chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received on 07 February 2008 from a health care professional. A 64-year-old female patient, with a past medical history of diabetes and unspecified neck surgery, had received a left deltoid, intramuscular injection of Fluzone SV 2007-2008, lot number U2486AA, on 16 January 2008. The patient had been administered the last dose from a ten dose vial. (It was the reported that the nine previous patients had experienced no symptoms.) The patient had no illness at the time of vaccination. Two days post-vaccination, the patient developed a fever of 105 degrees Fahrenheit and pain high on the left side of the neck with redness that spread to the shoulder. There was no reaction at the injection site. She was examined in an emergency room and subsequently admitted to the hospital with the admitting diagnosis of "sepsis from inoculation." WBC was 35,000. Unspecified CT scan and chest x-ray were negative. Neck x-ray showed old post-surgical changes with a reactive lymph node on the left side. The patient was treated with five days of "antibiotics" and improved. She was discharged to home. The day following discharge, she was examined by a physician and was continuing to complain of left sided neck pain, generalized weakness, and tenderness and numbness of the sternum. She was treated with Keflex and was scheduled for a bone scan to rule out osteomyelitis. At the time of this report, the patient had not recovered.
1 1/2 to 2wk post vax pt devel cold, rash, sore throat, temp today by MD dx measles;put on ATB;
Vaccine administered after published expiration date.  We received the vaccine from the distributor  02/16/2023, the vaccine had expired 02/12/2023.  With multiple Moderna expiration extensions, the vaccine was labelled with the incorrect expiration date at our facility.  While double checking vaccine expirations, the discrepancy was discovered.  We contacted the distributor and they corroborated that the vaccine was sent after the expiration date had passed.  We contacted Moderna who then performed a vaccine analysis of that lot number.  We contacted the recipient of the Moderna vaccine notified them that the vaccine was administered after the expiration date.  Patient verbalized understanding and stated they would just wait for their follow up vaccine and does not desire to repeat dose.  The patient was advised to talk with their PCP.
feel sick; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "not recovered", described as "feel sick".  Additional Information: It was reported that, she felt fine before she got the shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Moderate tingling to arms, itching throat, and flushing. Vital Signs 1315 - HR 91, RR 24, SPO2 99% Vital Signs 1320 - BP 125/88, HR 86, RR 20, SPO2 100% Vital Signs 1335 - BP 109/80, HR 84, RR 16, SPO2 98% Vital Signs 1345 - BP 123/90, HR 89, RR 16, SPO2 100%
Tiredness, dizziness, redness, swelling (about 2.5-3 inches), warm and pain at the injection site on her left arm.
Developed hives, pruritus, respiratory distress. Received epinephrine SC, Decadron, Zofran and Benadryl IV, Claritin orally.
A report has been received from a Health Professional concerning a 3 year old, male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on 03-Aug-2013. The patient experienced diarrhea and fever 103 degrees which started on 17-Sep-2013. The outcome of the event of diarrhea and fever 103 degrees is unknown. The report was considered to be non-serious.
Patient unable to be reached, VM is full. Will attempt to contact patient again on 10/06/22. Patient incorrectly received Moderna Monovalent COVID-19 vaccine booster rather than the Moderna Bivalent COVID-19 vaccine booster.
49 year old received the 1st dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 49-year-old female patient who received Herpes zoster (Shingrix) (batch number E99E7, expiry date 11th May 2023) for prophylaxis.   On 26th November 2021, the patient received the 1st dose of Shingrix. On 26th November 2021, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.  Additional details were provided as follows: The pharmacist reported that the 49 year old patient received the 1st dose of Shingrix, which led to inappropriate age at vaccine administration. The reporter was not sure if the patient was at an increased risk of HZ due to immunodeficiency or immunosuppression caused by known disease or therapy. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
I26.99 ACUTE PULMONARY EMBOLISM 3/27/2023 ACUTE PULMONARY EMBOLISM
I received my Moderna booster for COVID-19 on 12/21/2021. In about June or July 2022, I noticed that huge clumps of hair would appear on my shower floor whenever I took a shower. Before then, I had always had thick, waist-length hair. However, my hair is now chin-length. It's not because I have cut or trimmed it. It's just because my hair has consistently fallen out every time I shower or comb my hair since June or July 2022. Thankfully, I don't have any bald spots at this point, but I don't know if I will eventually get those, also, since my hair is consistently getting thinner and thinner. My family has given me various products to see if they would help the issue. I have rubbed rosemary oil and "beard oil" into my scalp, but they didn't help. I also tried argan oil, which is expensive, and it also didn't help. At this point, I try to avoid combing or brushing my hair for fear that more will fall out. When I went to the NP for a checkup in September or October 2022, she asked me if I was born with a heart murmur, because she detected a murmur.  I was not born with a heart murmur, so she referred me to a cardiologist. I saw the cardiologist on 12/1/2022, and he told me that my heart valve was not closing completely; I am scheduled to undergo testing on 1/24/2023. On 12/2/2022, I had severe pain in the lower right region of my abdomen. I was buckled over and couldn't even walk. My husband took me to the hospital. At first, they thought that I had appendicitis, but they discovered that the pain was caused by chronic colonic necrosis. Part of my colon was not getting adequate blood supply, so it was dying. However, they did not know what the cause was, so they have arranged for me to undergo a colonoscopy and an endoscopy of the upper and lower GI tract on 2/20/2023. On 12/2/2022, I underwent emergency surgery, in which the cecum and the appendix were removed. I didn't have appendicitis, but they decided to go ahead and perform an appendectomy. In 2021, I had to prepare for knee surgery, and part of my preparation consisted of having my heart, liver, kidneys, and other vital organs thoroughly examined. I also underwent a colonoscopy during this time. No anomalies were detected in the exams, and I was cleared for knee surgery. Until June or July 2022, I had been healthy for pretty much my entire life and was seldom ill. The worst that ever happened had been the occasional sore throat.
