chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse event; received expired doses; This spontaneous case was reported by a patient family member or friend and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received expired doses) and NO ADVERSE EVENT (no adverse event) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025l21b) for COVID-19 prophylaxis.     No Medical History information was reported.   On 23-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (received expired doses). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received expired doses) and NO ADVERSE EVENT (no adverse event) outcome was unknown.     No concomitant medications were reported. No treatment medications were reported.
Sinusitis, thick excessive discharge of clear mucus from nose, 14 days, treated with antihistamine & Tylenol.  After booster had same symptoms lasting about 7-10 days.
This case was reported by a nurse via call center representative and described the occurrence of tendonitis in a 29-year-old female patient who received ENGERIX B adult (batch number BX2X3, expiry date 13th July 2019). On 5th July 2017, the patient received the 2nd dose of ENGERIX B adult .5 ml. On 6th July 2017, 1 days after receiving ENGERIX B adult, the patient experienced tendonitis (serious criteria disability), bursitis (serious criteria disability) and injection site pain (serious criteria disability). On 9th July 2017, the patient experienced shoulder pain (serious criteria disability). On an unknown date, the outcome of the tendonitis and injection site pain were unknown and the outcome of the bursitis and shoulder pain were not recovered/not resolved. The reporter considered the tendonitis, bursitis, injection site pain and shoulder pain to be probably related to ENGERIX B adult. Additional details were provided as follows: The patient received ENGERIX B adult in the right deltoid. On 6th July 2017, the patient (who was also an employee at the reporter's office) complained of normal injection site soreness. On 9th July 2017, 4 days after vaccination, the patient went to emergency room at 2:30 am complaining of severe pain in the right shoulder. The patient returned that same day at 11:00 pm and was diagnosed with tendinitis. The patient was waiting for the results from a magnetic resonance imaging (MRI). The nurse read the clinical reports as stating bursitis and adverse effect of other vaccine and biological substances at initial encounter.
On September 24, 2021 I experienced extreme cramping in my calf that wouldn't go away and my doctor insisted I get an ultrasound. They discovered a DVT in my thigh.
Arm was swollen, red, painful from elbow to shoulder. Patient came to ER, was kept over the night and given antibiotic.
Large rash at injection site   got shot in rear,  Hydroxyzine Pam, Triamcinolone Acetonide Cream USP  Rash cleared up in 5 days
Patient tested (+) for Varicella on 9/21/10. He had received (1) dose of VARIVAX on 8/29/2001. No treatment needed.
pt recvd vax & 2 hrs p/vax exp feet swelling, swollen hands, swollen lips, dyspnea, pruritis, sunburn appearance, paresthesia in forearms, fingertips & feet, numbness in shoulder, lump @ inject site, & diarrhea; pt seen by MD & tx Decadron
three babies died one of them being stillborn and all 3 mother were vaccinated.; This is a spontaneous report from a contactable Other HCP. A female patient (pregnant) received BNT162B2 (COMIRNATY, Lot number unknown) at single dose for COVID-19 immunization on unknown date. Relevant history and concomitant drugs were unknown. The patient experienced stillborn on unknown date. The mother was vaccinated. The outcome of event was unknown.     The lot number for [BNT162B2], was not provided and will be requested during follow up.
