chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient got a "full dose" (0.5ml) instead of a "half dose" (0.25ml) as her booster.
Lymph node in armpit of injection arm extremely swollen and painful to touch after 4 days.; Lymph node in armpit of injection arm extremely swollen and painful to touch after 4 days.; Lymph node in armpit of injection arm extremely swollen and painful to touch after 4 days.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the parent. Other Case identifier(s): US-PFIZER INC-202200045695 (Pfizer).  A 10 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Jan2022 10:00 (Lot number: FL0007) at the age of 10 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: LYMPH NODE PAIN (non-serious), LYMPHADENOPATHY (non-serious), AXILLARY PAIN (non-serious) all with onset 04Jan2022 10:00, outcome "not recovered" and all described as "Lymph node in armpit of injection arm extremely swollen and painful to touch after 4 days.". The event "lymph node in armpit of injection arm extremely swollen and painful to touch after 4 days.", "lymph node in armpit of injection arm extremely swollen and painful to touch after 4 days." and "lymph node in armpit of injection arm extremely swollen and painful to touch after 4 days." was evaluated at the physician office visit. Therapeutic measures were not taken as a result of lymph node pain, lymphadenopathy, axillary pain.  Additional Information: Seriousness criteria reported as No. Facility where the most recent COVID-19 vaccine was administered was pharmacy or drug store. The patient did not receive any vaccines within four weeks prior to the vaccination. No list of any other medications the patient received within 2 weeks of vaccination. Reported Event: Lymph node in armpit of injection arm extremely swollen and painful to touch after 4 days. Cannot lift arm above head due to pain.  Site of injection is not painful.  Only lymph node is swollen and painful. Adverse events resulted in doctor or other healthcare professional office/clinic visit. Prior to vaccination patient was not diagnosed with covid-19. since the vaccination the patient had not been tested for COVID-19. Customer Verbatim: Please advise if child should receive second dose of vaccine given reaction reported. Product: Pfizer Covid 19 vaccine orange top pediatric. Caller's 10 year old daughter had the first dose of the vaccine. Afterward her lymph nodes became extremely swollen and painful under the injection site for 6 days.    No follow-up attempts are needed. No further information is expected.
Tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0271121b) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: Pfizer (Dose Number: 1 Batch/Lot No: oep6955, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM) on 22-Mar-2021, Pfizer (Dose Number: 2 Batch/Lot No: ew0153, Location of injection: Arm Left and Vaccine Administration Time: 02:00 PM) on 21-Apr-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 06-Dec-2021 at 1:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2022, the patient experienced TINNITUS (Tinnitus). At the time of the report, TINNITUS (Tinnitus) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2022, COVID-19: (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The concomitant drug information contains Flu and Shingles. An unknown drug was reported with allergy as relevant past drug. Lab data contains Nasal Swab test with unknown result.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. No treatment medicine were provided   Reporter did not allow further contact
rash; This is a spontaneous report from a contactable consumer (patient) based on information received by Pfizer from , Inc. (Reference no.: NVSC2021US056465_NS).  A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on an unspecified date for COVID-19 immunisation. Patient said she got a rash after getting her second COVID-19 vaccine (unspecified date). The outcome of the event was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
knee arthritis; Cramping in his legs; Tension in the back of his neck; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Knee arthritis" (ongoing), notes: Knee arthritis. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: MUSCLE SPASMS (non-serious) with onset 04Jan2023, outcome "not recovered", described as "Cramping in his legs"; MUSCLE TIGHTNESS (non-serious) with onset 04Jan2023, outcome "not recovered", described as "Tension in the back of his neck"; ARTHRITIS (non-serious), outcome "not recovered", described as "knee arthritis". Additional information: Caller reports he is having a side effect at the time of report, and he is not sure if he had it with his previous vaccines. Caller states as he was going to bed last night and it has persisted and is here still, it is not dangerous or life threatening but having cramping in his legs and tension in the back of his neck. Caller states the leg cramping is worse. He reports he has knee arthritis, and he is not sure if that anything to do with it. Caller states he was wanting to find out the reason for the leg cramping. He states if it gets bad enough, it can continue to his toes.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
An empty syringe not filled vaccine, MAY HAVE BEEN utilized to "vaccinate" this patient.  This possible error was identified within 24-hours of the event and the parents were informed of the potential error.  The parents have decided to forego immediate re-vaccination and have spike protein antibody titers checked in 2-3 weeks to decide if they will consent to a repeat dose one or continue on to dose two.
pt recv vax w/o consent or approval from parent;wants a double check system put in place;
Slight amount of soreness and swelling at the injection site. Approximately 4 hours after the injection I became very tired and went to bed.  The next day I was back to normal. No treatment necessary.
