chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1st shot a year ago, missed 2 to 6 month window; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received a year ago of reporting date).   On an unknown date, the patient received 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 details were provided as follows: The age at vaccination was not applicable for this report. The patient self reported the case and mentioned that, he/she missed the 2 to 6 month window for the 2nd shot, which led  incomplete course of vaccination. The patient asked should he/she get the 2nd shot now.
Client received first dose of COVID-19 pfizer vaccine in left deltoid at 3:22 PM. Vaccinator activated the plunger on the vanish point syringe which made an unusual clicking sound. When vaccinator withdrew syringe from client's arm, the actual vaccine fluid out of the client's arm. Vaccinator believed there was less than 50% of the dose still in the client's arm as a lot of the vaccine squirted out of the client's arm. Vaccinator alerted me of the situation as I was the co-lead of the site. I then notified our clinical care coordinator that gave the CDC guidance of revaccinating the client today if there was less than 50% of the first attempt administered. Client along with parents were notified of the situation and client was in agreement of revaccination.
Expired Influenza given to patient. Expiration date of 6-30-21. No treatment given, no signs, symptoms, reactions.
Rash and hives from top of her head to her feet. Clinical diagnosis of anaphylaxis.
Patient received a dose from a vial that was not stored appropriately. The vial had been stored at room temp for about 2 weeks. My technician accidently drew up a dose from the bad vial rather than the good vial.
Swelling with yellowish blisters in (R) thigh - raised large erythematous patch - in thigh.
booster; swollen lymph node; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 16Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing), notes: Feb he was diagnosed with COVID-19; "Breathing issues" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose, Apr he received the Pfizer COVID -19 vaccine and he had minor issues of fever and chills), administration date: Apr2021, for Covid-19 immunization, reaction(s): "Chills", "Fever"; Bnt162b2 (Second dose), administration date: 2021, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 16Nov2021, outcome "unknown", described as "booster"; LYMPHADENOPATHY (non-serious) with onset Nov2021, outcome "unknown", described as "swollen lymph node".  Additional information: Call was transferred from Pfizer by (Withheld) (CEP-ID: 159558). Transferring agent stated, "I have a consumer on the line that is calling to report an adverse event and in Feb he was diagnosed with COVID-19 and he was having breathing issues with having the COVID and in Apr he received the Pfizer COVID -19 vaccine and he had minor issues of fever and chills he said it didn't last very long but he said that having the vaccine alleviated the breathing issue that he was having from having COVID and then two nights ago he received the booster dose and he said that he has the swollen lymph node that is about the size half a lemon." Product details (Expiration date, NDC# UPC#) Treatment and other details could not be probed as consumer was unwilling to share further information. Hence, Limited information available over the call.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
NauseaVomiting chills, low grade fever 99F, fatigue Narrative:
Tachycardia, beginning 12/29/20, or noted at time of awakening, heart rate of  68-161 beginning at 6am-7am. I watch documents rate on 12/29/20 from 7am resting rate 76, walking rate of 140.  This rate is not the normal as patient normally walks to work but this date chose to take a cab, rate of 140 not normal resting rate. Rate ranges 150-on 12/29-to 55-209 on 12/30/2020, resting rate of 66.  Walking rate of 103, Did not not exercise rest of the week because of this elevated rate.  Felt colder than normal.  One week prior rate was 12/22/2020. Range was 59-127, resting 62, walking 107.  Rate week of 1/5/2021 ranges 49-158, resting 55 and walking is 91. 1/8/2021 rate ranges from 54-145, resting 59, walking 100.
Expired vaccine administered  beyond 12 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered  beyond 12 hours post puncture) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered  beyond 12 hours post puncture). On 01-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered  beyond 12 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug information was provided.   This case was linked to MOD-2021-403910 (Patient Link).
Bilateral, severe, median mono-neuropathies with motor involvement, immediately following 1st dose; aggravated after 2nd dose. Decreased vibratory sensation both LE and flu-like symptoms.
No significant adverse reaction. Myalgia 2 hours to flu vaccine, local reaction. Fuce ROM.
Swollen tongue pins and needles in right arm and legs legs weak feeling very lathargic and weak
78 hours after injection I got dizzy and had fairly severe vertigo , nausea and threw up 4 times. I felt hot and chilled... I am not sure it was related to the injection. It resolved on sat Feb 20th 2021.  I still have mild nausea but am on Ozempic which gives me nausea some of the time. I did not feel well but finally fell asleep and slept until AM.