Admission Date: 10/12/2022 Discharge Date: 10/16/2022    Admitting Diagnoses: Pneumonia due to COVID-19 virus PRESENTING PROBLEM:  Hypoxia [R09.02] Acute hypoxemic respiratory failure due to COVID-19 (HCC) [U07.1, J96.01] COVID-19 [U07.1]   HOSPITAL COURSE: Patient is a 83 y.o. male who presents today with a history of a dental carcinoma left lung, cardiomyopathy, AFib, chronic obstructive pulmonary disease.  Patient currently is receiving chemo for his lung cancer.  Last chemo treatment was 3 weeks ago.  On Monday patient began to feel increased fatigue so he decided to take a COVID test at home which ended up being positive.  Tuesday patient began to experience nausea and vomiting which did that go away.  He then decided he would go to the emergency department to be evaluated.  Patient denied fevers, chills, chest pain, abdominal pain.  Upon arrival patient was hypoxic.  Patient's baseline is 2 L but was requiring 6 L nasal cannula upon arrival.  CTA thorax was obtained which showed right upper lobe infiltrate which was likely pneumonia.  Due to patient's WBC of 12.42 and lactic acid of 3.2 patient was placed on Rocephin and doxycycline.  Patient did meet severe sepsis criteria based on WBC, lactic acid, no source of infection and respiratory rate.  Other lab work showed BNP 3790, initial troponin of 43, hemoglobin 12.5.  Repeat troponin was 41 for delta -2. CT abdomen pelvis was obtained due to nausea and vomiting.  Imaging showed  no acute inflammatory changes in the abdomen or pelvis.  Moderate left pleural effusion and adjacent left basilar atelectasis.  Hospitalist services was contacted and accepted patient for severe sepsis, acute on chronic respiratory failure and COVID-19.   Patient was admitted and treated with steroids and remdesivir.  He was also given empiric antibiotics and bronchodilators.  His condition improved slowly.  He did have 2 positive blood cultures for Staphylococcus capitis.  He was started on vancomycin empirically and Infectious Disease was consulted.  It was felt this likely represented colonization rather than true infection.  Follow-up blood cultures were negative and vancomycin was discontinued.  He was able to be weaned off oxygen.  He completed a 5 day course of antibiotics while hospitalized as well as a course of remdesivir.  He was discharged home in stable condition with plans for follow-up with his primary care provider.
Narrative: He'll be admitted for generalized weakness and COVID19 vaccine reaction. Symptoms: Symptoms: 1. Myalgia, 2. Patient got his fourth COVID19 vaccination yesterday. Yesterday evening started feeling myalgia, rigors, generalized weakness which continue today. He reported subjective fevers but didn't measure it at home. Weakness
Client c/o headache, dizziness, nausea and slight lethargic.  Client verbalized that she has a chronic HTN that is always extremely high for which she is on multiple antihypertensive med.  Client seen and assessed by EMT and vital signs are: BP 192/114, HR 88, O2 98.  Client advised to call pcp for follow up due to medical history.  Client verbalized understanding.  Client cleared to go by EMT.
Cellulitis at site of injection currently being treated with antibiotics, anti inflammatory diphenhydramine (2 days after injection).
received Pfizer vaccines on 3/30, 4/22/21 tested positive for COVID by PCR on 10/17/21 admitted to Hospital on 11/2/21 for surgery.
Patient calling to report that he received his 3rd dose of Pfizer on 9/28/21. That evening began to have a lot of joint and body aches, headache, very sore arm "unable to lift it". He did not take anything initially, but yesterday/last night he did need ibuprofen to sleep and took it again this morning. In general body aches and headache are better (he is able to work) but he noticed what sound like a reactionary lymph node tenderness in his right axilla this morning. He denies fever, swelling, or redness and states that he cannot palpate any lymph nodes but says there is one spot on under that arm that received the vaccine that is quite tender.
Patient reports he received his 1st Pfizer COVID vaccine on 3/1/21 at about 1:30 pm, and reports within two hours he had extreme fatigue and memory issues "like in a fog".  Patient reports on 3/2/21 and 3/3/21 he continued to feel like he was in a fog, and "today 3/4/21 he almost feels like he ought to be in a senior citizen home, forgot how to get his voicemail(s), and feeling like someone drugged the patient and patient reports he does not drink or take drugs".  Patient reports "he is an intelligent man and normally exercises 7 days a week".  Patient denies fever, pain/redness/swelling at the injection site, and any reaction to vaccines in the past.
temp spike to 104 24 hours after injection and lethargic.  unable to get temp down at home, labored resp at 60, altered loc and cheynne stokes respirations and apnea of 35 seconds. Bright redness, very hot to touch measuring 4cm x 5cm and somewhat endurated at injection site and unable to touch the entire arm due to pain. Admitted to hospital treated with motrin Q3 hours alternating with tylenol Q3hours, solumedrol 30 mg IVP Q24, Rocephin 1 gm IVPB Q 24 for cellulitis at the injection site. Sent home on Keflex 250mg TID for 5 days. Orapred 15mg BID for 2 days.
pt recvd vax;pt screaming @ 1pm,high pitched till 8pm;leg swollen, hot,red,hard;apap given; T 102;pt much better 16mar95;
pt recvd  vax; exp local rxn, rash & swelling down lt arm;
MMRV 2 d ago - now with swelling, redness at site - mild induration - approximate 3" area of redness - possible sterile abscess.
