chrisvoncsefalvay/vaers-outcomes huggingface dataset:
red reaction 4x7 1/2cm on lt arm @ DTP inj site;
lt thigh red, edematous 4" x 3" APAP & DPH;
I got the vaccine in my right shoulder, the morning after I woke up and my hip was very sore and throbbing. When I got out of bed and stood up it became a sharp pain. I took I.B Profurien but it did not help. The throbbing is still going on today and I am a little worried because I got the shot in my shoulder not my hip.
At 11:00, pt complained of "not feeling right", was pale, diaphoretic, (red) rash beginning to appear on chest and neck. Also, pt complained of shortness of breath. At 11:01, laid pt in prone position and administered Benadryl 50mg, IM and Epi 1:10000, 0.3ml, SQ. Given O2 via NC. Vital signs: HR 70, BP 108/58; RR 20. Pt transported to ER via EMS.
Shingles/Suspected vaccination failure; Shingles all over my back; Went to a visit at Hospital for my kidney; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and renal disorder. On an unknown date, the outcome of the vaccination failure, shingles and renal disorder were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and renal disorder to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 08-Aug-2022 Reporter's Comments: The patient self-reported this case via interactive digital media. The patient was vaccinated and got the shingles. The patient never felt one thing and stated that he/she was blessed he/she did not even realize he/she had them all over the back until he/she went to a visit at hospital for the kidney and they flipped out and said the patient had shingles. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not be possible as no contact details were available.
When I got the second dosage, I was already on my period (my period lasts for seven days, and I was on day 5 of 7). After I got the dosage, I noticed that I was still on my period (as I am typing this, I am currently still on my period?almost coming up on 3 weeks?which is not normal at all). I also noticed that I developed a twitch in my left eye a few days after getting injected, and that?s been around for 2 weeks.
At about 6PM, Wednesday, October 6, he began with shaking chills that lasted for at least 30 minutes.  He was tired and sent to bed at 8PM, body aches continued to next morning with tiredness and slept all day.  After about 24 hours, ate evening meal around 5:30 and felt good.  Felt fine for rest of evening and feels fine today, October 8th.
Swelling of lips, nose and ears w/nausea. Treated at Urgent Care w/prednisone.
Discharge Provider:  MD Primary Care Provider: DO Admission Date: 9/6/2022 Discharge Date: Sep 7, 2022  PRESENTING PROBLEM: Weakness  COVID-19 virus infection  COVID-19    HOSPITAL COURSE: Patient is a 87 y.o. female with atrial fibrillation, coronary artery disease status post CABG, hypertension, iron deficiency anemia, diastolic CHF, pulmonary hypertension, type 2 diabetes, hyperlipidemia, history of GI bleeding, CKD 3 and asthma who presented with chest discomfort associated with shortness of breath and slight cough starting four days prior to arrival.     Significant workup in the ED included COVID 19 positive test. She was not requiring any supplemental oxygen in the ED. Family expressed concerns about increased care for her at this time so she was admitted for therapy evaluation and possible placement in deemed necessary. PT/OT recommended home with assist and patient was discharged home in stable condition under the care of her daughter.
no other AE; received a dose of VARlVAX after the product was improperly stored; This spontaneous report refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 05-MAR-2021, the patient was vaccinated with dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) 1 dose, lot # T006347, expiration date: 20-FEB-2022 (formulation, strength and exact dose were not reported) for prophylaxis. On an unknown date, the dose of the vaccine was exposed to temperature excursion at -6.6 Celsius degrees (C) for 59 minutes. There was no previous temperature reported. The call was due to digital data logger. No additional adverse event was reported.
Patient received Moderna Covid vaccine and during 15-minute monitoring period she called me over to discuss skin rash developing on both arms. Upon observation she was sweating and slightly tachycardic. Administered 25mg oral Benadryl and skin reaction went down as well as sweating ceased. Did not check heart rate again due to other improvements. She returned to work and will take more Benadryl if needed.
Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Patient had the flu and pneumonia shots on 11/3/17 around 2:05pm. Later that evening the patient was experiencing nausea, chills, and a fever of 101.1 F (which lasted for a few days). In addition to the discomfort that evening, the patient went into the kitchen to take her night time medications and noticed a "wooshing" noise in her right ear then noticed she could no longer hear out of that ear. The patient then had an audiology exam done by her ENT, which confirmed the hearing loss in the right ear. ENT has referred her for an MRI of the head to ensure no mini stroke or other neurologic issues, which she has scheduled to be completed.
low grad sinus infect- bactrim dx by PMD;fluid in rt ear;not watching diet good;stated sore next day post flu vax not too bad post 4 days flu shot gradually got worse;woke up in morning worse but would get better w/hot shower;cant lift arm
Patient 49-year-old female with history of asthma that presented with complaints of chest pain.  She states that she went to get her Covid booster shot this afternoon.  A few minutes after receiving the vaccination she began to feel left-sided chest pressure as 8 out of 10 in intensity.  States that she does have radiation of her pain down her left arm which she describes as numbness/tingling.  she also complains of chills, nausea, generalized weakness and shortness of breath.  She states that she got a dose of aspirin at the tent where she received her Covid vaccine after she became symptomatic.  She states that she got the Pfizer booster vaccination.  Denies complication with the previous 2 doses that she received which were also Pfizer.  Patient does mention that she previously had chest pain in the past where she had a cardiac work-up with heart house including EKG, 2D echo, exercise stress test that were all normal.
Flu like symptoms (x 2 wks) myalgia, arthralgia fatigue. Myalgia/arthralgia hands, feet, ankle, knees elbows. Also had lightheaded but no vertigo. Rare HA. Abd pain but this preceded vaccine. Ibuprofen/Aleve
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 36-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 040B21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]), DOCOSAHEXAENOIC ACID (DHA) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 25-Dec-2020 and the estimated date of delivery was 01-Oct-2021. On 25-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twelfth week of the pregnancy.  On 23-Apr-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Jan-2021, Pregnancy test: positive (Positive) Positive. On 16-Mar-2021, Full blood count: normal (normal) normal. On 16-Mar-2021, Ultrasound antenatal screen: normal (normal) Everything is cleared; baby healthy. On 11-May-2021, Ultrasound antenatal screen: normal (normal) normal.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.
Seriousness criteria other medically significant (OMIC). Initial report received on 10/24/06 from a health care professional. A 10 month old male pt, with no current illnesses, allergies, or past medical history, but who was taking either Zantac or Prevacid (reporter was unsure), had received a first 0.25ml dose, left thigh, IM injection of Fluzone, lot number U2168BA, on 10/20/06. Within 24 hours post immunization, the pt developed left sided facial drooping that would not elevate with smiling, and his left eye would not stay open. He was medically evaluated and diagnosed with Bells Palsy. Diagnostic and treatments received were not reported. The pt had previously received, 15 days prior to this vaccination, a third dose, right thigh IM injection of Hep B vaccine lot number AHBVB301A, on 10/5/06. At the time of this report, the pt had not recovered.
Patient came in for his first dose of the COVID 19 Pfizer vaccine. After administering the vaccine the patient went to get a bottle of water and fainted while on line to pay for the drink. He got up and then fainted again. We sat the patient down and he was going in and out of consciousness of couple of more time. We called 911 and patient refused to go to the emergency room.
Case number PHEH2013US024193 is an initial spontaneous report received from a consumer via a claim examiner on 18 Nov 2013: This report refers to a 16-year-old female patient. She was vaccinated with FLUCELVAX, (batch number: 0040011A and expiry date: Jun 2014) on 11 Oct 2013 and experienced allergic reaction on an undetermined date. No further information about outcome, seriousness and causality was reported.
A report has been received from a Health Professional concerning a 26 year old, male subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on an unknown date. Health Professional reported that we accidentally administered FLUMIST to an employee who is HIV positive on 10-Oct-2014. The outcome of the event of accidentally administered FLUMIST to an employee who is HIV positive is unknown. The report was considered to be non-serious.
Initial information received on 26-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer/non-HCP (pharmacy student). This case involves an 80 years old patient (gender was not reported) who experienced bruising at the injection site, while he/she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient didn't have any other vaccines administered. On 20-Oct-2018, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported in the deltoid NOS. On an unknown date, the patient developed a non-serious bruising at the injection site following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. No lab data reported. Final diagnosis was bruising at the injection site. It was not reported if the patient received a corrective treatment. The patient outcome is reported as unknown for bruising at the injection site.