New-onset seizure. This was the first time this patient had seizure (slumped over while mom was braiding her hair - had fixed pupils and was unresponsive for 10-15 seconds). In taking history, she may have been having absence seizures in the past, but it is not entirely clear at the time of history taking.
Narrative: PER DEATH CERTIFICATE PT DIED FROM DEMENTIA AND ASPIRATION PNEUMONIA. Per chart review, this patients cause of death was not likely attributable to the COVID-19 vaccine
1/28/13 - Approx 2.5 x 1.5 in. raised red area with clear margins. Per pt - PCP started abx for cellulitis.
Diarrhea.  Severe stomach pain. inconsolable crying arching back.  hitting face. Sleeplessness. Restless.
Mom noticed red itchy spottty rash L upper arm this am. Tried 1% HTC x2 without relief. Incraesed redness and 'fels hard' in the area by afternoon.
Red mark 3-4 inches. Slight swelling. No pain or itching. Discovered during pt massage.
Patient reports exacerbating of lupus symptoms and dry eye since getting vaccination on december 17th, starting on december 20th and continuing until visit today on 1/6/2022. Patient reports worsened joint pain, kidney pain, low back pain, fatigue, cough, fever, mental fatigue, breathing, and dry eye.
Information has been received from a healthcare worker concerning a male patient who by the "end of February 2011" approximately 28-FEB-2011, was vaccinated with a dose of PNEUMOVAX 23 0.5 ml, intramuscularly in the arm (Lot number 667914/1067z, expiration date 29-FEB-2012). The health care worker reported that by the "end of February 2011" one day after the patient got the vaccine, the patient's arm became red and warm after receiving vaccine and he developed a bump that was hard to the touch, the bump was the size of a quarter. Patient sought unspecified medical attention. Laboratory diagnostics were not performed. The patient recovered "within 3 to 5 days after reporting event". This is one of five reports received from the same source. Additional information has been requested.
pt recvd vax & 3 days p/vax exp dizziness, perforated tympanic membrane, a cold, viral synd; MD feels that the cause of pt's dizziness is probably viral synd;
Covid19 breakthrough.  Vaccine received on 05/28/2021.  72 y/o female with PMHx COPD, HTN, Parkinson's, CVA, AFib, HLD, Anxiety, Dementia, GERD, Lung lobectomy was initially admitted to a HCF with Right sided weakness.  MRI showed acute Left MCA infarction.  Pt was transferred to an Inpatient Rehab on 04/22/2022.  On 04/23/2022, pt c/o cough, congestion, chills and started having Temps. Room air sats 95%.  CXR-emphysema.  Pt started on steroids.
pt recv vax & exp numbness in lt arm along top portion from deltoid down arm to wrist & hand;numbness located in deep center of arm & in anterior arm;during 3rd wk post dose 1 had pain which lasted 1-2wk;
For about one month after I had the vaccine, I experienced weekly episodes of sudden onset severe diarrhea with nausea and dizziness to the point of almost passing out. The dates of these events (which mostly occurred in the middle of the night and caused me to stay home from work the following day) were: June 6, June 13, June 22, July 3. On June 22 I had 6 episodes of diarrhea throughout the night, with nausea and dizziness. One July 3, I had 5 episodes of diarrhea from 5:30-7:30 a.m., also including nausea and dizziness. Also during that month I suffered from severe muscle pain, fatigue and general feeling of malaise.
Mild events began at 11:30-12:00pm : Symptoms included soreness on injection site and redness; tiredness, lightheaded and wooziness. Severe events began at 3:30-4:00pm : Symptoms included cellulitis on injection site that last trough the week. Tiredness, lightheaded and wooziness increased until early morning with symptoms of extra heavy tiredness and lightheaded, wooziness and brain fog. My personal opinion is that it was some kind related to T cells, which are related to celiaq disease overactive response with gluten  or crosscontamination intoxication. Severe events began slowing down until fully dissapeared on the 3rd day after 2ndo dose.
Pt comes in 9-29-11 evening 830pm & informs me. "The worst flu shot I ever had & I have had a lot of them." Pt started flushing/feverish. Worst joint aches ever couldn't move or get out of bed for 1 1/2 days.
