chrisvoncsefalvay/vaers-outcomes huggingface dataset:
we had a nurse combine two doses of 0.25ml that was already in a syringe.into one syringe for a 0.5 ml dose/combining booster dose syringe to administer to patient for regular dose; This spontaneous case was reported by a nurse and describes the occurrence of WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (we had a nurse combine two doses of 0.25ml that was already in a syringe.into one syringe for a 0.5 ml dose/combining booster dose syringe to administer to patient for regular dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (we had a nurse combine two doses of 0.25ml that was already in a syringe.into one syringe for a 0.5 ml dose/combining booster dose syringe to administer to patient for regular dose). At the time of the report, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (we had a nurse combine two doses of 0.25ml that was already in a syringe.into one syringe for a 0.5 ml dose/combining booster dose syringe to administer to patient for regular dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Nurse states that she is old-fashion and prefers to go by the guideline that has been set. Generally they draw up Moderna COVID-19 vaccine at the clinic in the morning for primary dose in a syringe as well as booster dose in a syringe. However, they have other Nurses working at the clinic that are combining booster dose syringe to administer to patient for regular dose. Nurse would like to know if there is a specific documentation that states not to do that in a such event like this.  No concomitant were reported.  No treatment were reported.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jan-2022: Follow-up received and included reporter information updated.
itchy at injection site; Vaccination site induration; redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (itchy at injection site), VACCINATION SITE INDURATION (Vaccination site induration) and INJECTION SITE ERYTHEMA (redness at injection site) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PRAVASTATIN for an unknown indication.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced INJECTION SITE PRURITUS (itchy at injection site), VACCINATION SITE INDURATION (Vaccination site induration) and INJECTION SITE ERYTHEMA (redness at injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, INJECTION SITE PRURITUS (itchy at injection site), VACCINATION SITE INDURATION (Vaccination site induration) and INJECTION SITE ERYTHEMA (redness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
big bump on her arm that was hot and swollen/lump on my arm which was very hot and sore; big bump on her arm that was hot and swollen/lump on my arm which was very hot and sore; big bump on her arm that was hot and swollen/lump on my arm which was very hot and sore; big bump on her arm that was hot and swollen/lump on my arm which was very hot and sore; Big bump on her arm that was hot and swollen; Lump on my arm which was very hot and sore; Bump on my arm; This is a spontaneous report from a contactable consumer(patient). A 49-year-old female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ER2613), via an unspecified route on 17Apr2021 (at the age of 49-year-old) into Arm right as a single dose for COVID-19 immunisation. The patient had previously received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ET6955), via an unspecified route on 27Mar2021(at the age of 49-year-old) into Arm right as a single dose for COVID-19 immunisation. Medical history included stress from an unknown date and unknown if ongoing (stress a lot). The patient's concomitant medications were not reported. She received her second dose of the vaccine on 17Apr2021 and had no side effects other than a bump on her arm that was hot, red, and really sore on an unspecified date in 2021. She received both doses, the only thing she had received as an adverse event was a big bump on her arm that was hot and swollen; just like a lump on her arm which was very hot and sore for a few days but that was all that happened. The patient underwent lab tests and procedures which included antibody test: negative on a negative antibody test after being fully vaccinated on an unspecified date in 2021. The outcome of the events was unknown.
Arm was sore for a day; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore for a day) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 039B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore for a day). At the time of the report, PAIN IN EXTREMITY (Arm was sore for a day) outcome was unknown.            No concomitant medication was reported.  No treatment information was reported.       Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Follow-up received contained updated patient's address
Leg tender, temp 104, constant whimper, can comfort while holding, APAP does not reduce fever;
Initial information received on 12-Oct-2018 regarding an unsolicited valid non-serious case received from a physician (patient herself). This case involves a female patient (age not reported) who experienced swelling at the site about 10-15 cm in size with redness, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history and concomitant medications were not provided. On 11-Oct-2018, the patient received a single 0.5 ml dose of suspect Influenza Quadrival A-B Vaccine, lot UJ035AA via intramuscular route in the left deltoid. On an unknown date, the patient developed a non-serious swelling at the site about 10-15 cm in size with redness following the administration of Influenza Quadrival A-B Vaccine. (Other relevant tests included no lab tests.) Final diagnosis was swelling at the site about 10-15 cm in size with redness. It was unknown if corrective treatment was received by the patient or not. The patient outcome is reported as Unknown for swelling at the site about 10-15 cm in size with redness. List of documents held by sender-None.
