chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe flu-like symptoms: joint and head aches, dizzyness and lightheadedness, weakness, chills, fever (100*F) Began suddenly about 12 hours after receiving vaccine, and ended abruptly 12 hours later.  Symptoms lingered to a small degree for another 24 hours or so.    Experienced drenching night sweats the night following severe reaction, that is, 36-44 hours after injection.  After that, all symptoms ended.
Patient?s mother presented  consent form  for Pfizer Kids on 11/10/2021 indicating the patient was 5 years old. The  nurse vaccinated the patient in error, not realizing the patient wouldn't turn 5 years old until 11/15/2021.  The nurse was informed a later date of this incident. Patient mother and  Manager informed of the incident.
After getting flu shot started having headache on 9/25/16 and continue to get worse through 9/27 with then vomiting starting to the point of dry heaves and then went into a seizure and was transported to hospital where another seizure took place and admitted for further observation.
"Shortly after" getting the second shot (absolutely no reaction to the first one) the arm broke out BELOW the injection site - nothing at the actual injection site. The patient describes the area to have looked as having looked like she had been stung by a LOT of bees or been punched in the arm repeatedly, very red to the point of looking bruised and with petechia. She states that she treated it with some over the counter hydrocortisone cream, which seemed to help. She presented to the pharmacy on 4/13 and showed me her arm and there was still some mild redness in a fairly large area below where the patient described the injection site to be; the patient says it is vastly improved over what it had been. The area was about the same size/general dimensions as an adult hand. She said she did run a low grade fever for a couple of days, but she had expected that.
This spontaneous report was received from a Licensed Practical Nurse referring to and unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. It was reported that, on unknown dates, the patients were vaccinated with an improperly stored dose of GARDASIL 9 for prophylaxis, reported lot # M037770 expiration date 01-JUN-2019 (dose and route were not reported). The administered doses of the vaccine experienced a temperature excursion of 0°C to 1°degrees Celsius for 4 hours 39 min. It was also reported that the vaccine experienced  previous excursions of  0°C to 1°degrees Celsius for 5 hours 23 minutes. The temperature excursions were detected by a data logger .There was no adverse effect reported.  No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1703USA012670: US-009507513-1703USA012672: US-009507513-1703USA007486:
This case was reported by a health professional on 22 August 2007. A 16-year-old male patient with no known medical history received an intramuscular left deltoid injection of Menactra (lot number U2393BA) on 20 August 2007. Immediately after receiving the injection, the patient became very pale, and lost consciousness for approximately two minutes. No intervention was required, and the patient recovered.
Pt recvd 1st dose of Hep B vax 14MAY91 & following vax pt exp vomiting, myalgia, & flu-like sx; these sx resolved over a period of several days;
Pt recvd vax & had temp 101 R; 12 hrs p/temp 103-104 R w/APAP having no effect;
Patient reported having vomiting, fever of 100.4F, aches, and chills. The symptoms started 9/3/22 a few hours following vaccination and resolved when reported on 9/6/22.
Case number PHEH2014US018194 is an initial spontaneous report received from a pharmacist on 09 Sep 2014. This report refers to an adult male patient who was in his twenties (20's). His medical history and concomitant medication were not reported. He was vaccinated with FLUVIRIN (batch number: not reported) subcutaneously approximately two weeks before reporting (no exact date provided). No adverse event was reported following this administration error (inappropriate route of vaccination).
C/O headache, shoulder pain, nausea for 3 days. (L) arm red, bruised, lump measures 21 x 25, (L) arm warm to touch.
Covid-19 vaccine administered 1/6/21. Injection site swelling, redness and itching started on 01/14/21. Seen in clinic on 1/15/21. 4x4 cm area of swelling and mild redness noted. DX: mild reaction allergy. Conservative treatment: Elevate arm. Apply warm compresses to the upper arm 4 times a dat 20 mins at a time. Return to clinic in five days for re-evaluation.
One day after my Moderna bivalent booster my gums started having extreme sensitivity and swelling. At first it was only the bottom left of my mouth but now has migrated to both the bottom left AND right. For now it is just minor pain and swelling, maybe a 3 out of 10.
