chrisvoncsefalvay/vaers-outcomes huggingface dataset:
HCP believes 40y/o patient is not immunocompromised; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 40-year-old patient who received Herpes zoster (Shingrix) (batch number J9B25, expiry date 14th September 2023) for prophylaxis.   Concurrent medical conditions included depression, hypertension, chronic kidney disease stage 3, gastric bypass, hyperlipidemia, hyperkalemia, hyperglycemia, impaired fasting glucose and immunocompromised.   On 19th October 2022, the patient received the 1st dose of Shingrix. On 19th October 2022, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 19-Oct-2022 Reporter's comment: The healthcare professional reported that the patient received the first dose of Shingrix. The provider ddi not believed that patient was immunocompromised. The patient had the following conditions depression, HTN, chronic kidney disease stage 3, gastric bypass, hyperlipidemia, hyperkalemia, hyperglycemia, impaired fasting glucose.  The reporter consented to follow up.  Additional supportive information: The 40 year patient received a dose of Shingrix, which led to inappropriate age at vaccine administration.
This spontaneous case, initially received from a nurse on 27-Nov-2017, concerning a female patient of an unspecified age. The patient's medical history and concomitant medications were not reported. On 18-Oct-2017, the patient was administered with AFLURIA (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number: XF30306 and expiry date: 28-Jun-2018). On an unspecified date, after the vaccination, the patient complained of sound like motorcycle motor in her ear and described vibration as a noise similar to the back windows of the car up and the front ones down (tinnitus). It was reported that, the patient felt better ("but event come and go"). No treatment was taken for the event. The patient had recovered from the event (reported as couple of weeks ago). The reporter assessed the event as non-serious and considered the causality of the event as related to the suspect vaccine. Follow up received on 28-Dec-2017: The outcome of the event was updated from not recovered to recovered. The narrative was amended accordingly. Significant case correction received 27-Nov-2017 on 28-Nov-2017: LLT was changed from tinnitus to ear noises for the event "Patient complains of feeling like she hears a motorcycle motor in her ear/Described vibration as a noise similar to that occurring when one has the back windows of the car up but the front ones down". Amended narrative accordingly. Non-significant case correction received 27-Nov-2017: Was changed from 27-Nov-2018 to 27-Nov-2017. Non-significant case correction received 27-Nov-2017: Case comment was corrected.
Fluzone HD administered to 63 year old patient/no AE; Fluzone HD administered to 63 year old patient/no AE; Fluzone HD administered to 63 year old patient/no AE; Initial information received on 23-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 63 years old female patient received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 21-Sep-2019, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ251AB via intramuscular route in the left deltoid.  It was of actual medication error due to inappropriate age at vaccine administration, off label use and overdose.  It was unknown where adverse event was experienced or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC 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.
little cranky after 1st dose; pain at the injection site after 1st dose; This spontaneous case was reported by a patient family member or friend and describes the occurrence of FEELING ABNORMAL (little cranky after 1st dose) and VACCINATION SITE PAIN (pain at the injection site after 1st dose) in a 3-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: IPV on 22-Jul-2022, HEPB on 22-Jul-2022 and PCV13 on 22-Jul-2022. Past adverse reactions to the above products included No adverse event with HEPB, IPV and PCV13.    On 29-Jun-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (little cranky after 1st dose) and VACCINATION SITE PAIN (pain at the injection site after 1st dose). At the time of the report, FEELING ABNORMAL (little cranky after 1st dose) and VACCINATION SITE PAIN (pain at the injection site after 1st dose) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medication was provided. Patient height was reported as 3 feet. Patient had no history of Myocarditis/pericarditis No treatment medication was provided.   This case was linked to MOD-2022-623915 (Patient Link).
Approx 25 minutes after vaccination, client developed mild, red, raised rash with itching on lateral left wrist distal to injection site.  Client denies any other adverse signs/symptoms of angioedema or anaphylaxis 1 hour after administration of vaccine.