A few hours post vax, the pt experienced leg and back weakness with a severe headache and tiredness. Two days later, he experienced high fever and went to ER. On presentation to the ER he was treated with Rocephin and was discharged on the same day, but his condition worsened despite treatment. On 9/7/99, the pt was admitted to the hospital and was dx with serum sickness form vax. He was placed on therapy with prednisone, Tobramycin, and Rocephin. He was discharged on 9/13/99.
PT STATED THAT HE HAD INJECTION SITE RASH FOR 4 DAYS FOLLOWING VACCINE. HE ALSO STATED THAT HE EXPERIENCED SEVERE CHEST PAIN/ACID REFLUX IN HIS CHEST AND BOTH SHOULDERS THE NIGHT THE VACCINE WAS GIVEN THAT AWOKE HIM FROM SLEEP. HE STATED THAT HE THOUGHT HE WAS HAVING A HEART ATTACK SO HE TOOK A 325 MG ASA. HE WENT BACK TO SLEEP AND AWOKE THE NEXT MORNING WITH NO SYMPTOMS. HE STATES THAT HE THOUGHT HE EXPEREINCED SEVERE ACID REFLUX AND WANTED IT REPORTED.
Tachycardia day of administration. Pt was persistently tachycardic and presented to ER day after COVID administration.
This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult male patient of unspecified age. This refers 27 of 84 patients. It was reported that, the patient was administered with AFLURIA (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported) between 25-Oct-2017 to 27-Oct-2017 (as reported). The vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport (explicitly considered as incorrect product storage) instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C) and was administered to the patient (explicitly considered as drug administration error). The reporter stated that, no adverse effects after vaccination were reported. Temperature was not monitored on 24-Oct-17 (could have been between 2-8C, but not certain). Vaccine has since been discarded. Follow-up report received on 09-Nov-2017: It was reported that, the vaccine was administered between 25-Oct-2017 to 27-Oct-2017 (as reported). The reporter stated that, no adverse effects after vaccination were reported. Temperature was not monitored on 24-Oct-17 (could have been between 2-8C, but not certain). Vaccine has since been discharged. Amended narrative accordingly.
Some little bit nausea; shivering; night sweats; fever; flu-like symptoms; Pain at the injection site; Redness at the injection site; Swelling at the injection site; Muscle pain(whole side of body was really in pain); tiredness; bad headache; unable to sleep; Could not raise her arm; Upset stomach; Sore arm of injection; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included tablet does not break into pre-defined pieces, unwell and penicillin allergy.   On 3rd November 2020, the patient received Shingrix. On 3rd November 2020, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site swelling, muscle pain, tiredness, headache, fever, influenza-like symptoms, sleeplessness and mobility decreased. On 4th November 2020, the patient experienced shivering and night sweat. In November 2020, the patient experienced pain in arm and upset stomach. On an unknown date, the patient experienced nausea. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the injection site pain, injection site erythema, injection site swelling, muscle pain, tiredness, headache, shivering, fever, influenza-like symptoms, night sweat, nausea, sleeplessness and upset stomach were unknown and the outcome of the mobility decreased was recovering/resolving.   It was unknown if the reporter considered the pain in arm, injection site pain, injection site erythema, injection site swelling, muscle pain, tiredness, headache, shivering, fever, influenza-like symptoms, night sweat, nausea, sleeplessness, mobility decreased and upset stomach to be related to Shingrix.  Additional details were provided as follows: The patient got her 1st Shingrix shot yesterday (03th November 2020) less than 24 hours ago.  The patient reported sore arm of injection, could not raise her arm yesterday from the day of reporting but it was much better and less sore today.  The patient reported pain, redness (no rash), and swelling at the injection site, muscle pain(whole side of body was really in pain), tiredness, bad headache, shivering, fever, flu-like symptoms, night sweats and some nausea /upset stomach,was unable to sleep last night. The patient did not consent to follow-up.