Information has been received from a pharmacist concerning a 60 year old female with no pertinent medical history or drug allergies who on 04-JAN-2008 was vaccinated SC with a 0.65 ml dose of Zostavax (Oka/Merck) (lot# 658839/1411U). There was no concomitant medication. On that same day the patient experienced dizziness. The patient did not seek medical attention. No labs or diagnostic studies were performed. The patient was not recovered at the time of this report. There was no product quality complaint. Follow-up information from a physician indicated that the patient was not administered Zostavax (Oka/Merck) (lot# 658839/1411U) in the office. No further information is available.
This spontaneous report as received from a physician refers to a 78 year old female patient. Concurrent or medical conditions were not reported. In 2008, the patient was vaccinated with ZOSTAVAX (dose, strength, frequency, route and lot were not reported). Secondary suspects and concomitant therapies were not reported. The physician reported that about a year later, in 2009, after receiving ZOSTAVAX, the patient started having a burning pain without rash in the right lateral abdomen. The outcome of burning pain without rash in the right lateral abdomen was not reported. Additional information has been requested.
Information has been received from a consumer concerning her 67 year old husband with no known medical history who in "late" February 2007, was vaccinated with a dose of Zostavax. There was no concomitant medication. Subsequently one week after vaccination in approximately March 2007, the patient experienced a rash with lesions on both of his arms. The patient sought medical attention, but was not diagnosed as having shingles. At the time of the report, the patient had not recovered. Additional information has been requested.
SORE THROAT; This spontaneous report received from a consumer concerned a 72 year old male. The patient's height, and weight were not reported. The patient's past medical history included: covid-19 infections. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 26-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-JAN-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) Positive. On 05-JAN-2022, the patient experienced sore throat. Laboratory data included: COVID-19 rapid POC test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore throat. This report was non-serious. This case, from the same reporter was linked to 20220107982.
I experienced a breakthrough case of COVID-19 with cough, runny nose, body aches and fatigue.
A little sore arm; This is a spontaneous report from a contactable consumer (reporting for his co-worker). This consumer reported for similar events. This is the second of the two reports.   A patient of unspecified age and gender received the first dose of bnt162b2 (also reported as PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date SINGLE DOSE for Covid-19 immunization. The patient medical history and concomitant medications were not reported. The reporter was reporting that she had some side effects from the covid vaccine. She got the first dose on 22Dec2020 fine with just a little sore arm. Then got the second on 26Jan2021 (Tuesday) and on Friday she was in the ER for chronic pain in right side of her body. She says that she was experiencing a sharp pain or sensation of burning. The reporter later checked on the patient (a coworker) and experienced the same. The reporter just wanted to know if there are some reports of that. The outcome of the event was unknown. Case was considered as non-serious.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021105945 same reporter/drug/event, different patient
Patient received injection and immediately had a vagal episode and started to fall over . The father and the vaccinator picked up the patient and laid her on he floor.  Patient alert and orient, pale in color, no loss of consciousness, initial pulse rate 60, Systolic B/P 80. Patient c/o nausea and patent laid on her side but did not vomit.  Cold compresses were  applied to neck , back and forehead. After about 10 minutes patient's color improved, patient denied any nausea or dizziness. Parents stated this has happen before when receiving vaccinations. Patients was discharged via a wheelchair with parents to recovery for and additional 15 minutes. Patient left with parents fully recovered from episode.
LOSS OF TASTE; LOSS OF SMELL; This spontaneous report received from a consumer concerned a 35 year old male. The patient's height, and weight were not reported. The patient's past medical history included: cold. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced loss of taste, and loss of smell. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the loss of taste and loss of smell was not reported. This report was non-serious.
Full body hives, large, red; Full body hives, large, red; very itchy; This is a spontaneous report from a contactable consumer (patient). A 25-year-old female patient not pregnant received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the Right arm on 23Jan2021 at 10:00 AM as a single dose for COVID-19 immunisation, lot number: EL9262. Medical history included allergies to sulfa drugs, Cillin drugs, codeine, salvia officinalis (SAGE). Concomitant medications in two weeks prior to the vaccination included birth control prescription. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. On 23Jan2021 at 06:45 PM patient experienced full body hives, large, red, very itchy. Events resulted in Doctor or other healthcare professional office/clinic visit. Events were treated with Prednisone prescription. At the time of the report, patient had not recovered from the events.
