chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt brought via EMS to ED for SOB & chest pressure on deep breathing w/cough. Pt was hypoxic on room air at 82% but responded w/2L O2. Testing revealed mildly elevated lactic acid (2.5, likely due to metformin) and mildly elevated BNP (223) and a positive COVID test. UA showed some bacteria and leukocyte esterase, but no UTI symptoms. Pt had received both Pfizer vaccine (1/15/21 & 2/6/21). Was admitted for additional management of acute hypoxemic respiratory failure with COVID-19 due to oxygen needs.  Was treated w/dexamethasone, remdesivir and sepsis was ruled out. Ceftriaxone was given in ED for asymptomatic bacteruria.  Pt ultimately discharged 3 days later with pulse oximetry for home use.
Patient reported getting 2-3 dime-sized blisters on arm near injection site 24 hours after vaccination. Patient reported the blisters going away 24 hours after that with no intervention needed. Indicated to patient to continue to monitor the area, but most likely an acute reaction.
arm pit sore tender has a welt the injection site is red and irritated my ear is flaming red now also.
No energy; Pain in joints; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (No energy) and ARTHRALGIA (Pain in joints) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     The patient's past medical history included Cancer (Patient was a cancer survivor.). Concomitant products included METOPROLOL and VITAMINS NOS for an unknown indication.   On 19-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 an unknown date, the patient experienced ASTHENIA (No energy) and ARTHRALGIA (Pain in joints). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, ASTHENIA (No energy) and ARTHRALGIA (Pain in joints) outcome was unknown.            Concomitant products used included Vitamins, metoprolol and stomach acid medications.  The patient experienced Pain in joints and no energy after 4-5 days of second dose.  Action taken with mRNA-123 is not applicable.
Information has been received from a clinical medical assistant referring to a patient of unknown age and gender. The patient's medical history and concurrent condition were not provided. The patient was administered a dose of improperly stored GARDASIL 9 (lot L016428, with expiration date of 30-JUL-2017, dose and route not provided) on 16-DEC-2015. No adverse effect reported. Additional information has been requested.
Patient tested positive for COVID via abbott home test on 1-14-22 after receiving only the first of the two vaccinations in the series for pediatric patients. Patient never developed symptoms but was tested due to family members being sick and testing positive.
Administration of vaccine adjuvant suspension component (liquid) without active antigen (powder); Administration of vaccine adjuvant suspension component (liquid) without active antigen (powder); This case was reported by a physician via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 28-JUN-2022 and 29- JUN-2022 Reporter's Comments: The GlaxoSmithKline sales representative called GlaxoSmithKline response center the morning of 29th June 2022 to report that the previous day late in the day he was at a medical office and was shown a box of Shingrix. The box had 5 vials of the adjuvant missing.  The sales representative asked what happened to the vials.  The response that was given was that they were administered to 5 patients. No further information was gathered by sales representative such as lot number, patient's initials, patients genders, or route of administration. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up. Additional Supportive Information: The patient was administered vaccine adjuvant suspension component (liquid) without active antigen (powder) component which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This is 1 of the 5 cases reported by the same reporter. The case US2022AMR100447 was identified as duplicate of US2022101093. The case US2022101093 would be voided, and all the future correspondence would be added in this case US2022AMR100447 which stands as a case of record for this patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR100445:Same reporter US-GLAXOSMITHKLINE-US2022099857:Same reporter US-GLAXOSMITHKLINE-US2022AMR100449:Same reporter US-GLAXOSMITHKLINE-US2022AMR100452:Same reporter
This spontaneous report as received from a nurse refers to patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patients (eight) were vaccinated with GARDASIL injection (post temperature excursion) lot # K010574, expiration date: 08-APR-2017 (strength, dose and route unspecified). No concomitant medications were reported. No adverse effects were reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No further information was provided. Additional information has been requested.