burns like an allergic reaction; itches; slight redness; This spontaneous case was reported by a patient and describes the occurrence of INJECTION SITE PRURITUS (itches), INJECTION SITE ERYTHEMA (slight redness) and INJECTION SITE PAIN (burns like an allergic reaction) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced INJECTION SITE PRURITUS (itches) and INJECTION SITE ERYTHEMA (slight redness). On 16-Feb-2021, the patient experienced INJECTION SITE PAIN (burns like an allergic reaction). At the time of the report, INJECTION SITE PRURITUS (itches), INJECTION SITE ERYTHEMA (slight redness) and INJECTION SITE PAIN (burns like an allergic reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's concomitant medications included unspecified cholesterol medications.   No treatment information was provided.
Case completed primary Covid vaccine series in May 2021, then was hospitalized for Covid in May 2022. COVID-19 virus infection. Assessment & Plan. Reports recent symptomatic COVID-19 infection with positive home test 5/7. Per her daughter, she had symptoms 5/4-5/8 with cough and not feeling well. Her daughter notes that she complained of cough and shortness of breath 5/15 and she was concerned about pneumonia due to prior history. She is not hypoxic and does not qualify for any COVID treatment (dexamethasone). CXR is negative. Dyspnea; Assessment & Plan. Her dyspnea is likely multifocal with contributors consisting of deconditioning, heart failure, sleep apnea and a recent COVID infection in early May. She does not appear fluid overloaded but her body habitus makes it difficult to assess. She does report improvement in her breathing this morning. Also considered other causes of shortness of breath like pulmonary embolism but with chronic use of warfarin that is less likely.
nausea, diarrhea, weakness, low back pain, headache with fever that started around 5:30pm yesterday 4/19/21 after her first pfizer vaccine on 4/19/21.  Taking ibuprofen and APAP. Reports contracting covid in December and feels similar.  advised her to take electrolyte replacement, continue ibup & APAP.  BRAT diet.  Advised to contact her primary doctor if symptoms worsen. Informed her we will contact her tomorrow to monitor her symptoms.   4/23- Three f/u calls unable to reach.
Muscle pain, increasing dramatically to the point of severe pain, unable to walk or move without extreme pain in back, legs, arms
Approximately two weeks after second dose Pfizer vaccine chronic hives. Assumed it was a reaction to other environmental or dietary cause. Began to look for cause by elimination/addition (food diary, etc.) After booster of moderna December 17, hive outbreak was so intense I needed four diphenhydramine 25 mg capsules to ease symptoms. Currently taking 3 diphenhydramine 25 mg every evening, 2 cetirizine every morning. When I discontinue either antihistamine, I have an outbreak. This has been continuous problem for about 8 months.
chronic upper respiratory illnesses every two weeks, seen by allergy, pulmonary, ENT, CT Chest noted bibasilar atelectasis, treated with multiple medications and still not fully well
09/15/08 Hep B vaccine #1 given in R del by LPN. 10/16/08 Hep B vaccine #2 given in R del by RN. 10/23/08 Pt called to report that after the first vaccine was given 5 days later,  she experienced severe vomiting and nausea and missed 2 days work because of it.  Stated she had the same symptoms again today but not "quite as severe as the first." I checked with the Dr. on call and he told me to check with the pharmacy as to what direction to take re: completion of the series. Pharmacist said to complete the series (#3) in 5 months.
No adverse event; received a monovalent Moderna COVID19 vaccine as a booster; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (received a monovalent Moderna COVID19 vaccine as a booster) and NO ADVERSE EVENT (No adverse event) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 083b22a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Nov-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2022, the patient experienced WRONG PRODUCT ADMINISTERED (received a monovalent Moderna COVID19 vaccine as a booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (received a monovalent Moderna COVID19 vaccine as a booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (received a monovalent Moderna COVID19 vaccine as a booster).    No concomitant information was reported. No treatment information was provided.
Patient with a history of well-controlled asthma/COPD presented with asthma exacerbation 24 hours after 2nd dose of Moderna COVID vaccine,(lot 038B21A) on 4/11. Patient also had similar symptoms following the 1st COVID vaccine dose. On 4/13 ED visit, patient was on 3L nasal canula with 98% O2sat. Patient was initially treated with prednisone, continuous albuterol neb, ipartropium, pepcid, and solumedrol, which continued during 3 days of admission. Respiratory symptoms improved. Patient was discharged home on tapered prednisone, tiotropium and albuterol inhalers.