Entire right arm hurts to the point that it's hard to fall asleep. It's hard to lift it up. It slows me down from carrying out my daily activities. It aches and sometimes I feel a burning sensation. I used blue ice analgesic on it but it didn't work.
Mom called one day post event. States site where varicella was given was edematous, red and hot. Swollen the size of her palm. Mom told to put cooling measures. Call Dr. if worsens.
Dizziness, light sensitivity, HA/migraine, eye pain, stiff and painful neck. TYLENOL was not helpful for pain relief. Symptoms worsened on 10/28, 10/29. Symptoms began to improve on their own 10/31/17.
Patient calling back to Health Clinic after her appt. today c/o "coughing so hard that I have thrown up" - She reports persistent cough for past 2 hours feeling like something "stuck in her throat"- Advised ED eval. with subsequent admission with Dx delayed - anaphylactic reaction to influenza vaccine.
Within 1/2 hour the pt experienced flu like symptoms, has progressively gotten worse. Has been to many doctors. The pt has developed kidney stones, gall stones, weight loss, neurological disorders. The 60 day follow-up states, "since 05/08/1999 my entire immune system has been attacked. Results are kidney problems, bladder, ureter, chronic infections, blood abnormalities, memory loss depression, drastic unwanted weight loss, chronic muscle and joint pain, spasms, loss of muscle tone, deconditioning, irritable bowel syndrome, chest and rib pain, and arthritis and flu-like symptoms over my entire body, which has continually gotten worse since 05/08/1999.
This report A0354931A (formerly 2001026860-1) describes swelling of the hands and feet of a pt who received Lyme disease vaccine. This report has been verified by a physician. Medical history included testing positive for Lyme disease in 1999. The pt received her 1st injection of LYMErix on 10/15/2000; she had no adverse event following this injection. She received her 2nd second injection on 11/20/2000. In 01/2001,reported that she began to experience aching in all her joints. She reported that none of her joints were swollen or warm. She also experienced swelling and tingling in her hands and feet. She was seen by her Dr in Feb 2001. Multiple lab test were performed. The pt reported by June 2001, the tingling in her hand and feet had subsided and the swelling of her hands and feet was markedly decreased. The aching in her joints continued, with no decrease in intensity. With the onset of colder temperatures in the fall of 2001, all symptoms have returned to the same degree as the were in February 2001. The pt declined the 3rd injection of LYMErix. the adverse events aching joints and tingling hands and feet do not meet ICH serious criteria, but are being submitted as an expected report by special FDA request per the June 28, 2000 letter. The most recent information received from the physician on 6/20/02, indicated that the events were ongoing. The physician considered the events to be moderate-to-severe in intensity and possibly related to LYMErix administration. The adverse events of "osteoarthrtiis" and "paresthesia" do not meet serious criteria, but are being submitted as an expedited report by special FDA request per the 6/28/00 letter.
received immunizations at 330 pm on 07/12/07.By 430 pm he got very quiet,wouldn't smile,and just acting odd. Started to run a fever of 102 and they gave him Tylenol. Started to not keep formula down. Both legs are red and swollen. Mother called dr's office and got him an appt. on 7/13. 7/16- called and they saw Dr. on Friday. He told them he is ok and to treat fever. Still had a fever yesterday. He is still fussy today but no temp.
Bad headache, tired, muscle aches, fever, fast heart rate, chest pressure lasting for 1 1/2 days
n/v sore @ injection site fever 100.9 joint pain body aches headaches
Has hx of tinnitus, however there was a dramatic increase in the left ear 4-5 days after the vaccine. Felt a sensation of fullness in the left ear. .
