chrisvoncsefalvay/vaers-outcomes huggingface dataset:
an 8 year-old patient  received FLUBLOK QUADRIVALENT with no adverse event; Initial information regarding this unsolicited valid non-serious case via agency (reference number: 00337219) was received from other health care professional and transmitted to Sanofi 29-Oct-2020.  This case involved a 8 years old patient of unknown demoghraphics who was vaccinated  with INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot: QFAA2010; expiry date: 30-Jun-2021) via unknown route in the left deltoid for prophylactic vaccination (product administered to patient of inappropriate age).  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  It was a case of actual medication error due to inappropriate age at vaccine administration.  At the time of report, patient had not experienced any adverse events.  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.; Sender's Comments:  US-SA-2020SA306627:8 years old patient US-SA-2020SA306627:8 years old patient
Death Narrative:  Death on 03/04/21. 2nd dose of the vaccine was given 2 months before severe event. There is no indication that death was related to the vaccine. Patient was admitted to facility for hospice care when he passed.
Bilateral rash, from knees to ankles, flat, reddened, non-itchy, 4" long, multiple patches.  No known exposures.
Patient developed fever of 100.5 and a papular rash on the face and upper chest on 04/23/2022. The rash worsened over the weekend and by the time he was seen in the office on Monday had become more confluent especially on his cheeks and chest. no vesicles. No crusting or drainage. No urticaria. No wheezing or respiratory distress. continued low grade fevers that did respond to antipyretics but would return. He was more tired than usual but no Koplic spots, conjunctivitis, or lymphadenopathy.  there were no meningeal signs at the time seen in the office. Course of the antibiotic was completed on the day before the onset of the rash per mom. He did receive the Hepatitis A and Prevnar 13 vaccine on 04/22/2022. Rash is consistent with Measles rash or possibly allergic reaction although not likely. Was NOT consistent with parvovirus B19 or Enteroviral rash
After patient received the vaccine about 15 minutes after getting it she started to throw up. I took her B/P which was 144/90 and pulse 100. An ambulance was called she was taken to Medical Center.
Could not move my arm, pain in arm for 2 weeks after shots. Pain went from arm up my neck to my head. Did not feel well for at least 4 weeks, Shot was given too high on my arm.
Sore arm at injection site on 01-14-21 Arm pain worsened, fatigue, sore back, muscle pain in back 01-15-21 Developed small rash on right side of stomach 01-17-21 Rash was inflamed, and noticed two more patches of rash 01-18-21 8:30am MST Made a virtual health visit with Presbyterian Health Services 01-18-21 10:00 am MST Diagnosed with Shingles 01-18-21 10:30 am MST Noticed some pain when taking deep breathes at the site of the rash.  Prescribed Acyclovir 800MG 5 times/day for 7 days (Took three pills) Noticed more rash appear along the side of the stomach towards the back. Rash is itchy and hot. 01-18-21 7:00pm MST  Using Hydrocortisone for the itchiness as needed.
Patient less than 18 years of age received the 1st dose of Moderna's Covid-19 Vaccine. Parent present, educated, and gave consent.
Per patient's verbal report, a few hours after receiving the influenza vaccine, he "lost all hearing in [his] right ear and about 10% in the left ear." I was no longer present when the adverse reaction began. He quickly sought medication attention from his primary provider but was later referred to an ear/nose/throat specialist. He states he has had two rounds of prednisone treatment (dosage unknown), the first which was a 4-day course, and he has still not seen any improvement so far. He states he has never had an adverse reaction to the influenza vaccine and has received it several times.
Pt woke up at 2am freezing, she was vomiting, neck pain, chills, and cold sweats.
Patient went for an MRI 3 days after receiving her influenza and PREVNAR 13 vaccinations both in her right arm. The MRI read enlarged lymph nodes under the arm on the right side.
Fever on Sunday 5/15/16 and rash started 5/16/16 on feet and legs and then 5/17/16 on hands and arms.
Approximately 30 minutes after I received the vaccine I felt like my nose was stuffy, even though it had not been before I was given the vaccine. It felt as if I had a bad cold and I could not get air through my nose at all. Shortly after, the roof of my mouth felt heavy and sore and I experienced some difficulty swallowing.  When I took a breath through my mouth, I felt like I had to cough a bit - as if there was something irritating my airway. I did not experience any trouble breathing through my mouth. I did start sneezing a bit also.  My husband was home and he stayed with me for about an hour, until my symptoms began to subside. I did not take Benadryl or anything similar. That night around 330 am I woke with hives on my torso, under my arms and in my groin area. I did take  Benadryl that time so I could sleep.
