset; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "Stomach upset".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
REDDISH RASH ON CHEST AREA. RASH DOSE NOT ITCH. 18 JUN 08 RASH APPEARED. NO OTHER AREAS OF THE BODY HAVE RASH.
Bell's Palsy. Feel numbness on the right side of face for about 10 days.
Within 5 minutes of vaccine started to feel tongue tingling. Within 20 minutes felt cotton mouth, tongue and lips tingling and voice was raspy, slight chest tightness. Benadryl 50mg given and sent to the ED for further follow up.
9cm erythema at injection site on Right leg. Child not bothered by this; no pain or itching.   Cleared in couple of days per parent
Chest tightness, mild diff breathing. EMS administered albuterol. Pt felt relief. Pt alert and conversing properly.
Fever 104 and vomiting- symptomatic Tx, improving on day 2 with fever down to 99.
Fever, chills, muscle ache, headache, swelling/pain at injection site. Onset about 16 hours after shot. Symptoms still present.
pt recvd vax & exp pruritic rash; pt was dx w/scabies; pt was treated w/Elimite 5% cream; 19JAN93 reporting MD indicated the events had almsot resolved; pt recvd 2 addtl doses of Engerix-B;
Two days after second shot Patient experienced: tingling/numbness in both hands; A rash to his face,chin and to both arms; Itching with bumps, swollen fingers and toes; Rash and swelling moves around body with elevated  joint/bone pain; fevers on/off. 2/13/21- Went to Urgent Care, given Keflex with no change.2/15/21- Urgent Care second visit, Keflex stopped.2/17/21- Clinic, Benadryl & Tylenol PRN and labs done with no change in rash, Covid test negative. 2/18/21- Dermatology Appointment- Doxycycline 100mg BID, Hydroxyzine PRN, Zyrtec OT, Punchbx left ankle. 3/11/21 - No diagnosis made in Hospital or from follow-up visit with Dermatologist. Continue to have occasional area of transient redness and some numbness and tingling in hands.
Chills, body ache, fatigue 100.9 fever-lasted 24 hrs Injection site very sore + approximately 48hrs after injection soreness mored toward armpit. Arm is warm, red, itches slightly almost entire upper arm (5" long x 2" wide) + still tender to touch on 12-21-20
08/17/04 Phone call from mom complaining of redness/pain at injection site. 8/17/04 Phone call complaining of increased redness/swelling. Appointment 8/18/04 Redness from below elbow extending above shoulder; arm swollen/hot to touch. Rx Augmentin 400mg BID for 10 days. Right arm involved.
Breakthrough case admission after 2 vaccines pfizer 7/23/21 Lot# Ew0173;  Pfizer 8/13/21 Lot# Ew0173
This spontaneous report as received from a other health professional refers to unspecified number of patients of unkonwn age. It was reported that the GARADASIL of unknown dose, have undergone a second temperature excursion date 2-JUL-2014 and have been administered post initial excursion reported as 16-JAN-2014. Excursion supported. It was reported that no adverse events and no concerns are reported by any patients. GARDASIL have been administered since date of last excursion of 27-JAN-2014 is with Lot number J012212 and expiry date 18-FEB-2016. This is one of the several reports from the same source: different patients same reporter. Additional information has been requested.
This report describes the occurrence of pityriasis lichenoides et varioliformis acuta in a 12 y.o. female who received Hep B vaccine recombinant (Engerix-B). This report was received from the subject's mother and has been confirmed by a dermatologist. The subject's medical history, concurrent conditions, and concomitant medications were not provided. The subject experienced no adverse events following receipt of her first injection of Engerix-B. On 1/8/02, the subject received her 2nd injection of Engerix-B. On 1/10/02, 2 days post immunization, she developed a blotchy rash all over her body. On that date, the subject presented to her primary care physician and again on 1/15/02 for the body rash. Initially the rash was thought to be scabies; however, it did not respond to treatment. The subject was subsequently treated for eczema; however, the rash did not improve significantly with steroid cream (NOS). The subject's mother stated that the rash "did seem to get better for a period of time, but would keep breaking out again in a rash off and and on since January on her legs and arms the most." Subsequently, the subject was referred to a dermatologist. The subject presented to the dermatologist on 1/29/02, with a 2 to 3 week-old itchy rash on her trunk and extremities. Initially the subject was suspected of having scabies or contact dermatitis and was treated with permethrin (Elkimite) and fluocinonide topically; however, there was no relief. Additionally, the dermatologist suspected possible pityriasis lichenoides et varioliformis acuta (PLVA), therefore; fluticasone propionate (Cutavate) was prescribed. On 2/7/02, the subject's mother called to report that the eruption had worsened. Upon the subject's return visit on 2/15/02, the dermatologist noted that the rash was spreading further and a diagnosis of pityriasis lichenoides et varioliformia acuta (PLVA) was confirmed. The dermatologist advised the subject to continue treatment with Cutivate as he did see some benefit from using the cream. Additional treatment included erythromycin 200 mg 3 times daily by mouth. On 6/10/02, the subject's mother called to report that her daughter did not get new lesions; however, complained of increased pigmentation from old lesions. The subject was treated with hydroquinone (Alustra) cream to be used twice daily topically. According to the dermatologist, the blotchy rash resolved with sequela in April 2002 and was considered to be possibly related to the second injection of Engerix-B. However, he also indicated that "it is possible the rash represented pityriasis lichenoides acuta, an idiopathic skin eruption unrelated to the vaccine, but this is uncertain."
