chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I got the Maderna vaccine and 2 days later my eyes we swollen and watery. I also could not stop sneezing continuously. Now I have been sneezing still continuously throughout the day ever since. Have never had this before and I normally do not have allergies.
tender arm; 17 years old received 1st dose of Moderna COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old received 1st dose of Moderna COVID-19 vaccine) and PAIN IN EXTREMITY (tender arm) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     The patient's medical was not reported.     On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old received 1st dose of Moderna COVID-19 vaccine). On an unknown date, the patient experienced PAIN IN EXTREMITY (tender arm). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old received 1st dose of Moderna COVID-19 vaccine) and PAIN IN EXTREMITY (tender arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient's concomitant medication was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-101826 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Email reply stated patient tolerated vaccine shot. Arm tender with no additional AE On 01-Jun-2021: Initial Additional-2 : AE detail and outcome; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-101826:
patient presented w/ acute onset Chest pain, tachycardia  Found to have cardiomegaly on xray elevated BNP, elevated CRP and Echo with severe decreased Left Ventricle Function
Pt recvd 1st dose of vax 04JUN91; 10 days post vax exp malaise, h/a & aches; no tx given;
Ten days after vaccination noticed itching and redness at injection site. Red blotchy area approximately 3 inches in diameter. No pain, not tender to pressure. No evidence of insect bite. May be responding to oral antihistamine and topical cortisone cream.  Have not sought medical advice.
No adverse event to patient. Daughter and son-in-law living in same house got chicken pox and shingles, respectively.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Feb2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 59 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), in Jan2021 as dose 1, single (Batch/Lot number: unknown), in Feb2021 as dose 2, single (Batch/Lot number: unknown) and in Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Migraine" (unspecified if ongoing), notes: Other medical history: Migraine; "Known allergies: Eye numbing drops" (unspecified if ongoing), notes: Known allergies: Eye numbing drops. Concomitant medication(s) included: TOPIRAMATE, start date: Nov2021; FAMOTIDINE, start date: Mar2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: She took topiramate 50mg daily for migraine headache prevention. At first she had lots of side effects from topiramate, which went away after several months. While she took Paxlovid the side effects came roaring back: paresthesia, brain fog, word-finding difficulties. They stopped after the Paxlovid course ended. She was on other medication in 2 weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Cataract; This case was reported by a pharmacist via call center representative and described the occurrence of cataract in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced cataract (serious criteria GSK medically significant). On an unknown date, the outcome of the cataract was unknown.   It was unknown if the reporter considered the cataract to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had cataract. The patient would received 2nd dose of Shingrix on 19th June 2020 but the patient also had been schedule with cataract surgery 5 days later. The reporter was consented to follow up. No further details were reported by reporter.
WENT TO THE EMERGENCY ROOM THEY SAID IT WAS HEART; RIGHT ARM WAS 100 PERCENT NUMB FROM THE ELBOW TO FINGER TIPS AND NO FEELING IN PINKY; This spontaneous report received from a patient 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 was not reported, administered on MAR-2021 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 APR-2021, the patient experienced went to the emergency room they said it was heart. On APR-2021, the patient experienced right arm was 100 percent numb from the elbow to finger tips and no feeling in pinky. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from right arm was 100 percent numb from the elbow to finger tips and no feeling in pinky, and the outcome of went to the emergency room they said it was heart was not reported. This report was non-serious.
covid test date: 03Jan2021, covid test result: Positive; covid test date: 03Jan2021, covid test result: Positive; This is a spontaneous report from a contactable Other Health Professional (patient).  A 37-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, lot # EJ1685) at single dose at left arm on 02Jan2021 11:45 for covid-19 immunisation.  Medical history included post-traumatic stress disorder (PTSD), anxiety. No allergies to medications, food, or other products. Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient has received no other vaccines within 4 weeks prior to the COVID vaccine. On 03Jan2021 the patient has been tested for COVID-19 with rapid nasal swab test resulted positive. It was unknown if treatment was received. The outcome of events was unknown. Later the patient received the 2nd dose of bnt162b2 (BNT162B2, Lot # EL0140) at single dose at left arm on 23Jan2021 for covid-19 immunisation, administered at Pharmacy or drug store. The patient's concomitant medications in 2 weeks of this vaccination included: Lamictal, Klonopin, multivitamins, D, C, B, Zinc. On 24Jan2021 12:00 AM the patient experienced extreme tiredness, chills, fever, muscle aches, runny nose, sore throat, nausea, pale skin, malaise, night sweats. No treatment received for the adverse events. The outcome of events was recovering.; Sender's Comments: No effect of the suspect vaccine BNT162B2 could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag. Instead, the positive COVID represents the pre-existing infection prior to vaccine use. Further information like confirmative COVID 19 nucleic acid/ PCR test together with any associated symptoms are needed for full medical assessment.