Wheezing, coughing, hoarseness.  Sought medical attention 10/28/09 as condition worsened.  She was cyanotic and O2 sats were 84%.  Given breathing treatments and placed on prednisone taper.
Breakthrough case admission after 3 vaccines Moderna 2/18/21 lot# 004M20A;  Moderna 3/18/21 Lot# 004M20A; Moderna 11/15/21 Lot# 004F21A
Fever, chills, body aches. Tested positive for COVID-19 after being vaccinated.
Pain and lump at injection site; headache, chills and fever; overall muscle ache.
1st dose 21Nov2019, 2nd not yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 21st November 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date : 23 Jan 2023 Reporters comment: The case was reported by the pharmacist. The pharmacist reported that the patient was not immunocompromised who received Shingrix first dose on 2019 and they want to administer a second dose. Additional supportive information: Till the time of reporting the patient did not received the 2nd dose of Shingrix vaccine which led to incomplete course of vaccination. Reporter did not consented to follow up.
Large hive developed at injection (DTaP) site within a few minutes of administration. Benadryl 1 tsp given. Observed in office 1/2 hour before discharge.
This case was reported by a nurse via call center representative and described the occurrence of itchy upper limbs in a female patient who received dTpa vaccine for prophylaxis. On an unknown date, the patient received dTpa vaccine at an unknown dose. On an unknown date, unknown after receiving dTpa vaccine, the patient experienced itchy upper limbs. On an unknown date, the outcome of the itchy upper limbs was unknown. It was unknown if the reporter considered the itchy upper limbs to be related to dTpa vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient received Tdap vaccine and developed itchiness on her arm. She would like to know if your product contain a common preservative Dodecyl gallate, which was also known as Dodecyl 3,4,5-Trihydroxybenzoate, Dodecyl ester of gallicacid, E312, Lauryl gallate.
Area lateral aspect of left arm, swollen tender erythematous (marked) not circumferential. Report day after inject given.
Inflammation/inflammation in the face and fingers/ hands were inflamed/ her arms, heart and mouth are still inflamed; Palpitations in the heart/heart is thumping; Dizzy; She had pain in her heart/chest pain; Had swelling in the face, arms, and fingers; Had swelling in the face, arms, and fingers; Pain; This is a spontaneous report from a contactable consumer (patient herself).  This 74-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown), via an unspecified route of administration, on 09Sep2021 (at the age of 74-year-old) at single dose for COVID-19 immunisation. Historical vaccine includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown), administered on 08Aug2021 at single dose for COVID-19 immunisation and developed palpitations in the heart/her heart was thumping so hard. No relevant medical history and concomitant medications were provided. On 09Sep2021, a couple of minutes after second dose, she had a reaction where her face was inflamed, and her fingers and hands were inflamed. In Sep2021, after the second dose, she had swelling in the face, arms, and fingers. She went to the hospital and was given naproxen to reduce pain and inflammation. They checked her heart and everything was fine. She presented chest pain, palpitations in the heart/heart is thumping, inflammation in the face and fingers. She went to the hospital again and she was told that everything was normal and there was nothing to do. The patient asked how long will take to the symptoms leave her body. She stated her heart was thumping and she had pain in her heart and was dizzy; she stated her face feels inflammation and her arms and fingers feel inflammation and she went to the hospital to check her heart and face and they did not find anything; she stated that was why she went into the hospital two times and it was for this same problem; she stated everything they check was ok and they checked her heart on a machine; she stated she had the same symptoms yesterday in the shower and she has had the symptoms for 14 days already; she stated she wanted to know what to do about those things and how will the symptoms go away in her body and she went to the hospital and they did not find anything and her arms, heart and mouth were still inflamed; the patient asked what to do to get this to go away and was aware that Pfizer unable to offer treatment recommendations or medical advice. The events were reported serious per hospitalization. The patient had not recovered from the events.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101258765 same patient, different event, different dose (first dose) of vaccine
Rash starting in armpits and spreading to body very itchy fading within 24 hours fine red rash.
