chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm had yellow-green spot and half at the injection site; aching at C4 and L5/stabbing pain; aching at C4 and L5/stabbing pain and her shoulders were also hurting; shoulders were also hurting; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE DISCOLOURATION (arm had yellow-green spot and half at the injection site), BACK PAIN (aching at C4 and L5/stabbing pain), NECK PAIN (aching at C4 and L5/stabbing pain and her shoulders were also hurting) and ARTHRALGIA (shoulders were also hurting) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048-A21A) for COVID-19 vaccination.     The patient's past medical history included Arthritis, Postmenopausal symptoms, Hysterectomy and Fusion of vertebra (fusion of C4 and L5). Concurrent medical conditions included Acid reflux (esophageal), Blood pressure fluctuation and Thyroid disorder NOS. Concomitant products included PANTOPRAZOLE for Acid reflux (esophageal), LISINOPRIL and CARVEDILOL for Blood pressure management, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder NOS, PARACETAMOL (TYLENOL), GUAIFENESIN (MUCINEX), FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced VACCINATION SITE DISCOLOURATION (arm had yellow-green spot and half at the injection site), BACK PAIN (aching at C4 and L5/stabbing pain), NECK PAIN (aching at C4 and L5/stabbing pain and her shoulders were also hurting) and ARTHRALGIA (shoulders were also hurting). On 15-Mar-2021, BACK PAIN (aching at C4 and L5/stabbing pain), NECK PAIN (aching at C4 and L5/stabbing pain and her shoulders were also hurting) and ARTHRALGIA (shoulders were also hurting) had resolved. On 23-Mar-2021, VACCINATION SITE DISCOLOURATION (arm had yellow-green spot and half at the injection site) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment information was not reported.   This case was linked to MOD-2021-101745 (Patient Link).
Rash in 2 hours waist down; 101 fever in 6 hours. Seen in ER at 11 PM, fever 102-103. Rash head to toe; raised, red. MD felt as if from immunization. Seen MD next day. Rash arms and face and legs. Developed pneumonia.
Pt reportedly developed AMS (extreme sleepiness) and ataxia. Presented to local ER and was admitted for observation, hospitalist felt that he had acute cerebellar ataxia related to vaccination.
20NOV93 rash noted; 21NOV93 seen @ ER for sever itching urticaria rash extremities, trunk, neck; DPh;
Mom called 8/25/04. Said grandmother had brought child with her permission to get shots and "his left arm was twice the size of other arm."
Wake up and had alot of bumps on my right arm, back, and face. I went to the ER and I had a all reaction to something in the flu shot that I had got on 10/07/2009 and the doctor at the hospital prescripted Benadryl for me to start taking.
pt recvd vax & exp severe pain @ the inject site; In f/u MD reported that the exp was not out of the nl reacts;
covid vaccine breakthrough case  dose 1 Moderna 3/8/21  012A21A dose 2 Moderna 4/8/21  017B21A
not received 2nd dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: not received 2nd dose yet).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 18-Sep-2023 A pharmacist asked for information about a patient who received the first dose of Shingrix back in 2020. The pharmacist enquired did the series needed to be re started. The reporter did not provide information about first Shingrix. Due to the nature of the call permission to follow up was not requested. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Anthrax Lot #FAV110 administered after expired date due to administrative oversight.  No adverse reaction at this time.  Report submitted per Milvax direction.
Moderna COVID-19 Vaccine EUA Woke up at 1:30 AM to get drink of water, feeling somewhat lightheaded. Vomited and a few minutes later experienced diarrhea. Went back to sleep, woke up at 7:00 AM. Diarrhea again. Experienced slight headache and some lethargy. Can eat and drink but decided to fast for the day and just drink water. Went to work as usual.  I believe I am recovered now.
Fever of 101 degrees Fahrenheit, lasted about 36 hours. One week later a rash appeared on trunk and spread to back of neck and behind the ears.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Mar2021 as dose 1, single (Lot number: EN6207), in right arm, on 06Apr2021 as dose 2, single (Lot number: EP7533), in right arm and on 17Dec2021 as dose 3 (booster), single (Lot number: FE3594) at the age of 61 years, in right arm for covid-19 immunisation; cilgavimab, tixagevimab (EVUSHELD), on 05Sep2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Other medical history: cancer" (unspecified if ongoing); "Known allergies: yes" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Patient received vaccine. The patient did not receive any other medications in 2 weeks. Patient received treatment with Paxlovid. Treatment start date: 13Nov2022.