This spontaneous report was received from a 74 year old male patient regarding himself. Patient's pertinent medical history and drug allergies was unknown. Patient's pertinent concurrent condition included high blood pressure and lymphocytic leukaemia. Concomitant therapies included mercaptopurine, clopidogrel and atorvastatin. On 26-FEB-2018, the patient was vaccinated with PNEUMOVAX 23, vaccine dose for vaccine for Pneumonia (route, lot#, expiry date were unknown). The patient experienced extreme fatigue, body aches, fever, and a loss of appetite approximately three hours after PNEUMOVAX 23 administration on 26-FEB-2018. On 09-MAR-2018, the patient was still experiencing the same symptoms and went to the Emergency Room. The patient was admitted on 09-MAR-2018, and released on 10-MAR-2018. The patient had unspecified tests done on the patient's lungs and head and the results were normal. The patient sought medical attention by visiting the physician and received unspecified treatment. Outcome of decreased appetite, pyrexia, pain and fatigue was reported as not recovered. The reporter causality of the event decreased appetite, pyrexia, pain and fatigue was not reported. Product quality complaint (PQC) was not involved.
Tired with the first one and spent more time sleeping; tired with the first one and spent more time sleeping; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (Tired with the first one and spent more time sleeping) and FATIGUE (tired with the first one and spent more time sleeping) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced HYPERSOMNIA (Tired with the first one and spent more time sleeping) and FATIGUE (tired with the first one and spent more time sleeping). At the time of the report, HYPERSOMNIA (Tired with the first one and spent more time sleeping) and FATIGUE (tired with the first one and spent more time sleeping) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Apr-2021, Blood cholesterol: 165 (Inconclusive) His cholesterol is 165. Annual physical exam result.. On 30-Apr-2021, Blood pressure measurement: high (High) High blood pressure Annual physical exam result.. On 30-Apr-2021, C-reactive protein: 0.6 (Inconclusive) 0.6 Annual physical exam result..     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.     This case was linked to MOD-2021-101049 (Patient Link).
Administration of vaccine past published expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past published expiry) in an adult female patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past published expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past published expiry) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Vaccines were administered to 19 patients on 29-Mar-2022, 30-Mar-2022, 31-Mar-2022, 01-APR-2022 and 04-APR-2022. Reportedly, 19 doses or Vials were initially stored in the refrigerator on 01-Apr-2022 and thawed on the day of use. The Vials did not undergo any temperature excursions. The doses were administered after 30-day Use By Date and after manufacturer date of expiry. The vaccine were thawed on the day of administration and administration was spread out throughout the end of March to the beginning of April. Treatment details were not reported by the reporter.
Expanding rash on 6/9, 8 X 12 cm rash left thigh.
Memory problems, concentration problems, brain burning, excruciating pain, lethargy. Heart problems or panic attacks.
For the past three weeks I have occasionally experienced heart palpitations.  I don't have any history of this and can't say for sure that it is related to the first vaccine dose, but it is a new development since then.
HEADACHES; This spontaneous report received from a patient concerned a 29 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 29-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-JUN-2021, the subject experienced headaches. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from headaches. This report was non-serious.
90 year old male came to pharmacy for refill of prednisone 20mg (3QD). Pharmacist #1 placed ZOSTAVAX recommendation card in his rx bag. Technician talked to patient about ZOSTAVAX and pt was interested in getting vaccine. Pt filled out questionnaire. Rx billing processed and Pharmacist #1 "checked"the RX (Pharmacist #1 did not notice the drug utilization review that was flagged by computer between ZOSTAVAX and prednisone, and he did not look at the patient's answers to vaccine questionnaire at all. Patient was rung up. Pharmacist #2 was then notified that a pt. was waiting for a shingles shot. Pharmacist #2 looked at questionnaire and read part way through it and stopped when noticing pt had checked "I don't know" when asked if he had a shingles shot in the past. Pharmacist #2 then checked online website to see if the vaccine had been administered previously (it had not). Pharmacist #2 forgot to loot at the pt's answers to rest of the questionnaire on the form. Pharmacist #2 did not notice the patient had checked "yes" on the last 2 questions asking if pt was on prednisone or immunosuppressants, and "yes" to if he had received blood transfusions or blood products or immunoglobulins in past year. Pharmacist #2 was also instructing pharmacy intern on how to mix the vaccine, how to administer. During conversation with patient, the patient mentioned he was on prednisone 40 to 60mg daily for 3+ months, but pharmacist #2 did not recall the contraindication between ZOSTAVAX and long-term steroid use. Vaccine was administered. During filing of paperwork, Pharmacist #2 noticed that she had not read the remainder of the questions on the questionnaire, and at the time read about the contraindication between the two products and called the patient, and the patient's physician. Physician prescribed valacyclovir for pr.