This spontaneous report was received from a healthcare worker refers to a patient of unknown age and gender. On 10-JUL-2015 the patient was vaccinated with one dose of improperly stored oral, ROTATEQ (dose was not reported, route of vaccination was defaulted to oral, lot# K013661 with exp. date 26-MAY-2016). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: pain in left shoulder blade-Medium
pt recvd vax 25SEP92 & 31OCT92 exp sensation of tightening in arms during typing class; sx resolved w/in 30 mins of stopping the typing; exp tightening sensation in back, pain in hands, legs, back, knees, weakness in legs; h/a, hyperreflexi
Local reaction, flu-like symptoms x 72hrs, ache, light headed, fever, cold chills, trouble keeping warm, headache. Superior aspect of left tricep 3x5cm area of erythema and warm and tender to touch. Continue ibuprofen 800mg tid and heat to affected area.
EXAGGERATED STARTLE RESPONSE -MILD ADMITTED FOR OBSERVATION SECONDARY TO A FAMILY HISTORY OF SEIZURES.  THE PATIENT IS STABLE.  EEG PENDING
FEVER FOR 2 DAYS THAN NUMBNESS IN TOES,FEET,FINGERS FOLLOWED BY PROGRESIVE WEAKNESS IN LOWER EXTREMETIES.HOSPITALISED  11/15 FOR EXTREME WEAKNEESS,DIFFCULTY WALKING.
Uncontrollable shivering shaking almost like a seizure type. Severe headache, pain muscles, close throat dry throat. Tiredness fatigue.
Injection site hard; Injection site redness; Injection site swollen; Injection site soreness; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE INDURATION (Injection site hard), VACCINATION SITE ERYTHEMA (Injection site redness), VACCINATION SITE SWELLING (Injection site swollen) and VACCINATION SITE PAIN (Injection site soreness) in a 66-year-old female patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 16-Mar-2021, the patient experienced VACCINATION SITE INDURATION (Injection site hard), VACCINATION SITE ERYTHEMA (Injection site redness), VACCINATION SITE SWELLING (Injection site swollen) and VACCINATION SITE PAIN (Injection site soreness). At the time of the report, VACCINATION SITE INDURATION (Injection site hard), VACCINATION SITE ERYTHEMA (Injection site redness), VACCINATION SITE SWELLING (Injection site swollen) and VACCINATION SITE PAIN (Injection site soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and 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.   This case was linked to MOD-2021-046432, MOD-2021-046326 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow- up were received on 07-MAY-2021 and contains No new information.
I was tired and feeling run down. I thought maybe I just wasn't sleeping well. The night of July 6th, I started to feel achy, like if I was coming down with something. I went to get a PCR test and it was negative. 2 days later I was feeling fine, and then the day after, it all hit. I took a home COVID test and it was positive. I was congested and incredibly fatigued. I was trying to work but I had to sleep after every other. To this day I can only work very few hours before I have to lay down and nap. I work a desk job so I am not doing labor. The top part of my head feels like its to tight. I currently am experiencing still heavy fatigue and a headache even though I just recently tested negative again.
The evening after getting the flu vaccine, patient experienced night terror, restlessness, inability to walk and sore muscle at the site of injection. Her husband called 911 and she was admitted to the ER on the same night.
Had a lot of swelling at injection site for 3 days then the swelling went away but on 1-7-21 she developed more swelling and site was warm to touch, by 1-8-20 it was extremely swollen so she went to urgent care and was treated with antibiotic and Benadryl. The doctor referred to her reaction as a "drug eruption."
Shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th July 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 31st July 2020, 2 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had Shingles.  The patient gives consent to follow up with physician but unable to provide full contact information details.  The patient unable to provide lot number and expiration date. The reporter consented to follow up.
ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY HYPOTENSION RIGHT FACIAL MUSCLE WEAKNESS
Patient says that it felt like his pacemaker was shocking for roughly 20 minutes 5-6 hours after receiving the vaccine.  Since then he says he has been fine.
presents with a potential reaction to the COVID19 vaccine. The patient was found by an RN responder in-vehicle unresponsive with a closed airway. RN performed head tilt jaw thrust maneuver and patient's airway opened with the spontaneous return of consciousness. EMS was summoned to the vehicle and vitals were obtained. BP 158/94 P 77 SpO2% 98%. The patient rapidly returned to baseline with oral hydration and increased monitoring.