I had the tetanus booster shot on Friday Feb 25 around 10am. Friday night my arm ws sore and I has light fever.  Saturday morning, I had fever, body ache and sore arm. Saturday evening I had chills, 102 degree fever, severe headache and body ache. All day Sunday, I had chills, headache, body ache and high fever (103). Its Wednesday today and I am still having light hadache and my arm still hurts.  I was told that I was being given a shot for tetanus booster. I do not know the name of medicine or the manfc.  I just picked and item fom the list in box 13 in order to complete this form.
feeling dizzy; any MODERATE exertions eg, walking at a moderate pace or making a bed were met with shortness of breath which still remains; felt tired; slight increase in joint soreness; oxygen at 85/ oxygen level has again dropped to mid 80's; Oxygen levels down to mid 80s; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (feeling dizzy), OXYGEN SATURATION DECREASED (Oxygen levels down to mid 80s), OXYGEN SATURATION DECREASED (oxygen at 85/ oxygen level has again dropped to mid 80's), DYSPNOEA (any MODERATE exertions eg, walking at a moderate pace or making a bed were met with shortness of breath which still remains) and FATIGUE (felt tired) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939903 and 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Lung disease (Small vessel lung disease), Breathing difficult and Arthritis. Concomitant products included GUAIFENESIN for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced OXYGEN SATURATION DECREASED (Oxygen levels down to mid 80s). On 18-Nov-2021, the patient experienced OXYGEN SATURATION DECREASED (oxygen at 85/ oxygen level has again dropped to mid 80's). On an unknown date, the patient experienced DIZZINESS (feeling dizzy), DYSPNOEA (any MODERATE exertions eg, walking at a moderate pace or making a bed were met with shortness of breath which still remains), FATIGUE (felt tired) and ARTHRALGIA (slight increase in joint soreness). At the time of the report, DIZZINESS (feeling dizzy), OXYGEN SATURATION DECREASED (oxygen at 85/ oxygen level has again dropped to mid 80's), DYSPNOEA (any MODERATE exertions eg, walking at a moderate pace or making a bed were met with shortness of breath which still remains) and FATIGUE (felt tired) had not resolved, OXYGEN SATURATION DECREASED (Oxygen levels down to mid 80s) had resolved and ARTHRALGIA (slight increase in joint soreness) outcome was unknown.            Other Concomitant medications include: Asthma medication for lungs. No Treatment medications were reported. She had a normally scheduled mammogram, and did her mammogram after the vaccination, which she said she was told by her HCP they did not recommend to receive a mammogram close to the time of vaccination.   This case was linked to MOD-2021-387946, MOD-2021-018630 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Nov-2021: Added the new events and current medical condition (Arthritis).
Redness, swelling at injection site fatigue, nausea, weak to the point of not being able to get up.
pt recvd vax; exp local rxn (size of grapefruit) consisting of redness, induration/swelling; tx w/ dph, pred & cold compresses
Feeling disoriented; Inability to recall; A report was received from a consumer concerning a 72 years old elderly female patient MOD21-01139 who experienced disorientation and inability to recall after receiving the Moderna COVID-19 vaccine. The patient's medical history was not provided. No relevant concomitant medications were reported but expressed that the patient regularly takes supplements (unnamed).  The patient received her first of two planned doses of mRNA-1273 on 31 DEC 2020 intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 01 JAN 2021, she reported that she had experienced disorientation after receiving the vaccine. The patient stated that she gave her neighbor's phone number to her sister but could not recall doing that. The exact time interval between the vaccine administration and the event was not provided. The patient's disorientation was said to have lasted for 75 minutes before resolution. No action was reported to have been taken to aid resolution. No treatment information was provided.  Any action taken with mRNA-1273 in response to the events was not reported.   The events were considered recovered/resolved. There is no information regarding a recurrence of the event, or any residual effects of the event on the patient. The patient consented to follow-up with Safety.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
After receiving the vaccine, during the observation  period, developed itchiness in the throat and SOB. Taken to observation, IV started, 4L O2 by NC placed, EpiPen given Observed and then discharged home in stable condition
Initial misuse report received from a healthcare professional on 04 September 2013. A patient (date of birth and gender was not reproted) had received MENOMUME vaccine) intramuscularly instead of subcutaneous. No adverse event was reported. Documents held by sender: none.
Pt developed lymphadenitis in L arm, beginning in axillary region . Tenderness spread down pt's arm and L lateral chest area.