11:23- Pt father approached RN to check on his daughter. Pt reports blurred vision, feeling dizzy, and feels "everything closing in." RN identifies pallor and diaphoresis and calls for NP and EMT over radio. POD leader and RN assist to lay the patient to the ground with lower extremities elevated on the chair. 11:24-NP and EMT arrive at the scene. NP assesses pt medical h/x, medications, previous meals, current symptoms, menstrual cycle, etc. Pt denies SOB, chest pain, nausea. Pt reports blurry vision and light headedness. Presents with a flat affect. Mental health staff are informed and arrive at scene to speak to father. B/P- 102/62, O2- 94, P- 99. Pt is still on the floor. (Present staff: NP, 2 EMT, POD leader, 3 Observation RNs, safety officer, mental health employees, father. ) 11:30 - diaphoresis and blurry vision is resolved. 11:36- pt is assisted to a sitting position on the floor and denies any abnormal symptoms. BP- 11/3, P- 95, O2- 94%. Pt is warm to touch. Team continues to monitor and pt continues to drink gatorade.  11:41- pt is assisted to chair denies abnormal symptoms. BP- 107/62, P- 98, O2- 98%. NP plans to discharge patient if she continues to feel well.  11:54- NP assesses pt and she reports feeling lightheaded. Pt is assisted to a lying position on the floor with feet elevated on the chair.  BP- 106/64. NP notifies team to contact 911 for further assessment.  11:57- Blood glucose reading 137. 12: 10 EMTS arrive and NP endorsed pt care to EMTs, other EMTs assessing and taking report.  12:15- pt is assisted to a sitting position BP- 113/68, P- 94, patient is advised to seek further assessment in the ED 12:24- patient signs AMA form
Sore throat (2 days), neck ache (4 days so far) small rash on chest (one day), muscle aches (2 days), joint pain (3 days), fever (12 -14 hours), headache ( 2 days), diarrhea (2 days), chills (36+ hours), redness and swelling in injection site and also redness wrapped around arm and some swelling going down my left arm but no redness. This last effect is still present but not as swollen.
p/vax pt devel a rash w/raised lesions;the lesions were generally disseminated across the trunk & upper extremities;dx w/poison ivy & did not have an adverse rxn to vax;
No adverse reaction. Pt was given Hep B 20 mcg/1ml instead of Hep B 10mcg/0.5ml.
doses were given to patient aged 16-17 years; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (doses were given to patient aged 16-17 years) in a 17-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (doses were given to patient aged 16-17 years). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (doses were given to patient aged 16-17 years) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient had no adverse events (AEs).  No treatment information was reported.   This case was linked to MOD-2022-554595, MOD-2022-554702, MOD-2022-554701 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2022: Follow up received contains no new information.
Diverticula; Severe Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Severe Diarrhea) and DIVERTICULUM (Diverticula) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 030m20A) for COVID-19 vaccination.     Concomitant products included TRIAMTERENE and LEVOTHYROXINE for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced DIARRHOEA (Severe Diarrhea). On an unknown date, the patient experienced DIVERTICULUM (Diverticula). On 07-Mar-2021, DIARRHOEA (Severe Diarrhea) had resolved. At the time of the report, DIVERTICULUM (Diverticula) outcome was unknown.            Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Significant Follow-up received on 07-JUL-2021 ADR form attached :  reporter information ,contact details, patient information, concomitant medications, newevent and event outcome were updated.
non-stop screaming from 1-3 hr; high pitched, t101.7 @ PMD ofc; reports vomiting screaming lasted throughout day & noc; seen by MD 430PM; shots given @ approx 830AM;
Mild headache starting on Saturday evening around 7:00pm, January 2nd, took 3 ibuprofen, Sunday morning, January 3rd, woke up around 10-11am body aches, headache, fatigue, swollen lymph node under left arm pit, took 3 ibuprofen around 12:00pm. Headache and body aches subsided slightly but never fully gone.  Around 6:00pm -7:00 low grade fever and chills, took 3 ibuprofen around 8:00pm.  Body aches and fatigue continued to Monday, January 4th, but was reduced in severity, took 3 ibuprofen around 10:00am.  All symptoms with exception of swollen lymph node and heat/swelling/pain at injection site are now gone by Tuesday January 5th.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: pfizer (2 pfizer vaccines) and pfizer (2 pfizer vaccines). Past adverse reactions to the above products included Pain in arm with pfizer and pfizer.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.            No concomitant medications reported by reporter No treatment medications provided by the reporter.