Swollen arm with intense itching and felt like bees stinging me over and over with severe pain from my shoulder to my wrist.  Over the counter meds did little to help.  This lasted 4 days.
Patient Receive second dose of Hep A and a PPD test. A few minutes after receiving the vaccines patient step out of immunization door and fainted.  Everyone was notified to intercom for Code Blue and doctors came right away to assist patient.  Patient was brought back to immunization room and laid down. 2-3 Minutes later patient woke up and was given a drink of water.  Pt feels better and was discharged by the doctor.
Pt received vaccine at 1025,waiting to finish his 15 min observation.At10:38 pt called the RN observer because he felt lightheaded. RN came to help him ,30 sec later, pt fainted and loss consciousness for about 10 sec. Assisted to the floor in T-position. 911 called.Pt regained consciousness, BP and O2 saturation monitored. Initial BP 102/57, 10:46 107/62,10:50 115/72,10:56 131/74. 10 Pt is alert, sat up in a chair.911 arrived
Patient has not reported any adverse events or side effects.  Upon the 2nd pediatric dose, it was discovered that the 1st dose was administered as an adult dose.
pt recvd vax in the AM & reportedly devel fever that evening; was admitted to hosp during the next week & died exactly 1 wk from the vax date reportedly of a bacterial infect in blood;
Tachycardia; Tingling in the arm and head; fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an occupational therapist (subsequently medically confirmed) and describes the occurrence of TACHYCARDIA (Tachycardia), PARAESTHESIA (Tingling in the arm and head) and PYREXIA (fever) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 1016) for COVID-19 vaccination.     Concurrent medical conditions included Premature ventricular contractions and Seasonal allergy.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced TACHYCARDIA (Tachycardia), PARAESTHESIA (Tingling in the arm and head) and PYREXIA (fever). At the time of the report, TACHYCARDIA (Tachycardia), PARAESTHESIA (Tingling in the arm and head) and PYREXIA (fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment for these events included Benadryl at night and Diltiazemer 120 mg per day.
10:00am Immediately following receiving PROQUAD, SQ R-thigh had redness & swelling of inj. site. Cold compress applied & ibuprofen given. After one hour, redness & swelling decrease. No difficulty breathing. At 2:18pm, redness & swelling decreased. 10/22/2022 mother reports RT thigh is fine.
Itchy skin,  hives, redness and welts on back of my head, Rash on my forearms, chest, stomach, back, neck and legs
Patient recieved Pneumococcal vaccine on 3/19/2008 in the morning.  Patient developed swelling of the arm from his shoulder nearly to his wrist on by 5 or 6 p.m.  Went to the emergency room appox midnight.  Was given antibiotics and prednisone for cover cellulitis. Patient as contacted on 3/21/2008 and advised symptoms were improving.
discomfort noted in upper rt arm on 22APR97 inc s/s on 22APR97;edema, redness 15 x 10cm, warm to touch, itchy, t97.4 oral, BP 162/102;sent to clinic for assessment;tx DPH;
Local rxn w/swelling & redness cleared around inject site but settled around lt elbow by 3d post shot; Resolved w/time & Keflex for poss cellulitis/arthritis;
Swelling and redness on left thigh 10cm X 10cm. Treated with warm packs.
Fever; This is a spontaneous report from a contactable other health professional. A 39-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EN5318, via an unspecified route of administration on 29Jan2021 15:30 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 on 08Jan2021, 22:00 in the Left arm, for COVID-19 immunization (first dose). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The patient experienced fever on 30Jan2021 09:00. The outcome of event was recovered. The patient did not receive any treatment   due to the event.  Follow-up attempts are completed. The following information on the batch number has been obtained.