In april my right leg began dropping out from under me frequently. Had back surgery on may 12, 21 with minimal relief. Havd been in physical therapy times 1-year with only fair tesults. Now walk with walker.
Swollen lymph node, rear left side of neck. Sore grape size raised lump on lymph node. Lasted 7 days before subsiding
Patient reported full body hives beginning about 8 hours post-vaccination. The hives respond to oral Benadryl 50 mg but return in 4 hours. Patient is still reporting hives 2 days following vaccination, following up w/ PCP for further treatment.
Approximately 30 minutes after the immunization, the patient developed a rash and reported shortness of breath. The patient was prescribed a corticosteroid and was given nebulized ipratropium/albuterol. Patient was returning to normal after about 45 minutes.
Arm hot to the touch, painful. Localized bruising. Tingle, sore.
Information has been received on 21-FEB-2019 from a lawyer regarding a case in litigation, involving a male patient, age and medical history not reported. In and around 16-AUG-2017 the patient was inoculated with ZOSTAVAX for routine health maintenance and for its intended purpose, the prevention of shingles (herpes zoster). A few days after receiving the vaccine, the patient suffered a burning and stinging rash on his face spreading towards his left eye. The patient was diagnosed with herpes zoster on 30-AUG-2017. As a direct and proximate result of the ZOSTAVAX, the patients symptoms have resulted in physical limitations not present prior to the using the product. The patient also experiences mental and emotional distress due to physical limitations and the seriousness of his condition. The patient suffered serious, progressive, permanent and incurable injuries as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment, and injury. The patient required and will continue to require healthcare and services, medical and related expenses, and will continue to suffer mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, diminished quality of life and other losses and damages. Herpes zoster was considered to be a disabling event. Additional information has been requested.
Indurated erythematous patch over right deltoid 8 to 10 cm non tender.
ZOSTAVAX administered on Friday 10/11/2013. The following day pt reported a low grade fever, redness and swelling and pain at the injection site. Pt came into pharmacy on Tuesday 10/15/13 still with severe redness, pain and swelling at injection site. Referred to dr diagnosis -> allergic reaction to vaccine. Pt to continue naproxen and add diphenhydramine checked in with pt today much better but not completely recovered.
This spontaneous report was received from a pharmacist and refers to a 61 year old female patient. The patient's concurrent condition was hypertension and allergy to penicillin. The patient's medical history included breast cancer (the patient was currently in remission). The patient had no concomitant medications. On 19-JUL-2017, the patient was vaccinated with ZOSTAVAX lot # N012492, expiration date 17-MAR-2018 for prophylaxis. Other suspect therapies included sterile diluent lot # N015632, expiration date 18-FEB-2019. On 29-JUL-2017, the patient experienced boil on her chin and fatigue. The patient sought medical attention by visiting a physician, yet no lab diagnostic studies were performed. The outcome of the event was reported as not recovered. The relatedness between the event and suspect therapies was not reported. No product quality complaint was involved. Additional information has been requested.
Pt had abdominal pain, headache, loss of appetite. Awful pain where shot was given.
Patient passed out in the store after flu shot. She woke back up in a couple of seconds. Mother was with her and didn't think we needed to call anyone, she had same reaction to an allergy shot once. Patient was feeling much better in 15-20 minutes. There was no redness or swelling in area of vaccination.
No additional AE reported; the PNEUMOVAX 23 was administered to the patient after the excursion occurred; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapies were not reported.  On 15-MAR-2022, the patient was vaccinated with improper stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot #U022819, expiration date: 14-JAN-2023 (dose, and route of administration were not provided), administered for prophylaxis (Product storage error).   The administered dose of the vaccine experienced a temperature excursion in 1.7 degrees Celsius for 24 hours. There was previous temperature excursion. No additional adverse event (AE) reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2206USA006587: US-009507513-2206USA006432: US-009507513-2206USA006670: US-009507513-2206USA006674: US-009507513-2206USA006731: US-009507513-2206USA006852: US-009507513-2206USA006952: US-009507513-2206USA006981: US-009507513-2206USA007045: US-009507513-2206USA007059: US-009507513-2206USA007068: US-009507513-2206USA007070: US-009507513-2206USA007090: US-009507513-2206USA007094: US-009507513-2206USA007098:
Big red spot on arm, itchy. Gets worse with exposure to heat (hot yoga, hiking in 80° weather). Periodically shows up and then goes away. Started night of vaccination, has continued for about a week. Treating with ice to stop the itching. Fatigue and headache for three days following vaccination.