No ADR - Vaccine administration error with the Pfizer COVID-19 Vaccine made during preparation. Reporting based on guidance in EUA Factsheet for providers. During dilution, the incorrect diluent was used (Sterile water for injection instead of Sodium Chloride 0.9%) to prepare 2 vials of the vaccine. This error was caught by the checking pharmacist and no patients were administered the vaccine. The vials were discarded in a sharps container.
approx 3 days p/vax pt had reddened, warm, tender, swollen rxn;@ inj site site tx-symptomatically-referred to MD;
12/17/21 presents to ED for "flu-like symptoms". PMHx of "SLE, SVT s/p ablation (2010), asthma, pre-eclampsia, nephrolithiasis"
Flumist administered 10/12 half of dose in each nostril - 2nd nostril some swallowed by pt. Upper respiratory infection started 10/14 - mild rhinitis/congestion.  Early AM Tues 10/18 at 0100 nausea & vomiting q 1hr till 0600.
Weak knees shaky. Racing heart.  No treatment,  stayed at pharmacy for about an hour until it subsided.  Wasn't anxious but thought it was similar in behavior to anxiety .
This spontaneous report as received from a Nurse practitioner refers to an unknown number of patients of unknown ages and genders. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # L048236 expiration date 31-MAR-2018. Dose, route and frequency were not reported. No other suspect or concomitant therapy was reported. The doses were stored at 31.8 F for 1500 hours. The reporter stated that their office was not aware of any adverse effects from these administrations. This is one of two reports received from the same reporter (1606USA011808). Additional information has been requested.
mom reports patient had high pitched scream for 2 days assoc. with vomiting and appetite loss after immunization
arm is a little sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm is a little sore) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     Concurrent medical conditions included No adverse event.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm is a little sore). At the time of the report, PAIN IN EXTREMITY (arm is a little sore) outcome was unknown.            Treatment information were not provided.
Mild activation of previous Bell's Palsy on right side of face.  Droopy right eye, eye watering, tinnitus in right ear, sensitivity in right cheek facial nerve, symptoms continue but very mild.  Bell's Palsy first occurred in 2009.
Received Pfizer dose on 4/3/21 first dose (lot# EN6201). On 4/5/21 patient brought in by ambulance where the patient received an ECG which showed normal sinus rhythm and see ambulance run sheet prior to arrival. Patient who reports getting COVID-19 vaccination 2 days ago presenting with diffuse myalgias, fatigue, headache, perceived difficulty breathing, and tactile fever. She reports feeling these symptoms have also caused her some anxiety, which she has had cause some difficulty breathing before. She denies cough or wheezing. She denies abdominal complaints. She has not taken anything for her symptoms at home.
got the flu shot 2x & both times got sick as a dog 1; Initial information received on 19-Oct-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp (Non-healthcare professional).  This case involves an unknown age female patient who experienced got the flu shot 2x & both times got sick as a dog 1 after receiving Influenza Vaccine.  The patient's past, medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, medical treatment (s), concomitant disease or risk factor.   On an unknown date, the patient received an unknown dose of suspect Influenza Vaccine produced by unknown manufacturer (with an unknown strength, formulation, expiry date and lot number) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).  On an unknown date, the patient got the flu shot 2x & both times got sick as a dog 1 (illness) (unknown latency).  It was reported, i du not du any kind of vaxines &\or shots got the flu shot 2x & both times got sick as a dog 1 of the 2x i was pregnant with my son it caused major problems for me & i so swar off any of the covid vaxines & boosters after what i heard about them.  It is unknown if the patient experienced any additional symptoms/events  It is unknown if there were lab data/results available.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  Outcome: Unknown
J&J Dose 4/10/21 (042A21A) COVID Positive 5/10/21  5/10/21: This is a 71-year-old male with history of left CVA, right minimal hemiplegia, diabetes mellitus, hypertension, right lower extremity DVT, depression and obesity.  The patient is saying he feels excessively weak and fatigued in the last 2 days for which he decided to come to the emergency room.  He denies any shortness of breath, wheezing, cough, chest pain.  He is a former smoker and does not know any history of COPD.  He thinks he is passing urine regularly.  He denies any polyuria, nocturia, difficulty passing urine or any history of BPH.  His diabetes was poorly controlled for few years and patient does not know how much insulin he is taking at this time. He took covid 19 vacine on April 10.  5/15/21: Patient was admitted on the 10th with complaints of weakness, fatigue going on for at least 2 days.  Patient was diagnosed with COVID-19 positivity.  Chest x-ray showed bilateral airspace disease.  Patient also had acute renal failure.  Patient was given supplemental oxygen, started on IV remdesivir, IV dexamethasone, IV ceftriaxone, and IV Zithromax.  The patient's oxygen use was attempted to wean down.  Patient finished course of IV remdesivir, ceftriaxone, and Zithromax in the hospital. Renal function improved.  Losartan was discontinued in the hospital.  Home O2 walk was done today.  Patient to finish oral dexamethasone.  Home Health services were provided. Discharged home today.  Advised to remain in isolation.