Pt. received injection to (R) deltoid. Within 10-15 minutes, started breaking out in raised, itchy, red rash over trunk and extremities. NO SOB. BENADRYL 50 mg IM given. Within 5-10 min rash almost completely resolved.
High blood pressure  Pain in injection site  Light headed Fatigue  Headache Body aches Shaking
Extreme simultaneous vomiting and diarrhea for two long hours!!!!  I will not get another flu shot ever!
Fever to 103.7F, respiratory rate 36. Was transferred from facility to hospital. Since then has been found to have gram-negative rod bacteremia, although urinalysis was negative, urine culture pending. Patient has since defervesced after receiving 1 dose of cefepime. Overall the most likely cause of fever seems to be urosepsis w/ bacteremia, pending confirmation with urine & blood cultures.
Itching  on both elbows (outside) and discolored  area near/above itching area on right elbow. On day 9, discoloration and itch at/around injection site. Itching alleviated with hydrocortisone cream 1% topically applied.
No adverse event; 1 patient was accidentally administered 1st dose of and expired Moderna Primary Vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 patient was accidentally administered 1st dose of and expired Moderna Primary Vaccine) and NO ADVERSE EVENT (No adverse event) in a 23-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 044c22a) for COVID-19 prophylaxis.     The patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 14-Apr-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 14-Apr-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (1 patient was accidentally administered 1st dose of and expired Moderna Primary Vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1 patient was accidentally administered 1st dose of and expired Moderna Primary Vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (1 patient was accidentally administered 1st dose of and expired Moderna Primary Vaccine).    No concomitant medications were provided. No adverse events were reported by the patient after the administration.  No treatment medication was provided.
This case was reported by a healthcare professional and described the occurrence of inappropriate dose of drug administered in a subject of unspecified age and gender who was vaccinated with hepatitis B vaccine recombinant (ENGERIX B, GlaxoSmithKline) for prophylaxis. On an unspecified date the subject received 4th dose of ENGERIX B (10 mcg, unknown). Four doses of pediatric ENGERIX B were being administered to this dialysis subject to equal the 40 mcg dose indicated. This was considered to be an inappropriate dose of drug administered. One dose of ENGERIX B at 40 mcg should have been administered. The subject was also tested on an unspecified date and found to be hepatitis B antibody positive. At the time of reporting the outcome of the event was unspecified. This event has occurred in several subjects, number not specified. Follow-up information received on 16 June 2008 indicated that this report was not a true adverse event. Labs were drawn 24 hours after vaccine administration and the subject experienced a false positive result for hepatitis. At the time of reporting, the subject was negative for hepatitis B, verified with a lab redraw.
From Provider H&P: "Patient is a 55 year old woman who presented with dyspnea on exertion for one month that worsened acutely today.  Patient was admitted here in September with rapid atrial fibrillation and started on metoprolol XL 100 mg daily.  She was rate controlled on discharge.  Today she did not take her metoprolol before arriving here for work and was so short of breath she could not walk so presented to the ED where her HR was in the 140's.  She was given IV metoprolol without improvement and has been started on a diltiazem drip with improvement in HR to around 110.  Patient reports she is also aching all over and believes that is due to her second COVID vaccination that she received yesterday.  Her labs are at baseline today.  She is being admitted to the ICU on the diltiazem drip."
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender who on an unknown dates were administered an unspecified number of improperly stored doses of (Oka/Merck) VARIVAX (dose, route, lot # and expiration date were not provided). No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Starting the day after taking the 1st dose of the Pfizer COVID vaccine; I feel a lot of anxiety; rapid heart palpitations; prolonged exhaustion/tiredness, muscle/leg pain; arm soreness for the first 4 days.
anxiety; experienced transient burning type sensation in the chest; a fast heartbeat; This is a spontaneous report from a contactable other hcp. A male patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection), dose 2 via an unspecified route of administration on 24Jan2021 as SINGLE DOSE for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient experienced experienced transient burning type sensation in the chest and a fast heartbeat on 27Jan2021. Anxiety on 29Jan2021 at 15:30. The patient's lab tests included heart rate increased: a fast heartbeat on 27Jan2021. Outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Not an adverse event, but med error. pt requested Pfizer vaccine, but given J&J inadvertantly