Client describes having right arm pain, swelling, redness, and warmth beginning 7/29/2015. She states she became nauseous, dizzy, and jittery feeling. States she also noted swollen lymph nodes in her groin. Also describes generalized joint pain, worst in her hips and lower back. Client states this lasted throughout the day, almost 24 hours. Client denies fever during this time. She took OTC Aleve once on 7/29/2015. Today, client states all symptoms have resolved, except for her arm still has some swelling and discomfort.
Information has been received from a nurse referring to a 12 month old patient (gender unknown). Information regarding concurrent conditions and medical history was not provided. On an unknown date the patient was inadvertently administered (Merck) VARIVAX and (Merck) PROQUAD concomitantly (dose, dose #, lot #, application site and route were not reported) (overdose). No adverse effect reported. Additional information has been requested.
boosted adult traveler acquired COVID-19 after returning to the; boosted adult traveler acquired COVID-19 after returning to the; This is a literature report for the following literature source(s):  An adult patient received BNT162b2 (BNT162B2), on 10May2021 as dose 2, single (Batch/Lot number: unknown), on 02Jun2021 as dose 2, single (Batch/Lot number: unknown) and on 09Feb2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "boosted adult traveler acquired COVID-19 after returning". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical courses: Boosted adult traveler acquired COVID-19 after returning and was treated with NM/r 300/100 mg taken orally twice daily for 5 days. Case resolved quickly.; Sender's Comments: Based on the compatible time association, the lack of efficacy cannot be excluded for suspect vaccine BNT162B2 administration.
This case was reported by a healthcare professional and described the occurrence of frozen shoulder in a 59-year-old female subject who was vaccinated with Flulaval (GlaxoSmithKline) for prophylaxis.  The subject's medical history included diabetes and hypothyroidism.  The subject's concurrent conditions and concurrent medications were not reported.  The subject had received influenza virus vaccine in previous years with no subsequent adverse events.  The subject received no other immunizations on the date of receipt of Flulaval.  On 26 October 2007 the subject received unspecified dose of Flulaval (unknown, left arm).  On 27 October 2007, 1 day after vaccination with Flulaval, the subject experienced frozen shoulder, injection site pain and injection site soreness.  The subject was seen by an orthopedic doctor.  The subject was treated with Cortizone shot and physical therapy.  At the time of reporting the events were unresolved.  The healthcare professional considered the events were probably related to vaccination with Flulaval.
The patient refers that after 5 minutes post-vaccination, while in observation he had an episode of "feeling dizziness, shortness of breath, heat and sweating, all over his body".  At evaluation by paramedics, they found that the patient had high blood pressure (189/88 mm/Hg- according to the patient). The patient was given oxygen, monitored, and stabilized, after one hour patient was stable and was discharged.  In the afternoon, the patient reported that he continued with dizziness and went by himself to the ER where he was found with high blood pressure and was referred to a cardiologist.  The patient also referred that he developed two days after immunization hair loss, arrhythmia, dizziness, numbness in both upper and lower limbs, smell and taste of metal, daily hot flashes, chest pain, and insomnia. Afterwards, in October 2021, the patient was hospitalized for 2 weeks due to pneumonia, and on 12/8/2022 patient had a heart attack and was hospitalized for 5 days and had a catheterism. The patient is been followed by a cardiologist.
Patient was administered first dose Moderna Covid-19 Vaccine on 5/5/21 at vaccine site.  Returning for second dose on 7/9/21.  This goes beyond the recommended time period between vaccinations and so it is being considered an adverse event.
Long tremors on different parts of the body, first the tremors started in the lower extremities, then it started to move to the torso, and then to the upper extremities, arms and head, and eyes. I experience long periods of brain fog, no walking properly, and numbness in the lower and sometimes up extremities. I have gone to the neurologists multiple times and have done CT scans, MRIs, and other tests. They acknowledge my symptoms but do not know what it is. The first time I went to the doctors, they thought I suffered a stroke.  So they requested I go to the emergency room.
Given Hep A vaccine that expired 11/10. Given on 01/29/11.