There was no place to enter the date of the two above vaccines. The 1st 1 was on 2-22-2021, the 2nd dose was on 3-13-2021. On April 17th, I started to have Covid-19  symptoms: runny nose, headache, exhaustion. On the 2nd day, body aches, congestion, headaches, exhaustion. On the third day, all symptoms continue and I lost my sense of smell and taste.  No fever ever. On the 4th and 5th day, a runny nose has stopped. all other symptoms continue.
At time of vaccination, I was 21weeks2days pregnant. EDD is 3.8.2022 AEs: 1) 10/27/21: intermittent sharp, short chest pain (over heart) lasting a few seconds per episode; started within 1.5 hrs of vaccine, resolve by the next morning. No sob. 2) 10/28/21 - ongoing: swelling of all my fingers (this was common for me prior to becoming g pregnant d.t CREST syndrome, but had resolved during my pregnancy, only to be retriggered after the vaccination).
I received two doses of the vaccine plus the booster and I just tested positive for the Covid-19; I received two doses of the vaccine plus the booster and I just tested positive for the Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 46-year-old patient received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EL3247), on 18Mar2021 as dose 2, single (Lot number: EL3247) and on 22Nov2021 as dose 3 (booster), single (Lot number: EW0196) at the age of 45 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TRUVADA. The following information was reported: VACCINATION FAILURE (medically significant) with onset 23Jun2022, outcome "unknown", COVID-19 (medically significant) with onset 23Jun2022, outcome "not recovered" and all described as "I received two doses of the vaccine plus the booster and I just tested positive for the Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) negative, notes: "I do not lab test, I took home antigen test on Tuesday evening and it was negative and then I took another home antigen test today and it was positive."; (23Jun2022) positive, notes: "I do not lab test, I took home antigen test on Tuesday evening and it was negative and then I took another home antigen test today and it was positive.". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient reported that, patient took home antigen test on Tuesday evening and it was negative and then took another home antigen test today and it was positive. Patient also reported that, started taking just Niclo and Declo yesterday because patient thinks it was over because patient had the negative test on Tuesday but just re-tested and was positive.  No follow-up attempts are possible. No further information is expected.
pain in arm; trouble urinating; fever 101F; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in arm), URINE ANALYSIS ABNORMAL (trouble urinating) and PYREXIA (fever 101F) in a 64-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for Heart disease, unspecified, FINASTERIDE for Prostate cancer, MULTIVITAMINS [VITAMINS NOS], FISH OIL, VITAMIN C [ASCORBIC ACID] and MAGNESIUM for an unknown indication.    On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced PAIN IN EXTREMITY (pain in arm), URINE ANALYSIS ABNORMAL (trouble urinating) and PYREXIA (fever 101F). At the time of the report, PAIN IN EXTREMITY (pain in arm), URINE ANALYSIS ABNORMAL (trouble urinating) and PYREXIA (fever 101F) outcome was unknown. Not Provided
The pt complained of soreness, swelling and redness on left arm between elbow and upper arm the day after injections.
Information has been received from a certificated medical assistant referring to three patients of unknown age. On unspecified dates in February 2015 the patients were respectively vaccinated with a dose of VARIVAX (Merck) (dose, route and lot# unknown) that had been improperly stored. No adverse effects reported. Additional information has been requested.
Raised  red circular lump at the injection with left arm soreness. Treatment: Tylenol with improvement of soreness.  Outcome: Continue to work does not interfere with ADLs. Recommend to use OTC hydrocortisone cream.
Pneumonia; Sepsis; Lack of drug effect; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia) and SEPSIS (Sepsis) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-May-2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant), SEPSIS (Sepsis) (seriousness criterion medically significant) and DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, PNEUMONIA (Pneumonia), SEPSIS (Sepsis), DRUG INEFFECTIVE (Lack of drug effect) and COVID-19 (COVID-19) outcome was unknown.            No concomitant medication was not given.   No treatment information was provided.  On 2 May 2021, SARS-CoV2 test was performed, results not provided.  Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable. For the rest of the events: 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.; Sender's Comments: Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable. For the rest of the events: 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.
Pt vaccinated with DTP/OPV had several generalized seizures and was admitted to hosp.