Soreness in arm.; Could not lift or engage arm muscle without pain.; Lethargy.; Overall fatigue; Pain in legs; Pain in back.; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the right arm on 25Mar2021 at 16:00 (at the age of 55-years-old) as single for COVID-19 immunisation. The patient had no known medical history and concomitant medication. The patient had no known allergies to medications, food or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 04Mar2021 at 16:00 (at the age of 55-years-old) as single for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 25Mar2021 at 20:00, the patient experienced soreness in arm and was not able to lift or engage the muscle arm without pain. The patient also experienced overall fatigue, lethargy, pain in legs and back which was not sharp but just uncomfortable on 25Mar2021 at 20:00. The patient did not receive any treatment for the events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcomes of the events soreness in arm, not able to engage muscle arm without pain, overall fatigue, lethargy, pain in legs and back pain were resolving. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Moderna COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Moderna Vaccines on 2/2/2021 and 3/2/2021. Presented on 10/13/21 with dyspnea and hypoxia. Diagnosed with acute/chronic CHF, anemia and COVID pneumonia. Aggressively managed but failed to respond. Family opted for comfort care rather than continued aggressive management and she was admitted to hospice for end of life care.
Received monoclonal antibodies on 12/6 Patient admitted on 12/11/21 for hyperkalemia, elevated troponin  Severe mitral and tricuspid regurgitation ischemic cardiomyopathy with CHF   Shes also recently been admitted from 12/6 - 12/9 AMS, COVID19, Encephalopathy, ESRD , had reported diarrhea for past several days and vomiting
Pt admit to hospital with COVID 6/15/22 (1st positive test on 6/13/22 - given molnupiravir OP). Pt previously received 3 doses Moderna on 1/22/21, 2/19/21, 12/28/21.
Over the course of 5 months, I have gradually been having very extreme fatigue like I am being weighted down. I have bouts of crying, brain fog and headaches.  Each and every day, since around November, the fatigue has gotten worse, to the point now where it feels like I am dragging a ton of lead behind me and it is dragging me down.  It is very hard to explain, but it is overwhelming.   You are supposed to wake up in the morning feeling refreshed, but I don't.  I wake up feeling very, very tired.  I also have problems with my walking, like I am going to stumble.
As soon as the needle was inserted into patient Left arm she "passed out" she has s/s of vasovagal response. She was unresponsive for about 20 seconds once conscious again she was hot, clammy, sweating, nauseous, and dizzy. Vitals taken low BP noted patient was given water at her request and a cool towel applied to the back of her neck.  Vitals taken at 5 minutes after episode BP noted to be WNL. Patient then reported that she had "passed out" before during vaccination.  after sitting and recovering for 20 minutes the patient left our facility in the care of a family member.
This case was reported by a consumer via call center representative and described the occurrence of white blood cell increased in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. On 30th November 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 2nd December 2021, 2 days after receiving Shingrix, the patient experienced white blood cell increased. On an unknown date, the outcome of the white blood cell increased was unknown. It was unknown if the reporter considered the white blood cell increased to be related to Shingrix. Additional details provided were as follows: The patient self-reported the case. The patient received a dose of Shingrix and had a routine complete blood count laboratory blood test done which showed elevated white blood cells, it was unknown if patient recovered. He had nothing else to report. The reporter consented to follow-up.
Pain in the inside of the elbow, upper arm where shot was in left arm, shoulder and neck. I went to the Doctor on 1/9/2016 and they gave me prednisone for 3 days and then had me ice the arm and shoulder. I also had trouble eating eggs and weakness in my left hand. Pain did not go away so Dr referred me to another Dr for Nerve Testing. I also started Physical Therapy for 6 weeks. On February 20th as the pain was still there they did a Vascular Ultrasound. The symptoms are still there and I have continual Pain in my left arm, shoulder and neck.
This spontaneous report as received from a certified medical assistant (C.M.A.) refers to a 17 years old patient of an unknown gender. The patient's medical history and concurrent conditions were not reported. On 26-MAY-2015, the patient was vaccinated with a dose of VAQTA (lot # K007791, expiration date 22-AUG-2016, dose, frequency and route of administration were not reported), which was exposed to temperatures outside of the recommended range. No adverse effect was observed or reported. Product quality complaint (PQC) was not involved. This is one of several reports from the same reporter. Additional information has been requested.