Information has been received from a physician concerning an 18 year old female who was vaccinated with two doses of Gardasil at two different times. Concomitant therapy included MENACTRA. The patient had experienced two similar symptoms after each vaccination. Post dose one, the patient experienced fever for 3-4 days and joint aches. Post dose two, the patient experienced an intermittent fever for two months as well as ulcerations or blisters in her mouth. The physician had diagnosed the blisters as a form of herpes. After the second dose the patient had experienced significant respiratory issues. The patient's outcome was not reported. Additional information has been requested.
Patient woke up the morning after receiving the vaccine with a very stiff neck, fussy/crying, complaining of pain in posterior neck.  Somewhat improved when seen in clinic several hours later.  Unclear if related to vaccine.
patient had received an expired Fluzone HD vaccine/ No AE; Initial information received on 21-Jan-2021 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 57 year old female patient who vaccinated with an expired dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] inadvertently (expired product administered).  Medical history, medical treatment, vaccination, concomitant medications and family history were not provided.  On 21-Jan-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ249AA and expiry date: 30-Apr-2020) via unknown route in unknown administration site.  It was a case of actual medication error due to expired vaccine used.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC 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.
Pt. says arm really sore after getting flu shot. She had taken TYLENOL & heat pad treatment, but pain not going away. May seek medical attention.
At 12:45, AM, my son got chilled and began shaking uncontrollably. He began running a 103 fever,. The fever, would drop to 101 with Tylenol, but would spike as soon as it would wear off.   He was very tired and  slept most of today. Today, the fever is gone, but his back hurts and so does the injection site.
1 hour afterwards with severe arm burning and bright red spreading rash. Pt went to ED. She had spreading rash to her elbow and was having severe burning. Got vaccine at 3:30 and went to ED by 6:00PM got benadryl and Decadron. 4/21 arm and elbow is still bright red and burning.
A non-serous spontaneous report of headache, nausea, vomiting, and diarrhea has been received from a consumer concerning a 40-year old male subsequent to FLUMIST. No medical or medication history was provided for this patient. The patient received FLUMIST on 13-Sep-2008. The patient started having slight symptoms on 15-Sep and 16-Sep-2008. The patient was reportedly "bending over" by 17-Sep-2008. The patient was not seen by a physician for treatment. The patient did not receive treatment for the adverse events but had lots of rest. The patient recovered from the adverse events on 17-Sep-2008. The reporter assessed the relationship of the adverse events to FLUMIST as "not sure", but we think so."
Systemic: Anaphylaxis-Severe, Systemic: Seizure-Severe
Patient is 17 y/o and should have received a pediatric dose. Adult dose was administered in error.
The pt had a seizure at home under 1/2 min. The pt also experienced a fever of 102.4, blood pressure rose to 106 in ambulance. The pt was taken to the ER.
Patient reports lower lip started swelling. She went to PCP @ O:oo AM and received a steroid shot.  Reports lower lip swelling resolved.
The patient reported awaking around 2am the morning after receiving her flu vaccine with sudden itching of her extremities, airway swelling and dyspnea. She used an "old" albuterol inhaler and took oral Benadryl. She reports this resolved her symptoms and they had not returned at the time of phone call with clinic nurse 11 hours later.