Went down for a nap at 4 PM. Woke up with soaked shirt from sweat. Fever of 104. Fever continued for over 24 hours, never going below 102 degrees F.
Soreness; Stiffness; Headache; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st September 2020, the patient received the 2nd dose of Shingrix. On 22nd September 2020, 1 days after receiving Shingrix and an unknown time after starting ibuprofen, the patient experienced pain, stiffness and headache. The patient was treated with ibuprofen and paracetamol (Tylenol). On an unknown date, the outcome of the pain, stiffness and headache were unknown.   It was unknown if the reporter considered the pain, stiffness and headache to be related to Shingrix.  Additional details were as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  After receiving 2nd dose of Shingrix, the experienced pain, stiffness and headache. The patient was asking is it safe to take aspirin if necessary. The reporter did not consent to follow up.
presents with worsening dyspnea and hypoxia.  He has been triple vaccinated for COVID-19, and was on a vacation. On 09/05/2021 he started developing symptoms of rhinorrhea and he and his wife both tested positive for COVID-19, same-day.  He has had overall increasing dyspnea over the past 9 days and was able to measure his oxygen saturation which had been fluctuating between 88 and 93%
Present with mother. Has a large red spot where he got his vaccinations yesterday. He removed the band aid last night and there was just a tiny spot where the needle had gone in. This morning the redness had spread, now it is larger. He hasn't acted sick, no fever, is eating and playing as usual. He hasn't been touching it. When questioned he says it hurts. Treatment diphenhydrAMINE 12.5 mg/5 ml oral liquid, 8.75 mg, 3.5 mL, ORAL, TID, PRN. Children's Vitamins with Iron oral tablet, chewable, 1 Tab, CHEW, DAILY, 5 refills. Hydrocortisone topical 2.5% ointment, 1 Applic, TOP, BID.
Initial information received on 22-Mar-2019 regarding an unsolicited valid non-serious case received from Other health care professional (Medical assistant). This case involves a 15 months old female patient who received vaccine DAPTACEL. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ACTHIB and PREVNAR 13 on 21-Mar-2019. On 21-Mar-2019, the patient received a fourth dose 0.5 ml of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5169AA, expiry date 16-Mar-2019 via intramuscular route in the right thigh. It was an actual medication error due to expired vaccine used. It was reported that Expired DAPTACEL vaccine (expiry date 16-Mar-2019) was given to child on 21-Mar-2019. The patient did not experience any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender - none.
SORE ARM; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number is not reported. The company is unable to perform follow up to request batch/Lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore arm was not reported. This report was non-serious.
Anaphylactic type of reaction; A spontaneous report was received from a female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced an anaphylactic type of reaction.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, after receiving the Moderna vaccine, patient reported that she had some adverse side effects and believed she needed an Epi-pen before getting a second dose due to the anaphylactic type of reaction she had. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event, anaphylactic type of reaction, was not reported.; Reporter's Comments: This case concerns a female patient of unreported age.  The patient's medical history is not provided. The patient experienced an unexpected event of anaphylactic type of reaction.  The event occurred on an unknown date and unknown duration after receiving the first dose of mRNA-1273. Very limited information regarding this event has been provided at this time.  Based on temporal association between the use of the product and the event, a causal relationship cannot be excluded. Additional information about the event details are required for further assessment.
body aches; Covid arm; stomach ache; redness on arm; fever; pain in injection site; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), VACCINATION SITE REACTION (Covid arm), ABDOMINAL PAIN UPPER (stomach ache), VACCINATION SITE ERYTHEMA (redness on arm) and PYREXIA (fever) in a 34-year-old female patient 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 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (body aches), VACCINATION SITE REACTION (Covid arm), ABDOMINAL PAIN UPPER (stomach ache), VACCINATION SITE ERYTHEMA (redness on arm), PYREXIA (fever), VACCINATION SITE PAIN (pain in injection site) and HEADACHE (headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, PAIN (body aches), VACCINATION SITE REACTION (Covid arm), ABDOMINAL PAIN UPPER (stomach ache), VACCINATION SITE ERYTHEMA (redness on arm), PYREXIA (fever), VACCINATION SITE PAIN (pain in injection site) and HEADACHE (headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided
This spontaneous prospective pregnancy report was received from a licensed vocational nurse (the call was originally placed by her husband) refers to a female patient of unknown age with no pertinent medical history and drug reactions or allergies. On 10-SEP-2013 the patient was vaccinated with 0.5 milliliters (ml) VARIVAX (Merck) (lot#, expiration date not reported), subcutaneously. Concomitant therapies included prenatal vitamins. The nurse reported that she became pregnant "within two weeks" (approximately on an unknown date in September 2013) of receiving VARIVAX (Merck). She stated that she found out she was pregnant by a home pregnancy test on 28-SEP-2013. She reported that she was seen by her physician on 01-OCT-2013 and a viral load was drawn as well as a titer on that day. She also reported that on 04-OCT-2013 she had a "full panel of lab tests drawn including a CBC." Patient sought medical attention for the event. Additional information has been requested.