Patient is showing symptoms of Bell's palsy; Face numbness, and it is pretty bad; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (Patient is showing symptoms of Bell's palsy) in a  patient of an unknown age and gender 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.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BELL'S PALSY (Patient is showing symptoms of Bell's palsy) (seriousness criterion medically significant) and HYPOAESTHESIA (Face numbness, and it is pretty bad). At the time of the report, BELL'S PALSY (Patient is showing symptoms of Bell's palsy) and HYPOAESTHESIA (Face numbness, and it is pretty bad) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.  Company Comment: This case concerns a patient of unknown age and gender who experienced serious expected event of Bell's palsy on unknown date after receiving both doses of the Moderna Covid-19 vaccine. No medical history provided. Dechallenge is unknown and rechallenge is unknown. The benefit-risk relationship is not affected by this report for the Moderna 19 vaccine.; Sender's Comments: This case concerns a patient of unknown age and gender who experienced serious expected event of Bell's palsy on unknown date after receiving both doses of the Moderna Covid-19 vaccine. No medical history provided. Dechallenge is unknown and rechallenge is unknown. The benefit-risk relationship is not affected by this report for the Moderna 19 vaccine.
54yo patient self reports a reaction to the H1N1 vaccine. Patient reports a local reaction from his H1N1 injection which occurred the day after receiving it. Patient developed an injection site reaction approximately 4 cm circumference with associated tenderness and pruritis. The same day the patient developed diarrhea which resolved in twenty four hours. Respiratory symptoms (cold symptoms) started two days later. Patient recovered. No treatment was required other than rest/time.
Tinnitus. Developed 2-3 weeks after receiving Pfizer booster. I received 2 doses of Moderna vaccine earlier in year with no adverse side effects.  Tinnitus remains unresolved.
I received my 2nd Pfizer COVID 19 vaccine on May 4th.  6 hours after the shot, I had severe pain in my lower back, left side with some queasiness when not lying down.  Tuesday night and Wednesday were the worst. Tylenol helped alleviate the pain quite a bit, but I was only comfortable when laying on my left side. This lasted off and on thru Thursday, May 6th. I missed work Wednesday and returned to work on Thursday; although I still had some discomfort on Thursday.   Then when I awakened Friday morning, it was gone and no pain since then. The pain was not like your typical muscle ache. It was similar in pain to a kidney stone (which I had several years ago and am familiar with that pain).
Mild to moderate left arm pain on first couple of days after vaccine, which was not bothersome, followed by constant, numbness and tingling in left hand, started yesterday, has not gone away, and nothing seems to make it better or worse. Does not affect daily functioning currently, has remained the same/not worsened or spread, but is moderately bothersome and uncomfortable. I have never had any symptoms like this before.
Moderna COVID-19 Vaccine EUA  Covid Arm:  Approx 4" circular painful and  itchy rash around injection site.   See https://www.health.com/condition/infectious-diseases/coronavirus/covid-arm-rash-moderna
Patient developed symptoms consistent with cellulitis on R thigh, treated with Cephalexin.
On April 10, 2023, I started having a light fever of 101F, chills, I was very tired. I took a home COVID-19 test the next day that came back positive. I called, spoke to my doctor's office about my positive test result. We decided that I should take the Paxlovid, I was able to finally get the medication and start it on Thursday. I developed a cough that did lingered for three weeks.
Initial unsolicited report received from a non-healthcare professional  on 7 December 2015. This case involves 18 patients (age and gender not reported) who were vaccinated with a dose of 0.5 ml FLUZONE QUAD ( batch number, expiration date, dose, dose number, route and site of administration were not reported) on an unspecified date. The patient's medical history and concomitant medication were not reported. On an unspecified date, following the vaccination, 18 patients out of the 20 that were vaccinated experienced unspecified adverse reaction. Laboratory investigation and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
I was urinating bright red blood.  This was not dark urine, it was blood that was seeping through my underwear.  No other symptoms to report.