pt recv vax 6/97 & in 2/98 pt exp chickenpox
fever; chills; sore arm; muscle aches; headache behind my eyes; fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Jan2021 (Lot number: 30155BA) at the age of 65 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "AFib" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Oseltamivir, reaction(s): "Allergies: Oseltamivir". Vaccination history included: Bnt162b2 (1st Dose, Lot: 30155BA, Location: arm Left), for COVID-19 immunization, reaction(s): "Sore arm". The following information was reported: PYREXIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "fever"; CHILLS (non-serious) with onset 2021, outcome "recovered" (2021), described as "chills"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "sore arm"; MYALGIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "muscle aches"; HEADACHE (non-serious) with onset 2021, outcome "recovered" (2021), described as "headache behind my eyes"; FATIGUE (non-serious) with onset 2021, outcome "recovered" (2021), described as "fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, chills, pain in extremity, myalgia, headache, fatigue.  Additional information: Patient received third dose. The patient received other medications in two weeks. The facility where the most recent COVID-19 vaccine was administered Public Health Clinic/ Administration facility. 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 has been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Starting within a few hours after receiving the booster dose, I got a swollen painful lymph node on the left side of my collar bone and I had experienced flu like symptoms and a fever of around 102. These symptoms lasted for about 36 hours. I had the same exact symptoms after the 2nd dose of the Moderna. I was exposed to COVID on 01/10/2022 and on 01/11/2022 I started experiencing symptoms (the swollen lymph node in the collar bone area) and I took an at home test which was negative. The next day I felt worse and had body aches, chills and flu-like symptoms. I took an at home test on 01/13/2022, which was positive and then 01/14/2022 I got a PCR test which came back positive on 01/15/2022. The infection lasted 9 days and on the 01/24/2022 I tested negative and I returned to work on 01/25/2022. Ever since returning to work, I am experiencing the same lymph node pain in the collarbone area almost daily on an intermittent basis. I saw my doctor and got an ultrasound of the collarbone area but everything was normal; however, I am still in pain and they are unsure why.
The client's sister also received an immunization and was discussing other shots she'd received in the armed forces. Client stated she felt dizzy.  I had her sit for several minutes. She said she felt better and walked to the waiting room where she began to faint.  We lowered her to the floor.  We sat with her for several more minutes and gave her some cold water.  She said she hadn't eaten any lunch and hadn't had much liquid today. I walked with her to the front door after she stated she felt much better.  Her sister was to drive her home.  She said she would eat something when she got home.
Mother of child called stated son had reaction after giving vaccination of IPV, DTAP, MMR and PCV7. Child had temp of 102F, left arm swelling, redness and warm to tough. Mother said gave son Tylenol and Motrin and temp went down after 3 hrs. Advised mother to continue Tylenol if still with high temp and /// swelling and abnormal swelling and .///.
Pt recvd 1st dose of Hep B vax on 25APR91 & on 9MAY91 pt noted a worsening of rash as far as severity & extent; pt devel a bronchial spasm & wheezing;
Bad pain from forearm to her hand; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 43 year-old female patient received bnt162b2 (BNT162B2), administration date 19Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, UNKNOWN MANUFACTURER), for Covid-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Bad pain from forearm to her hand".  Additional information: It was reported that, the patient received second dose of the Pfizer covid vaccine 3 weeks ago on 19Mar and since then she had been having until today really bad pain from forearm to her hand. The patient wanted to report it and know what can she do about it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Nausea immediately following injection that continued for 24 hours, Stoke like symptoms that began six hours after injection  that persist currently (48 hours +) including severe headache (resolved after 24 hours with 800mg ibuprofen Q3, Benadryl 25mg Q3 ), confusion, cognitive impairment, vision changes (L), drift in the upper extremity (L), dizziness, lack of coordination, and difficulty with depth perception. Neck stiffness from 12 hours post injection to 48 hours post injection. Negative for fever, vomiting, hemiparesis, difficulty with speech or word finding, facial droop,
Chest pain and palpitations began intermittently on 10/5, worsening into 10/7 and patient came to ER.  No shortness of breath or leg edema.
Numbness and tingling in left foot, full body rash, itching, fatigue, sore joints, fever. Given prednisone.
calling for temperature evaluation for VARIVAX and notifed it was administered to multiple patients; This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 29-APR-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX)(strength, dosing schedule, lot#, expiration date and route of administration were not provided) for prophylaxis. Administered dose of vaccine was exposed to the temperature from -14 Celsius degrees to -10 Celsius degrees for 4 hours 15 minutes. There was a previous temperature excursion noted: from -9 Celsius degrees to 8 Celsius degrees for 2 hours 21 minutes, as recorded by a digital data logger.  This is one of multiple reports from the same reporter.; Sender's Comments:  US-009507513-2007USA003458: US-009507513-2007USA004416:
Hepatitis B 40mcg administered to the patient in lew of Hepatitis B 20mcg. No adverse reaction at time of administration. Received report from supervisor that the patient verbalized complaints of adverse reaction following disclosure of medication error.
Patient had shingles like rash that itched. Saw primary care doctor was treated and doing well.