(L) leg with redness and swelling from hip to knee and inconsolable crying for over one hour.
Patient complained of body aches & concentrated pain at left leg injection site @ 2:22am.  Patient spiked fever of 102.7 with erythema and swelling of left thigh @ 12:45 am.  Diphenhydramine was administered 2/16/13.  Patient was stable for dismissal that day with instructions to return to our ED if leg symptoms worsen.  She presented to our ED later that day & was admitted to our hospital with diagnosis of left leg cellulitis secondary to pneumococcal vaccine.  She was treated with 1 dose of cefazolin in ED, followed with clindamycin IV on the general floor.  She was dismissed 2/17/13 with instructions & prescription for oral clindamycin x 6 days.
Pt with diarrhea initally, progressed to systemic rash that continues and has had some shortness of breatht that is not otherwise explained.
Patient administered Pneumococcal vaccine in upper right arm.  Area of warmth and redness observed.
Hospitalized;  COVID-19 positive (9.6.21);  fully vaccinated  Admission Date: 9/6/2021 Discharge Date:  09/11/2021  Discharge disposition: Home;  Condition at discharge: Improved Admission Diagnosis: Elevated troponin Congestive heart failure, unspecified HF chronicity, unspecified heart failure type Pneumonia due to COVID-19 virus COVID-19 Shock Syncope and collapse Discharge Diagnosis: COVID-19 Pneumonia Hospital Course:   Patient is a 54 year old male with past medical history of severe multivessel coronary artery disease S/p PCI April 2021 to LCx (previous PCI to LAD, uncontrolled diabetes mellitus type 2 (Hgb A1c 11.2), OSA, hypothyroidism, and recent diagnosis of COVID 19 presented to hospital with syncopal episode on 9/6. He reported he had had several syncopal episodes over past few weeks preceded by severe chest pain. Recent LHC 8/24/21- three vessel CAD with prior stent thrombosis, poor targets for revascularization. Echo 9/6- EF down to 32% from 44% in August. He did require 2L NC on presentation. Labs significant for sodium 128, Creat 0.64. Troponin 102 then increased to 668 then back down. He became hypotensive with concern for cardiogenic shock and he was started on norepi for MAP >65 and transferred to ICU for CTS evaluation for CABG. He was weaned off of vasopressors by AM 9/8. CTS stated patient not a CABG candidate due to distal CAD and COVID pneumonia. Transferred out of ICU 9/8.  He was started on dexamethasone and remdesivir for COVID pneumonia. He was hypotensive after transfer out of the ICU so unable to undergo diuresis or restart his home medications. Cardiology and Neurology felt that syncopal episodes were likely vasovagal in nature. Cardiology recommended medical management of CAD, LifeVest placed 9/10, repeat TTE in 3 months On CT thorax patient was found to have "A lobulated right lower paratracheal structure measures 2.5 x 3.2 cm and has gradually increased in size compared with 2009. This appeared to measure fluid density on the noncontrast portion of the comparison examination from 8/4/2017 and this may represent fluid in a pericardial recess or a bronchogenic/foregut cyst. However an abnormal mediastinal lymph node could also have this appearance. Recommend further assessment with MRI of the chest with and without contrast."  Will defer repeat imagine of this to PCP. PT evaluated the patient and recommended discharge home with outpatient PT. At discharge he is aware of 10 days isolation requirements for COVID-19, through 9/16 unless still having fevers. He has outpatient appointments established with PCP and Cardiology for follow-up.  Home ACE-I and IMDUR held at discharge for hypotension. He is encouraged to monitor BP at home and report to outpatient physicians. He has referral to outpatient cardiac rehab.  Diabetes followed through hospital stay and home medications were resumed at discharge.