Patient reports 2" diameter injection sight reaction that is erythematous. She is treating it with OTC hydrocortisone cream and seeing relief. She also reports diminished hair growth in a baseball-sized patch on the crown of her head.
Had redness to left deltoid the size of softball per mom and slight swelling. Mom requested to fill this out.
Patient presented to the ED and was subsequently hospitalized of symptomatic sinus bradycardia. She was diagnosed with Possible Mobitz type 2 second degree AV block.
Date of delivery reported 7 pounds 1 ounce. Late July I went into early labor and my inhaler wasn't working and I couldn't breath so I went to the emergency department. They were able to stop labor. On December 12, 2022, I was nauseous and throwing up and was sent home from work. I tested positive for COVID-19. December 14th, I visited the doctor and confirmed test results. I was prescribed PAXLOVID for 5 days. My symptoms are cough, headache, fatigue, diarrhea, loss of taste and smell, and trouble breathing. I also had a fever for a couple of days and was freezing cold and burning hot. I still have cough and headache and my chest hurts when I breath.
Fluarix - which is not indicated for peds patient <18 year old was administered by mistake medical assistant.
Head ache, body aches, chills, nausea beginning in the early hours the following day.
Patient received the COVID-19 Pfizer vaccine at 08:41 am on 2/28/2021. Patient began to experience tongue swelling and her throat tightening. At 9:35 AM, Diphenhydramine 50mg IM Injection was given in the Right deltoid. Diphenhydramine lot number 6124005, EXP 04/22. At 9:48 AM, Patient continued to sound and feel throat raspy and coughing,  patient was given an Epi pen into her right thigh. Epi pen lot number 0FM501, EXP 05/22. Patient was also given Solu-Medrol 40mg injection into the right glute at 10:30AM. Solu-Medrol lot number DP2618, EXP 01/22.
It started with a very runny nose and sinus congestion. I tested and I was positive. I called the doctor's office and they prescribed PAXLOVID. The next day I felt very severe flu symptoms. Body aches and temperature of 101.5 degrees. As soon as I started taking the PAXLOVID the symptoms were not as severe. I took it for five days. The very bad symptoms had lessened but I was still very tired and weak. After about 10 days I wore a mask for two weeks. I had to build my strength back up. I was very weak. Now I do not have any symptoms.
Injection was administered as part of this organization's mandatory flu vaccination program. Injection was administered by a CMA at this facility. Employee stated pain began immediately, and did not abate. Employee stated he was in the process of changing primary care physicians, and chose not to seek evaluation. He did not rest his arm, but chose to, 'work it out."  Employee described localized pain in the left shoulder that extended from the site of injection to perhaps two inches down his arm. Pain was irregular, and most noticeable when he bent his elbow or moved his arm or  to pick up an object.  He stated the pain was often so sharp and sudden, it made him drop things. Employee was seen by our organization's medical director, Dr. Upon examination, Dr. noted no induration, swelling, or tenderness to palpation. Dr. strongly advised employee to seek evaluation with his new primary care physician.  Dr. suggested an OTC anti-imflammatory (Aleve)  and further advised employee to rest his arm as much as possible. This RN maintained close contact with employee's progress, as he remained reticent to follow through with seeing his PCP. Employee continued to report steadily decreasing pain and eventual discontinuation of Aleve.
1.  Extreme Dizziness and Vertigo, 25 hours after inoculation.  I experience these symptoms often because of other medications and vestibular disorder.  Vertigo  lasted approx  36 hours.  I fell twice.  Once forward on my face and lower body.  No damage, other then bruise on leg and sore hands from trying to break the fall.  I was able to get myself up and assess no severe damage The other time when lowering myself onto the toilet. 2.  Sore arm at injection sight; I exercised arm to alleviate discomfort.  Lasted 36 hours.
no other adverse events reported; patient received an expired dose of GARDASIL 9; patient also had an interrupted schedule; This spontaneous report as received from a physician refers to a patient of unknown age. No information about medical history, concurrent conditions or concomitant therapy were provided regarding the patient.  On an unknown date in 2008, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (formulation, dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. On an unknown date in July 2021, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (formulation, dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis (Inappropriate schedule of product administration).   On 13-DEC-2021, the patient was vaccinated with an expired third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) pre-filled syringe, lot # S020255, expiration date 09-DEC-2021 (dose, site of administration, route of administration were not reported) for prophylaxis (Expired product administered).   No adverse events were reported (No adverse event).