HAS ALSO EXPERIENCED 4 EPISODES OF CHILLS LASTING 10-15 SECONDS ALSO CONTINUING TO OCCUR
Aching & pain from hand to neck.  & when I move my arm.  Texted  the doctor after three weeks and  she said take tylenol or adlieve.   Tylenol didn't help and I continued to wake with the aching pain at night.  It has been four weeks now and I continue to have aching at the site of injection  and difficulty dressing myself  however it is better.       When I got the injection, it hurt  more than any injection I ever got.   The question I have is  should I get the lower dose next time?
?Covid Arm? red, hot, swelling of left arm under the injection site 48 hours after shot.  Other symptoms, headache, extreme fatigue, chills, low fever.
REDDENED AREAS AT 2 VACCINE SITES ON LEFT ARM.  BOTH AREAS RED, HOT TO TOUCH, AND SLIGHTLY PAINFUL TO PATIENT.
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Additional Details: pt was fasting from past 2 days before getting vaccine
Patient came to vaccination site at 10:14 AM 12/17/2021 and received her Moderna booster. She came back to site an hour later at 11:05 AM to report she was feeling shortness of breath, increased heart rate and pressure to her chest. Vitals signs at 11:05 am were as follows: blood pressure 145/85, heart rate 137, respirations 18, SPO2 100%. EKG showed sinus tachycardia with infrequent PVCs (preventricular contractions). She was able to talk in full sentences at the time, A&O x4 and sitting in her car. She reported a history of anxiety but she does not take anything for it. No history of anaphylaxis, allergic reaction; showed no signs of hives, redness etc. Vital signs at 11:10 am were as follows: 157/81, heart rate 118, respirations 18, SPO2 100%. At this time, she did report that she had some slight tightness in her throat and difficulty breathing. She was given water which helped resolve the issue. No medications were administered at this time. Patient had called her father to come pick her up so she wouldn't have to drive home on her own. Another set of vital signs at 11:15 am: blood pressure 140/96, heart rate 127, respirations 18, SPO2 100%. Patient did not report any past medical history and stated she does not currently have primary care physician. She did report some nausea, confusion and disorientation, fainting with the first Moderna shot, but no side effects with the second Moderna vaccination. Patient's car was parked in a safe location, she was walked to her father's car. Per Safety Officer and Paramedic, patient was told she needs to get checked out by a doctor to follow up on symptoms as soon as possible. If she feels more pressure on her chest, shortness of breath, closing of her airway to stop the car and/or call EMS immediately.
temperature of 100.9; This case was reported by a consumer via call center representative and described the occurrence of fever in a 65-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2020, the patient received the 2nd dose of Shingrix. In May 2020, 1 day after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix and had temprature of 100.9 the next morning. The reporter wanted to know was that normal.
Information has been received from a certified medical assistant concerning a 16 year old female who on 27-FEB-2008 was vaccinated with her first dose of GARDASIL (658094/0524U) and is now pregnant.  Concomitant medication included DOXYCYCLINE from 03-MAR-2008 to 05-MAR-2008 and ZITHROMAX on 06-MAR-2008 for the treatment of Chlamydia and ORTHO TRI-CYCLEN.  The patient's LMP was 25-JAN-2008 with an EDD of 01-NOV-2008. The patient sought medical attention in the office.  Follow up information has been received from a complete questionnaire for the pregnancy Registry for GARDASIL from a Physician concerning a 16 year old female with cervical dysplasia.  During the second trimester of pregnancy in approximately April 2008, the patient experienced a UTI (urinary tract infection) and treated on 16-APR-2008 with ROCEPHIN.  On 04-NOV-2008 there was an occiput posterior (OP) position of the infant and a vacuum assisted delivery was necessary.  The patient delivered a normal, healthy female baby weighting 7 pounds 2.3 ounces.  Additional information was received on 27-MAR-2009, from a certified medical assistant who stated that the patient delivered the baby and the outcome was "fine/normal".  Additional information is not expected.