On 1/4/16 at 12:00 PM, patient started complaining of pain at the injection site.  By 4:30 pm parents reported swelling at the injection site and per health department recommendation began applying ice and Tylenol given for discomfort.  On 1/5/16 patient was still complaining of pain when she awoke and by 3:30 pm parents reported she was having difficulty walking.  On 1/6/16 parents reported that patient was unable to bear weight on her left leg and that her leg was very swollen and red.  Patient was seen later that day at the Doctor's office and they noted she had a temp of 100.0 and noticed some red blotches on her left thigh.  Laboratory testing was done and patient was admitted to hospital with cellulitis.
Started a few days after imms - nerve damage (very painful) in balls of feet & hands & mid back. Better now, but still 4-5 pain scale of 1-10 in hands & feet, 1 - feet.
Flare of chronic PNH with complications including hemolysis, AKI and transaminitis.
erythematous demarcated macule at injection site, 4cm x 8 cm, onset 7 days post-injection, consistent with delayed type hypersensitivity reaction
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 58 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ESTROGEN; PROGESTERONE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid. Clinical course: Patient was received Paxlovid for treatment of Covid-19 from 31Aug2022 to 05Sep2022. The patient received other medications which included Hormone replacement therapy (Estrogen patches and progesterone pills) in 2weeks. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Slight ache in muscle of arm where the injections was given starting on the day after the injection. Recovered in two days.
12 years-old patient was administered INFANRIX; administered INFANRIX instead of BOOSTRIX; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 12-year-old female patient who received DTPa (Infanrix) (batch number 49TM3, expiry date 28th May 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd September 2021, the patient received Infanrix (intramuscular) .5 ml and Infanrix Pre-Filled Syringe Device. On 22nd September 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter called from physician's office. The 12 years old patient received dose of Infanrix in right deltoid instead of Boostrix, inappropriate age at vaccine administration and wrong vaccine administered. The reporter gave a consent to follow-up with herself.
This spontaneous report was received from a 54 year old female patient who was a pharmacist and was reporting on herself. The patient did not have concomitant medications, pertinent medical history and any drug reactions or allergies. On 11-APR-2016, the patient was vaccinated with a dose of ZOSTAVAX (dose: 0.65 ml, via subcutaneous route, lot # L040445, expiration date 15-JAN-2017). On 11-APR-2016, the patient experienced burning sensation, redness and a welt at the injection site immediately following the administration of ZOSTAVAX. The patient sought unspecified medical attention. There was no lab diagnostics and studies performed. The patient's outcome was reported as recovering/resolving. The relatedness between the events and the therapy with ZOSTAVAX was not provided. Additional information has been requested.
38C fever and chill lasted  for more than 22 hrs. Serious  headache lasting for 72hrs. Nausea and dizzy showed up at same time with headache. Breath difficult happened on 29th Apr afternoon around 2pm.
EAR  ACHE PAIN, JOINT PAIN,  UPSET STOMACH, HEAD ACHE, CHILLS, SINUS.  NO TREATMENT AND NO OUTCOMES!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!  WHERE DO I GET THE TREATMENT???????????????????????????????????
Patient's wife stated on 3/12 patient became extremely confused, weak and fell 3 times. She stated that they were having difficulty getting him up and her daughter called EMS. Patient was taken to hospital and admitted.  Patient is still in hospital, she stated he is more lucid. Patient has history of  Parkinson's
This spontaneous report as received from a registered nurse refers to an 86 year old female patient with history of having fever blisters and no known drug reactions or allergies. On 17-APR-2013, the patient was vaccinated with a dose of ZOSTAVAX lot # H019999, expiration date 02-FEB-2014, subcutaneously. On 18-APR-2013, the patient experienced flare up of fever blisters on her lips after receiving a dose of ZOSTAVAX. The patient received mineral oil, oxybenzone, BLISTEX as treatment. There were no laboratory diagnostics studies performed. The outcome of flare up of fever blisters on her lips was reported as not recovered/not resolved. The patient sought medical attention by calling the nurse. Additional information has been requested.
Myalgia, Fever, LOSS OF TASTE AND SNELL, CHILLS Narrative: SWABBED FOR COVID 12/28 NEGATIVE RESULT