FluBlok was at 8.4 C for more than 24 hrs, patient did received this FluBlok that was out of range, no AE; Initial information received on 20-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff).  This case is linked to 2019SA267191; 2019SA267208 ; 2019SA267209; 2019SA267210; 2019SA267211; 2019SA267212; 2019SA267213; 2019SA267214; 2019SA267215; 2019SA267216; 2019SA267217; 2019SA267218; 2019SA267219; 2019SA267220; 2019SA267221; 2019SA267222; 2019SA267223; 2019SA267224; 2019SA267226; 2019SA267227; 2019SA267228; 2019SA267229; 2019SA267230; 2019SA267231; 2019SA267232; 2019SA265193.  This case involves a male patient of unknown age who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV], lot QFAA1911, exp date: 27-JUN-2020  via intramuscular route in the left deltoid on an unspecified date which was at 8.4 Degree C for more than 24 hrs and patient did received this flublok that was out of range.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   No Concomitant vaccine given.  It was a case of actual medication error due to incorrect product storage.  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 holders compliance with the requirements set out in Directiveand Module VI of the 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.  Documents held by sender: none.
Legs, neck, arms and chest ache...headache...fever..chills..felt like I got hit by a bus. Most of the day..Tylenol and Ib would help some of the symptoms. Lasted almost 24 hours.
Patient was given MENACTRA and should have had Meningitis B vaccine. No symptoms.
DECREASE MOBILITY IN SHOULDER; UNABLE TO WORK; DEPRESSED; SEVERE SHOULDER PAIN; This spontaneous report received from a consumer concerned a 66 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient was in good health. patient had undergo physical therapy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown expiry: UNKNOWN) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 2021, the subject experienced decrease mobility in shoulder. On 2021, the subject experienced unable to work. On 2021, the subject experienced depressed. On 2021, the subject experienced severe shoulder pain. Treatment medications (dates unspecified) included: ibuprofen, paracetamol, cortisone, prednisone, and hydrocodone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe shoulder pain, decrease mobility in shoulder, unable to work and depressed was not reported. This report was non-serious.
Varicella vaccine breakthrough. Started with itchy rash on 12/11/2005. No fever. Seen in our office on 12/12/05 and diagnosed by Dr with varicella. had 20-30 scattered papules on trunk and extremities, some with scabs. Vaccine given on 07/17/2000.
Headache; body aches; Fever; This is a spontaneous report from a contactable consumer.  A patient of unspecified age and gender received bnt162b2 (BNT162B2) , via an unspecified route of administration from an unspecified date, as a single dose for COVID-19 immunization. Medical history included had Covid last spring with severe symptoms. Concomitant medications were not reported.  The patient reported that  "I still was very tired from COVID. I felt less tired after first Pfizer vaccine. I had headache fever and body aches after second one and now have even more energy. The outcome of the events was unknown.  Information regarding lot number has been request.
Her menstrual cycle is abnormal, heavier bleeding than usual, has been going on for 8 days which is also longer than normal for her cycle.
Called Dr at 2:00 AM on 7/19/05, pt had fever of 104.2F. Went to ER. Cath in ER-UTI and was given Ampicillin. Also states, crying and fussiness. Tylenol 7/19 at 09:30-in office at 10:30 AM. Dr's office called HD.
leg calf muscle aches, headache, nausea, chills, low grade fever....for 24 hours...headache lasted two days
Within 1 hour of receiving the 1st of 2 vaccine doses my mouth became extremely dry; Extremely thirsty; Suffered from a mild headache; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613), via an unspecified route of administration on left arm 20Mar2021 at 12:15 (at the age of 60-years-old), as a single dose for COVID-19 immunisation. The patient medical history included colon issues. The patient had allergies which included codeine, cipro and flu meds. The patient did not receive any medication within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 20Mar2021 at 13:30 the patient reported her mouth became extremely dry and extremely thirsty within 1 hour of receiving the first of 2 vaccine doses. Patient did not get enough to drink. Later on the same day patient suffered from a mild headache and nausea. Therapeutic measures were not taken as a result of the events. The outcome of the events mouth became extremely dry, extremely thirsty, mild headache and nausea were recovered on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.