Assessment and Plan Patient is a 78 y.o. male patient with history of prostate CA, depression, CAD, hypertension, hyperlipidemia, migraines, OSA presented with weakness and falls.    Frequent falls Generalized weakness  Ongoing issue for past 6 months to 1 year, subacute worsening with daily falls for the past 1 week Falls certainly multifactorial due to weakness, though history is non specific  Likely acutely worsened by COVID-19 infection and underlying gait/balance disturbance  CT Head (8/17) non acute, but does mention diffusely enlarged ventricles/sulci CT C-spine (8/17) negative for fracture or injury MRI with chronic microvascular changes Echo stable  Less likely seizure activity - some post fall shaking noted, no post ictal state  PT/OT following  Patient was evaluated and was initially recommended He has improved, reevaluated by PT and OT and home with home health recommended. Social worker contacted and arrangements have been made prior to discharge.   Covid-19 Virus Infection Date of onset of symptoms: 2-3 days prior to admission Symptoms present on admission: Cough, rhinorrhea, sore throat, headache, generalized weakness, falls Date of covid positive test: 8/17/2022 Vaccination status: vaccinated Imaging: Chest x-ray nonacute Oxygen requirements on admission: Room air Current O2 requirements: Room air Medical therapy: Started on Remdesivir and Dexamethasone  No longer hypoxic, steroid was stopped on 8/21 Will complete a 5-day course of remdesivir IV prior to discharge today Consultants following: NA Anticipated special isolation end date: 8/25/22   Mild cognitive impairment Some concern for dementia during a recent hospitalization, was seen by neurology and follow-up with improvement Clinical course consistent with MCI/early dementia Due for follow-up with neurology versus center  Hypokalemia Supplement orally.   Leukopenia Thrombocytopenia, POA Likely related to Covid infection  Has had some chronic thrombocytopenia in the past as well Plt 91k on admission, now improved to 130 K Will need opt follow up with PCP    Hx prostate CA Chronic urinary incontinence Following with urology, seen by doctor on 8/16 On active surveillance only, but PSA rising  Plans for outpatient MRI and biopsy Patient to follow-up with urology as outpatient.   Hypertension  BP elevated on admission, pt did not take home medications Resumed home amlodipine and hydrochlorothiazide Resume home regimen at discharge.   Hyperlipidemia Resumed home   OSA CPAP nightly
Night of March 3rd around 8 pm started with an extremely sore arm at injection site.  Had trouble moving arm in an upward motion when bending at the elbow.  Had swelling at the injection site. March 4th (day after the shot).  Still had a lot of arm pain.  After waking up started with a mild headache and cough.  Went to work and started feeling achy and more fatigue.  By 3 pm I had chills and assumed I had a fever.  Went home from work and at 6 pm had a fever that reached 101.  Around 8:30 pm lost feeling on the left side of my face.  I could move my lips but I lost feeling in the left side of my face.   March 5th (2 days after vaccine)-Most symptoms subsided.  Left side of my face still slightly numb by my mouth but mostly resolved.  Fever was gone but still experienced fatigue.  Arm was slightly sore but a huge improvement from the day before.  Cough subsided as well. March 6th (3 days after vaccine)-Slightly sore arm and lingering fatigue.  Felt better than Friday, March 5th. March 6th-8th-Slightly sore arm but all other symptoms went away.
Bilateral conjunctivitis, sore throat, non productive cough. chest tightness, slight wheezes, swelling around eyes and body aches. BENADRYL 25mg times one per day, Ibuprofen 200mg times twice per day, no effect.
who received the first dose of the Pfizer vaccine on 3Mar2021 and since tested positive for covid; This is a spontaneous report received from a contactable pharmacist. A 17-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an un-specified route of administration on 03Mar2021 (Batch/Lot number was not re-ported) at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient underwent lab tests and procedures which includes COVID test and resulted a week later as positive for COVID. On unspecified date patient tested negative to COVID. Therapeutic measures were taken as a result of who received the first dose of the Pfizer vaccine on 3Mar2021 and since tested positive for COVID. It was reported that patient had not received any antivirals therapies. States the patient has been riding it out with Tylenol. Reporter declines to complete a safety report at this time. The outcome of the event was recovered.  Information on the lot/batch number has been requested.