In the late 1980s I contracted Dengue Fever in Indonesia.  Dengue symptoms returned for the first time approximately eight hours after receiving the booster shot.  For about 48 hours after the onset, it felt like someone was hammering a chisel into my thigh bones every 10 to 15 minutes, particularly my right thigh.  Heavy sweating and fatigue occurred during the same time frame.  For over two months after the shot I have had chronic fatigue.
Patient was fine leaving the pharmacy. After 1 to 3 hours after receiving ZOSTAVAX vaccine, patient described skin on arm to be itchy, with developing rash on face, arm and stomach, plus having headaches, and muscular pains in back. Patient visited doctor on 3/16/17 and received RX for prednisone. Followed up with patient on 3/21/17, and rash is slowly fading.
This spontaneous case, initially received on 28-Oct-2016, was reported by a health professional and concerns a patient of unknown age and gender. Weight: not provided; Height: not provided. Concomitant medication: not reported. Administration of company suspect drug(s): ON an unknown date, the patient received AFLURIA. Dose regimen: Not reported, Route of administration: Not reported. Batch number: Not reported. No additional suspect drugs. Adverse event description: On an unknown date, someone inadvertently gave a dose of expired AFLURIA from last season (outcome: not reported, special circumstances: expired drug administered without adverse event).
Information has been received from a physician concerning a 25 year old female who, on an unspecified date, was vaccinated with a dose of Gardasil. Subsequently, the patient stood up, felt dizzy and then she fainted and was fine after a couple minutes. The patient sought unspecified medical attention. The patient recovered on an unspecified date. No product quality complaint was involved. Additional information has been requested.
Fever & NauseaVomiting Narrative:  covid test ordered from non-VA provider
ongoing hives from neck to tows; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (ongoing hives from neck to tows) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031a21a) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, the patient experienced URTICARIA (ongoing hives from neck to tows). At the time of the report, URTICARIA (ongoing hives from neck to tows) had not resolved.            For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown), the reporter did not provide any causality assessments. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown) was not applicable. No concomitant and treatment medications were reported.   This case was linked to MOD-2021-137917 (Patient Link).
Injection site redness & swelling, pain with headache started 1 day after the vaccination.
Fever 5+ days Joint pain and stiffness - patient could not bend wrists, ankles or walk without assistance Could not straighten knees Rash started in legs and covered entire body including palms of hands, soles of feet
My son developed a high fever for several days after the vaccination.  He also displayed rapid and uncontrollable shaking,seizure like episodes that resulted in him being hospitalized.  He also experienced breathing difficulty, drowsiness and excessive crankyness/crying.  1/11/08 Reviewed pcp medical records which included vax records w/lot #s & databse updated w/same.  Records reveal patient w/thick eye discharge 10/22/07 otherwise in good health & meeting developmental milestones.  Dx w/conjunctivitis & tx w/eye drops.  Returned to pcp 10/31 w/vomiting,lethargy,  fever, dyspnea, reduced oral intake, & not acting himself x 3 days.  Dx w/viral disease.  Admitted to hospital 10/31-11/1/2007 w/fever & URI.   Returned to pcp 11/26/07 w/purulent discharge from eyes x 3 days, nasal discharge x 4 days, cough. Dx w/conjunctivitis & OM right ear.  Tx w/antibiotics 1/15/08 Reviewed hospital medical records which reveal patient experienced fever & abnormal movements.  Developed low grade fever (99-100) & cold s/s 5 days prior to admit.  Parent & 3 siblings w/colds s/s.  On day of admit, had vomiting & temp max 102.  Parent noted slow rhythmic body contractions followed by drowsiness.  Sent to daycare & continued to have jerky movements & wide based gait noted when taken to pcp on day of admit.  Admitted 10/31-11/1/2007.  On exam had fluid collection right ear. FINAL DX: Viral syndrome.
Information has been received from a physician concerning an 3 year old male patient who on 22-MAY-2009 was vaccinated with first dose of MMR II (dose, route and lot number not reported). The physician reported that the patient developed mumps on 08-DEC-2009. The patient was diagnosed with mumps on 10-DEC-2009. Blood laboratory test performed on 10-DEC-2010: results not reported. Other symptoms presented by the patient included: right parotitis, cough and was not reported. This is one of several reports from the same source. No further information is available.
pt recv vax 2JAN96 & devel weakness in face, drooping eyelids, poss myasthenia gravis;no further details were known as of the date of this report