2-9-07 11:30 site began swelling and turning red-Temp 99. 22:30 site much more swollen and redness to elbow-Temp 101. 08:00 2/10/07 arm swollen 2x size of other arm and red streaks all the way down arm-unable to move arm-crying. 19:30 to ER-diagnosed cellulitis Treatment Sulfameth-Trimeth. 1 1/2 tsp bid for 7 days, Hydroxyzine 10 mg 1/2 tsp every 4 hours, Advil every 8 hours.
Hospitalized 12/26/2021; COVID-19 positive 12/26/2021; fully vaccinated plus booster  BRIEF OVERVIEW:  Admission Date: 12/26/2021 Discharge Date: 01/03/2022 HOSPITAL COURSE: a 91 y.o. male with history of insulin-dependent type 2 diabetes, coronary artery disease, CKD 3 A who presented with weakness and cough.  Patient was found to have COVID with mild hypoxia requiring oxygen.  He was started on Decadron PT and OT were consulted who recommended subacute rehab. Physical therapy and occupational therapy reassessed on 1/2 when patient was out of isolation and confirmed this..    Consults: None   Procedures: None    "   Interim hospital course:  Patient hospitalized for acute hypoxic respiratory failure secondary to COVID-19 pneumonia.  Patient was treated with Decadron with improvement in his symptoms weaned to room air and stable with his oxygen saturations prior to discharge.  Patient was also seen by PT OT for generalized weakness with recommendation for subacute rehab which he will discharge to in stable medical condition on 01/03/2022.  In regards to his insulin he had been requiring Lantus 48 units during his stay while on Decadron, dexamethasone will be discontinued at discharge and insulin will be reduced to 35 units from his home 30 units given that he will not be on Ozempic while at subacute rehab.  Recommend patient follow-up with his home primary care physician, other medications remain the same at discharge.  Do recommend the patient continue to hold midodrine given his normotensive pressures here in the hospital.  Of note patient did have an EKG at the onset of his hospitalization that was noted by previous physician read as AFib, I do note P waves although does appear irregular with PVCs would recommend routine cardiology follow-up as deemed necessary by primary care physician following repeat EKG on follow-up care as an outpatient.
rectal bleeding; pain; nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (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: RECTAL HAEMORRHAGE (medically significant), outcome "unknown", described as "rectal bleeding"; PAIN (non-serious), outcome "unknown", described as "pain"; NAUSEA (non-serious), outcome "unknown", described as "nausea".  Clinical course: The reporter stated that three people complained of rectal bleeding, pain, and nausea.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200343093 same reporter/drug/events, different patients;US-PFIZER INC-202200343092 same reporter/drug/events, different patients
No further AE details provided; PROQUAD was administered to a patient after a temperature excursion; This spontaneous report has been received from a nurse, regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 13-JUN-2023, the patient was vaccinated with an improperly storage dose of measles, mumps, rubella and varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (rHA) subcutaneous injection, at a dose of 0.5 milliliters once as prophylaxis (W024552, which was determined to be valid, with an expiration date on 31-JAN-2024) (strength, route of administration and anatomical location of administration were not reported), in combination with a sterile diluent.  The administered dose underwent a temperature excursion via digital data logger of 12.84 degrees Fahrenheit for 25 minutes. There was a no previous temperature excursion reported. No further adverse event details provided.  Follow-up information has been received from a nurse regarding a 4-year-old female patient, on 25-JUL-2023.  Her concomitant medications included polio vaccine (POLIO), pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) and hepatitis a vaccine (HEPATITIS A VACCINE).   On 22-MAY-2023, the vaccine freezer was open to allow for scraping ice from sides. The door was left open too long, temperature excursion occurred and was inaccurately reported to manufacturer. The temperature excursion did not occur as a result of a reading from a Digital Data Logger (previously reported that temperature excursion was via Digital Data Logger, conflicting information). On 13-JUL-2023, the patient was vaccinated with an improperly stored vaccine of measles, mumps, rubella and varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), first dose, administered subcutaneously in right thigh, and it was administered by a heathcare professional. The vaccine was administered according to the instruction leaflet and it was not available for return/evaluation. On 11-JUL-2023, the vaccine was properly reported to manufacturer and deemed safe for use. The patient received vaccine and did not have any medical events occur as a result of temperature excursion. This vaccine was no  longer in stock.  This is one of four cases received from the same reporter.  This case was previously considered non-valid but upon receipt of follow-up it was determined to be valid as patient's identifiers were provided.; Sender's Comments:  US-009507513-2307USA002154: US-009507513-2307USA002433: US-009507513-2308USA001000:
Aching over whole body. Then headaches and general malaise worsening. Severe sore throat by 06.09.2011 developing to full flu symptoms still continuing today 14.09/2011. Managing them at home since I have nursing experience.