Positive Covid test; Persistent cough; Fatigue; Muscle ache; Headache; Low graded fever; Back Pain; Tightness of chest; A spontaneous report was received from a consumer concerning himself, a 47-year-old, male patient who experienced back pain, tightness of chest, persistent cough, fatigue, muscle aches, headache, low graded fever and a positive Covid test [SARS-CoV-2 test positive].   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 26-Dec-2020, a few hours prior to the onset of the symptoms, the patient received his first of two planned doses of mRNA-1273 (Lot 037K20A) intramuscularly in an unknown injection site for prophylaxis of COVID-19 infection.   A few hours after receiving the Covid-19 vaccine, the patient experienced side effects including persistent cough, muscle ache, back pain, tightness of chest, fatigue, headache and low graded fever (99.1F-100.1F).   He reported that the side effects were mild on 26-Dec-2020 (day of vaccination) but increased in intensity to severe on 27-Dec-2020 and 28-Dec-2020.   Treatment for the events included tizanidine for muscle aches.   Action taken with mRNA-1273 in response to the events was unknown.   The outcomes of the events were not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, the event of Covid-19 positive is Unlikely related to mRNA-1273 and a very limited information regarding this event  has been provided.  Further information has been requested
Was sore, swollen up for his shoulder to his elbow red and warm to the touch. When patient came into clinic for his 2nd dose is when he told us about the reaction.
Severe headache; fever; chills; nausea; fatigue; swollen injection site & pain; swollen injection site & pain; This is a spontaneous report from a contactable Consumer (patient). A 68-year-old non-pregnant female received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EN9581) via unspecified route of administration in left arm on 13Feb2021 at 7:30 (at the age of 68-year-old) as single dose for COVID-19 immunization. Medical history of the patient included Hypothyroidism. Patient received other medications (concomitant) in two weeks (unspecified). Patient did not receive any other vaccination within four weeks of COVID vaccination. No covid prior vaccination and no covid tested post vaccination. Patient previously took erythromycin for an unspecified indication and had allergy. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EL3249) in left arm on 23Jan2021 at 11:00 as single dose for COVID-19 immunization. On 14Feb2021, at 08:30 AM, patient experienced severe headache, fever, chills, nausea, fatigue, swollen injection site & pain. Patient did not receive any treatment for the events. Outcome of the events were recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Information has been received from a public health nurse concerning an 8 year old female who on 9/3/96 was vaccinated with a dose of varicella virus vaccine live (lot # MV87800). The reporter noted that the number on the bottle was MV87800, but the lot number was unknown. The reporter indicated that a school nurse told her that a vaccinated patient had chicken pox breakthrough. The mother of the patient called the school nurse on 2/5/04, stating that her daughter had been diagnosed with chicken pox by her primary physician. The patient had a high fever and chicken pox all over her body. Unspecified medical attention was sought and it was unknown if treatment was required. A product quality was not involved. Additional information was received from the public health nurse which indicated that a school nurse reported to the county health department that a third grade student was diagnosed by their primary doctor with chicken pox in January 2004. The patient had been previously vaccinated in 1996 with varicella virus vaccine live. The patient had a fever of 103 and according to the mother, was covered with chicken pox. No hospitalization was reported. Additional information has been requested.  Additional information was received from the school nurse which indicated that the patients mother called her at school to report that the patient had a high fever 104 and a rash on 2/05/2004. On 2/6/2004 the mother took the patient to the doctor and chickenpox was verified. Subsequently, the patient recovered. Additional information was received from a physician who indicated the patient missed school due to chickenpox. No further information is expected.
This spontaneous case was initially received on 05-Oct-2015. The case report was received from a Health Professional and concerns a female patient. The patient received AFLURIA on 30-Sep-2015 - unknown stop date, Batch no: 11449221A, Route of administration: Intramuscular, Site: Triceps muscle. No additional drugs suspected. On 30-Sep-2015, the patient experienced received the AFLURIA vaccine in the triceps muscle. The reporter denies any patient harm. Reporter's assessment: not reported.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Fever-Medium, Systemic: Nausea-Mild, Systemic: Unable to Sleep-Medium, Systemic: Vomiting-Mild, Additional Details: patient went to ER, and they gave antibiotic, but lead to other blood clot side effect
Patient presented to ED on 04/25/2021 with complaints of abdominal pain, abdominal distension, and AMS.  Patient was admitted to ICU with following diagnoses: 1) Septic Shock, 2) A/C hypoxic/hypercapnic respiratory failure, 3) Acute metabolic encephalopathy, 4) Palliative care patient, 5) AE COPD, 6) ARF w/ATN on CKD3, 7) CAD, 8) Chronic sys/dia CHF, 9) Malnutrition/Failure to thrive.  Patient died on 04/26/2021 at 1826.   Patient was also previously admitted to hospital on 03/23/2021-03/29/2021 for sepsis.