1/4/21 12 hr after vaccine fever of 101.3 bodyache  and  chills .  On 01/05   Joint pain ,chest pain hot sweat    chills and  diarrhea
pt recv vax 10OCT97 & 11OCT97 & pt devel chills, h/a which described as feeling like a sinus h/a;sx cont through Sunday & Monday AM felt heart out of rhythm, having fibrillation, pulse irregular;BP monitor inaccurate;red & sore arm;
Flu like symptoms; Heart palpitations; This is a spontaneous report from a Pfizer sponsored program. A contactable other-Health Care Professional and a non-contactable consumer (patient) reported. This case is a spontaneous report received on 23Apr2021, from a consumer via specialty pharmacy. Initial Reporter Also Sent Report to FDA- UNK.  A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on 20Apr2021 (at the age of 60 years old) as dose 1, single for covid-19 immunisation; treprostinil sodium (REMODULIN), via an unspecified route of administration from 15Aug2019 to an unspecified date, at 5.0 mg/ml, daily (UNK, continuing, (Continued)), subcutaneous from an unspecified date (Batch/Lot Number: 2101734; Expiration Date: 30Nov2021) to an unspecified date, at 0.068 micro g/kg, continuing for secondary pulmonary arterial hypertension; macitentan (OPSUMIT), via an unspecified route of administration from 20Apr2021 to an unspecified date, at unspecified dose for an unspecified indication . Medical history included secondary pulmonary arterial hypertension from an unknown date and unknown if ongoing. Concomitant medication included riociguat (ADEMPAS). It was reported that the patient might took a double dose of Opsumit but she was not sure. The patient also reported having flu like symptoms after COVID vaccination on Tuesday (on 20Apr2021) as well as heart palpitations. On an unreported date in Apr 2021, the patient experienced the events of heart palpitations [Palpitations], flu like symptoms after COVID vaccination. The action taken in response to the events for treprostinil sodium was unknown, for macitentan was unknown. The outcome of event palpitations and influenza like illness was unknown at the time of reporting.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Just a little pain at the injection site and is kind of tired today; Just a little pain at the injection site and is kind of tired today; This is a spontaneous report received from a contactable consumer (patient). A female patient of an unspecified age (reported as 89, unit unspecified) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on 26Jan2021 10:55, at single dose, for covid-19 immunization, at the hospital. The patient medical history was not reported. Concomitant medication included rivaroxaban (XARELTO) from 2020. The patient reported that she had no reaction, just a little pain at the injection site in Jan2021 and was kind of tired on 27Jan2021 (today). The patient also reported that after she got the vaccine, they gave her a fact sheet. She just read it in the morning of 27Jan2021 (this morning). It said that you should mention if you have any allergies, fever, bleeding disorders, or are on a blood thinner. The patient stated she is on XARELTO for over a year now. The patient was wondering what complications would arise from this. The outcome of the events was unknown.  Information about the lot/batch number has been requested.
little soreness in shoulder and arm; little soreness in shoulder and arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (little soreness in shoulder and arm) and ARTHRALGIA (little soreness in shoulder and arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history 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 PAIN IN EXTREMITY (little soreness in shoulder and arm) and ARTHRALGIA (little soreness in shoulder and arm). At the time of the report, PAIN IN EXTREMITY (little soreness in shoulder and arm) and ARTHRALGIA (little soreness in shoulder and arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication provided No concomitant medication provided
Dizziness, NauseaVomiting,  MILD HA  Narrative:  1035: C/0 DIZZINESS, NAUSEA (MILD), MILD HA 191.115 HR69 1036: NO CHANGE IN SYMPTOMS 171/103 HR71 10:45 SYMPTOMS GONE 158/96 HR 67 1055 D/C STABLE 147/88 HR 65 INTERVENTION:  WATER
Swollen eye; Rash on neck; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (Swollen eye) and RASH (Rash on neck) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced RASH (Rash on neck). On an unknown date, the patient experienced EYE SWELLING (Swollen eye). At the time of the report, EYE SWELLING (Swollen eye) and RASH (Rash on neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Solid red spot began to grow and swell to about 5 inches in diameter within 2 days. Began to spread down the arm.