This is a 26 year old male who states that he received the flu vaccination in the L upper arm and the PNEUMOVAX in the R upper arm. All was fine until approx 36 to 48 hrs after injections, the R arm where he received the PNEUMOVAX started aching, then within 12 more hrs the entire R arm was hurting. There was some itching at the site, he has noticed a red spot where the shot was given on the R arm. In the last 24 hrs he has noticed slight swelling of the R hand and it hurts the forearm with gripping. He denies any fevers, chills, wheezing, tongue swelling, hives or other rashes, CP, previous blood clot issues, red streaks on R arm. He has never had reaction to a vaccine prior. He relates the L arm flu vaccine site is not bothering him at all. Skin and Subcutaneous Tissue General Inspection: R arm upper lateral aspect (deltoid region) is a 5cm x11cm region of slight pink the R arm is tender in diffuse nature circumferentially from the above mentioned superficial pink discolored spot upper arm down to mid forearm, no edema of hand, the R forearm is 1 cm larger diam than L forearm, the biceps region is same size L and R, no cords, grip is 5/5 bilaterally symmetric, light touch is intact and symmetric in hand/forearm/ upper arms. Radial pulses intact bilateral, good symmetric temp to palpation of both hands and upper arms, no crepitus of skin, no red streaks, no palpable abscess noted, FROM shoulder, elbow, wrist and fingers.
11/28: Pt. rec'd shot at 1:30 pm. 11/29: Temp 102.1 degrees. RPh recommended MOTRIN. 11/30: Temp 100 degrees. Pt. still taking MOTRIN. 12/1: Red, inflamed, hot below site of injection. Pt. visited MD. MD filled antibiotic. No local site rcn. till 12/1.
I don't feel good; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (I don't feel good) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CORTISONE for an unknown indication.    On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (I don't feel good). At the time of the report, MALAISE (I don't feel good) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.
This spontaneous report as received from registered nurse refers to a 44 year old female patient. Patient's concurrent conditions and relevant medical history was unknown. On 10-SEP-2014 the patient was inadvertently vaccinated with PNEUMOVAX 23 (dose and route unspecified) (lot number: J011651 with expiry date of 22-AUG-2014). Concomitant medications were unkonwn. The patient sought medical attention. The outcome of the events was unknown. The causality of the events with PNEUMOVAX 23 was not reported. Additional information has been requested.
Redness, swelling, pain, left deltoid, circumference of redness 3 inch by 3 inch.
This spontaneous report was received from a Registered Nurse. On 07-JUL-2014, the reporter requested stability for doses of PNEUMOVAX23 which were evaluated and supported. On 22-JUL-2014, the reporter was requesting stability data for an additional temperature excursion, and she reports that the doses of PNEUMOVAX23 (dose, frequency and route unknown) that were supported on 07-JUL-2014, have been administered to unspecified number of patients on unspecified dates since 07-JUL-2014. Concurrent conditions and relevant medical history of the patients was unknown. Concomitant medications were not reported. No adverse effect was observed or reported. This case is linked to #1407USA012043 and # 1407USA012379 via same reporter link. Additional information has been requested.
6 x 7 cm swelling with redness, warmth, pain to (L) deltoid.
A nurse reported that a 74 year old female received a dose of Pnu-Imune 23 vaccine on 6/28/01. On 7/2/01, she developed an injection site reaction characterized by redness and swelling which extended to the elbow. The pt was prescribed Benadryl and antibiotics. On 7/9/01, the pt was hospitalized with palpitations. No further information was available at the date of the report.
Longer than an 8 day menstrual cycle. At first I didn?t think this was weird but it turns out that many of my women friends are experiencing longer periods, and friends who went through menopause a long time ago are having hot flashes like menopause again. I know of about 6 people now. So that?s when I thought my daughters extra long menstrual cycle could be an adverse event.