Experiencing 3 lymph nodes near left collar bone; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 27Apr2021 (at the age of 28-year-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any concomitant medication. On an unknown date in 2021, after taking the vaccine, the patient was experiencing 3 lymph nodes near the left collar bone. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event experiencing 3 lymph nodes near left collar bone was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Swelling, redness, pain in immunized arm. MD advised to apply ice and take BENADRYL.
Told to wait 90 days for my 2nd dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (Told to wait 90 days for my 2nd dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Developed symptoms) on 05-Apr-2021.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Told to wait 90 days for my 2nd dose). At the time of the report, INTENTIONAL PRODUCT USE ISSUE (Told to wait 90 days for my 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment medications were unknown.  The patient received monoclonal antibody treatment on 16-APR-2021. The patient was told to wait 90 days for second dose.
None, Pt should have received flu Vac.  Pt is fine and was notified.
This spontaneous report was received from a nurse, who was also the patient's sister and refers to a female patient of an unknown age. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were unknown. On 16-SEP-2016, the patient was vaccinated with a dose of ZOSTAVAX injection, subcutaneously in "the underside of her arm instead of the deltoid" (dose, lot number and expiration date were not reported). The vaccine was administered by a pharmacist. On an unknown date in September 2016 (reported as after an unspecified amount of time), the patient experienced swelling and redness at the injection site resolved. The patient did not seek medical attention. It was unknown if any lab diagnostic studies were performed. No treatment was given for the events. The reporter stated that symptoms "lasted for an unspecified duration of time" but did not specify if swelling and redness at the injection site resolved. The call was disconnected before further information could be obtained. The outcome of the events was considered unknown. The relatedness between swelling and redness at the injection site and vaccination with ZOSTAVAX was not reported. Additional information has been requested.
Anthrax shots #2, 4 localized abscess with surrounding erythema, required I & D. No reaction with 1,3.
This case was reported by a physician via sales rep and described the occurrence of erythema of extremities in a 4-year-old male patient who received FLUARIX QUADRIVALENT. On 13th October 2017, the patient received FLUARIX QUADRIVALENT. In October 2017, less than a week after receiving FLUARIX QUADRIVALENT, the patient experienced erythema of extremities and skin warm. The patient was treated with BENADRYL (nos). On 16th October 2017, the outcome of the erythema of extremities and skin warm were recovered/resolved. It was unknown if the reporter considered the erythema of extremities and skin warm to be related to FLUARIX QUADRIVALENT. Additional details were reported as follows: The patient received FLUARIX QUADRIVALENT in right arm and experienced localized redness at the injection site. The redness then continued to spread form the top of the patient's shoulder to the elbow, covered 3 by 4th of the patient's arm and was hot to touch. The affected area was outlined with a marker by the healthcare professional and the area and the area continued to grow. The patient used BENADRYL as treatment. On 15th October 2017, the patient was seen in the emergency department where the patient was given BENADRYL and discharged.
Patient had COVID-19 with pneumonia at the end of December 2020 and recovered.  Received vaccine in mid February and 2nd dose of vaccine on March 3rd.  Presented to the emergency department on the night of March 4th from correctional facility where she is incarcerated because of fever over 103 and lethargy/confusion and tachycardia of 115.
Severe headache and chills after vaccine up to 24 hours. Severe headache remained up to 55 hours. Stomach upset and vomiting (x1) started at 55 hours and continued through 68 hours (present time). Treated with ibuprofen alternating with tylenol for 50 hours. Meds were taken after eating.