COVID symptoms developed 4 days later; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 28Mar2021 at 12:45 (at the age of 34-year-old), as a single dose for COVID-19 immunisation. Medical history included sciatica. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) 800mg from an unknown date for an unknown indication. The patient previously received cefaclor (CECLOR) and experienced allergy. The patient did not receive any other vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19.  On 01Apr2021 at 15:00, 4 days after the vaccination, the patient experienced COVID symptoms and was tested positive for COVID five days later. The patient did not receive any treatment for the reported event. On 02Apr2021, the patient underwent a nasal swab test (SARS-CoV-2 test) and the result was positive. The clinical outcome of the event COVID symptoms developed 4 days later was not recovered at the time of the report.   No follow-up attempts are needed. No further information is expected.
11/04/2021 Received booster shot on 04/16/2022 when I woke up in the morning I felt achy, low grade fever, congested, coughing. It lasted till couple of days. I bought a home test and it was positive on 04/17/2022. I call  doctors on demand ( telehealth) they prescribed me Paxlovid it was for 5 days. I felt better on the 3rd day of taking the medication.
I contracted COVID-19 on 06/09/2022 with symptoms of dry cough, sneezing, runny nose, congestion, low grade fever, vomiting, and slight headache. I was prescribed Paxlovid on 06/12/2022. I was ill for 5 days before my symptoms began to resolve. I have fully recovered with no lingering symptoms.
Epstein Barr plus other health issues; This serious case was reported by a consumer via interactive digital media and described the occurrence of epstein-barr virus infection in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included seizure.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced epstein-barr virus infection (Verbatim: Epstein Barr plus other health issues) (serious criteria GSK medically significant). The outcome of the epstein-barr virus infection was not resolved.   The reporter considered the epstein-barr virus infection to be possibly related to Shingrix.     The company considered the epstein-barr virus infection to be possibly related to Shingrix.   Additional Information: GSK Receipt Date: 07-APR-2023 This case was reported by a consumer via interactive digital media. The patient reported that it couldn't be worse than going on third year with Epstein Barr from the vaccine.  The patient was taking anti seizure medication. They also had all the other health issues. This case had been linked with US2023AMR053230 due to same reporter. The reporter think that the event might have been related to the Product/Device.; Sender's Comments:  US-GSK-US2023AMR053230:Same reporter.
I initially had tingling of the lips that started 40 minutes after the injection.  I took Benadryl and Pepcid.  Now the tingling has progressed to upper and lower lip swelling, consistent with an allergic reaction.
He was very very weak, and very off balance.  He fell down and couldn?t get up he was so weak. Mixed up all day.
Nerve pain; Muscle spasms in my legs, chest/muscle apsams chest, legs; Pretty bad rash on her chest and neck; Really bad dizziness; Severe pain like burning in arms and legs; This spontaneous case was reported by a nurse and describes the occurrence of DIZZINESS (Really bad dizziness), PAIN (Severe pain like burning in arms and legs), MUSCLE SPASMS (Muscle spasms in my legs, chest/muscle apsams chest, legs), RASH (Pretty bad rash on her chest and neck) and NEURALGIA (Nerve pain) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy and Hypothyroidism since 07-Jan-2021. Concomitant products included CITALOPRAM HYDROBROMIDE (CELEXA [CITALOPRAM HYDROBROMIDE]) for Anxiety, LEVOTHYROXINE, CITALOPRAM, LEVOTHYROXINE SODIUM (SYNTHROID), CALCIUM, MULTIVITAMIN [VITAMINS NOS] and VITAMIN D NOS for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced DIZZINESS (Really bad dizziness), PAIN (Severe pain like burning in arms and legs) and RASH (Pretty bad rash on her chest and neck). On 08-Apr-2021, the patient experienced MUSCLE SPASMS (Muscle spasms in my legs, chest/muscle apsams chest, legs). On an unknown date, the patient experienced NEURALGIA (Nerve pain). The patient was treated with CORTISONE at a dose of 1 dosage form; PARACETAMOL (TYLENOL) at a dose of 1 dosage form; GABAPENTIN (NEURONTIN) at a dose of 1 dosage form and TIZANIDINE HYDROCHLORIDE (ZANAFLEX) at a dose of 1 dosage form. On 19-Apr-2021, DIZZINESS (Really bad dizziness) and RASH (Pretty bad rash on her chest and neck) had resolved. At the time of the report, PAIN (Severe pain like burning in arms and legs), MUSCLE SPASMS (Muscle spasms in my legs, chest/muscle apsams chest, legs) and NEURALGIA (Nerve pain) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-073972 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow up received and contains Non significant information. On 19-Jul-2021: Significant Follow up- Updated patient details, Updated Allergy and concurrent conditions, Updated concomitant and treatment medications, Updated new event and  events start dates and end dates and outcome of the events.