Tinnitus much worse than before 2nd shot (or first). Very loud pulsing that is annoying when trying to sleep (3 weeks after 2nd shot there is no improvement in the tinnitus). No treatment yet.
Information has been received from a licensed practical nurse referring to unspecified multiple patients of unknown age and gender. on unknown date unspecified number of improperly stored M-M-R II (lot# reported as L036851, therapy type rHA, expiration date 23-SEP-2017) was given to the multiple unspecified patients. No adverse effects reported. The temperature excursion was 48 degree Fahrenheit for 24 hours, data logger was used. There was no prior excursion. The temperature was back in range at the time of reporting. This is one of several reports received from the same source. Additional information is not expected as there is no consent to contact the physician.
Starting at day one and lasting 36 hrs fever of 101  Starting on day one and continuing  through day three  large area of swelling redness and heat approximately  six inches around injection site
chills; fatigue; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 01Oct2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient). A 40 year old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 and dose 2 on unspecified date(s), batch/lot and expiries unknown, both as a single dose for COVID 19 immunization. Medical history and concomitant products were not reported. The patient had received his first dose as of 05Jan2021. The patient reported he experienced chills and fatigue with the first 2 doses. The outcome of the events was unknown. He subsequently received the 3rd dose/ booster of BNT162B2 on 28Sep2021.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.; Sender's Comments: Linked Report(s) : -PFIZER INC-202101301634 same patient, similar events with dose 3
she felt like she had the flu; This is a spontaneous report received from contactable reporter(s) (Pharmacist). The reporter is the patient.  A 49 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 18Mar2021 (Lot number: EP7534) at the age of 49 years as dose 1, 0.3 ml single for covid-19 immunisation. Relevant medical history included: "Fibromyalgia" (ongoing), notes: diagnosed 8 or 9 years ago; "chronic pain" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset Mar2021, outcome "unknown", described as "she felt like she had the flu". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: NDC number and Expiry Date of Pfizer Covid 19 Vaccine was Unknown. She took Pfizer Covid 19 Vaccine because she didn't want to die from COVID. Investigation Assessment was yes. Relatedness of first dose for event felt like she had the flu was related. Caller stated she had the Pfizer Covid vaccine back in the spring and then the second dose 08Apr2021, she had the booster Pfizer vaccine Monday afternoon, 11Oct2021, of this week, the first two times she had the  vaccine, the first week after the first one, she felt like she had the flu, she was sick for about 3 days after the second one. The other thing she should say, she takes a number of medications, she has chronic pain, she has fibromyalgia that they are treating, she doesn't know, they may think it may be some of the medications she takes and the vaccine, they didn't seem to know. She thinks she went to the doctor and they of course gave her a Covid test which was negative, they just said she would have to ride it out, in Mar2021. She has had Covid tests ongoing on and off throughout the pandemic and they all have  been negative.  No follow-up attempts are possible. No further information is expected.
I experienced achiness, tiredness, coughing, and loss my sense of smell for two days. I never ran a fever. I didn't get to see the doctor until Friday. I got on Paxlovid on Friday. I started feeling better after taking Paxlovid for a couple days.
pt recvd vax; devel enlarged lymph nodes of neck & low grade fever & rash
Pain and swelling at injection site. Redness to skin on full body and swelling of face. Pain to full body and joints. Low grade fever.
Breakthrough case admission after two vaccines  Pfizer 4/7/21 Lot# not recorded;  Pfizer 5/5/21 Lot# not recorded
Day after shots woke up and her RA was red, swollen and sore. In the afternoon of that day she was very tired and sleepy and in the evening had very bad HA.
Case number PHEH2015US026942, is an initial spontaneous report received from a nurse on 22 Dec 2015. This report refers to a 32 years old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501, expiry date: May 2016) into left deltoid on 09 Oct 2015. It was reported that before administration the FLUVIRIN had a temperature excursion of 34 degrees. The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day and the temperature was fine. It was a new refrigerator and there have not been any problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. No further information provided. Follow up information received from the nurse on 26 Jan 2016: Reporter's comment updated.
Father of the patient lied about the patient's age at time of vaccine administration to make child eligible to receive vaccine (said patient was was 12 years old when really was 10 years old). Spoke with the father regarding the incident on 5/12/21 after discovering the child's real age.
36hr p/vax 4 episodes of ?clonic activity inside of 10min;no fever w/irritability;asymptomatic next AM;
Red rash on both hands. Not itchy or burning, just there. The rash eventually went away. I never went to the dr as I read that that could be a side effect.