This medically confirmed spontaneous report (initial receipt 31-Jan-2012) concerns a 67 year old male patient with a medical history of genital herpes. Concomitant therapy included acyclovir, atorvastatin, testosterone gel, paroxetine, combined lisinopril and hydrochlorothiazide. On 30-Nov-2011, the patient received the flu vaccine and ZOSTAVAX. The day after receiving vaccination, on 01-Dec-2011, the patient developed a papular rash on the left groin, the right upper arm and chin, with secondary impetigo on the chin. The reporter stated that 24-48 hours after vaccination, the patient experienced a slight headache and developed 3 'zoster like bumps', not fluid filled. There was one zoster like bump on the arm where the vaccine was not administered, one zoster-like bump was observed in the patient's groin area and one zoster like bump was on the patient's chin. The zoster-like bump on the patient's chin was infected and the patient developed cellulitis on his neck. The patient was treated with cephalexin for a few weeks before resolving. The papular rash and secondary impetigo on the chin resolved on 20-Dec-2011. Patient outcome is not yet recovered.
Information has been received from a physician concerning a male patient in the kindergarten age range who was vaccinated with only one 0.5 ml dose of VARIVAX (Merck) on unspecified date. Within the last 2 weeks, in May 2010 the patient came to the office with case of chickenpox. At the time of the report, the outcome was unknown. Additional information has been requested. This is one of several reports received from the same source.
Generalized rash, flares up; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of RASH (Generalized rash, flares up) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Medical history was not provided).    In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form(s). On an unknown date, the patient experienced RASH (Generalized rash, flares up) (seriousness criterion hospitalization). The patient was hospitalized for 3 days due to RASH. At the time of the report, RASH (Generalized rash, flares up) had not resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient was in hospital for 3 days. The patient had multiple consults and on 7 different medications.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD21-079683, MOD21-079684, MOD21-079685 (Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. MOD21-079683:2nd Patient case report MOD21-079684:3rd patient case report MOD21-079685:4th patient case report
Itching four 12 hours starting about 20 minutes after administered (stopped after 50mg po Benadryl). On 3/20 developed pain in R jaw/cheek area, started OTC ibuprofen. Seen at employee health on 3/30/15 and given tramadol for the pain; returned to employee heath on 4/6/15 and had panorex x-rays done; diagnosed with viral parotitis secondary to MMR vaccine. Continue to follow up with employee health since symptoms continue.
This case was reported by a nurse via call center representative and described the occurrence of rash in a adult female patient who received FLULAVAL Quadrivalent (batch number H33J2, expiry date May 2016). On 7th October 2015, the patient received the 1st dose of FLULAVAL Quadrivalent .5 ml. On 8th October 2015, 1 days after receiving FLULAVAL Quadrivalent, the patient experienced rash, injection site swelling and injection site redness. On 12th October 2015, the outcome of the rash, injection site swelling and injection site redness were recovered/resolved. The reporter considered the rash, injection site swelling and injection site redness to be related to FLULAVAL Quadrivalent. Additional details were provided as follows: The patient was an employee of the facility. The nurse reported that the next day after receiving FLULAVAL QIV, the patient experienced a severe injection site reaction with increased swelling in the upper deltoid. The deltoid was red (injection site redness), swollen (injection site swelling) and a noticeable rash on the entire left arm. The symptoms lasted for 3 days until they resolved.
4 CM Red Circle around injection site, Red, hot and swollen. Painful to move arm.
patient reported localized pain at injection site day of shot 02/11/21. called into general advice line to report results worsening symptoms of whole body aches, fever, HA, whole body itchy rash with no shortness of breath or airway compromise. given delayed reaction, sounds most like side effect  and is not consistent with anaphylaxis but recommended ED/911 if develops airway compromise, and discussed possibility could be allergic
Initial information regarding an unsolicited valid non-serious case received on 10-Oct-2018 from a nurse. This case is linked to cases 2018SA284746, 2018SA284721, 2018SA284749, 2018SA284750, 2018SA284751, 2018SA284752, 2018SA284753, 2018SA284754, 2018SA284755 and 2018SA284748. (Same reporter). This case involves a patient (age and gender was not reported) who was vaccinated with a dose of FLUZONE QUADRIVALENT (lot number and expiry date not reported) lot U1997AA via intramuscular route in the left deltoid on 03-Oct-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage (patients were given vaccines that were outside of the recommended temp range) and Deteriorated drug administered. No information about any adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.