chrisvoncsefalvay/vaers-outcomes huggingface dataset:
barely got out of bed; temperature of 101.5 degrees Fahrenheit; fatigued; muscle aches; headaches; felt great till night time; freezing cold to really hot; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt great till night time), FEELING OF BODY TEMPERATURE CHANGE (freezing cold to really hot), FEELING ABNORMAL (barely got out of bed), PYREXIA (temperature of 101.5 degrees Fahrenheit) and FATIGUE (fatigued) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included AMLODIPINE for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced FEELING ABNORMAL (felt great till night time), FEELING OF BODY TEMPERATURE CHANGE (freezing cold to really hot), PYREXIA (temperature of 101.5 degrees Fahrenheit), FATIGUE (fatigued), MYALGIA (muscle aches) and HEADACHE (headaches). On 25-Mar-2021, the patient experienced FEELING ABNORMAL (barely got out of bed). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 1 dosage form. On 24-Mar-2021, FEELING ABNORMAL (felt great till night time) had resolved. At the time of the report, FEELING OF BODY TEMPERATURE CHANGE (freezing cold to really hot), FEELING ABNORMAL (barely got out of bed), PYREXIA (temperature of 101.5 degrees Fahrenheit), FATIGUE (fatigued), MYALGIA (muscle aches) and HEADACHE (headaches) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.5 (High) 101.5.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included paracetamol.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow up information was received as telephone contact report on  11 May 2021 wherein patient date of birth and event outcome was updated.
Day 1 on 02/15/2023, I just felt off and had a mild headache. Day 2, I woke up totally congested and my head hurt so much and my throat hurt. I talked to my provider on day 1 and started PAXLOVID. After that, I felt bad for days 2 and 3 and started feeling better. Then I had a rebound and was positive for 20 days.
COVID Breakthrough  Moderna 1 2/16/21 (012M20A) Moderna 2 3/12/21 (010A21A) Moderna 3 10/25/21 (047C21A) COVID Positive 11/7/21  11/7/21: Patient is a pleasant 77-year-old white female with COPD, non oxygen dependent who was doing well until 6 days ago when she developed dyspnea.  She has had pneumonia many times in the past.  She felt this was due to pneumonia.  She saw her primary care provider was given azithromycin.  She typically what is given steroids and she was not given steroids and she thinks that is why she is here today because she is more dyspneic today.  No fever, no pain, no cough.  Just the dyspnea.  No palpitations.  No ill contacts.  She was seen in the ER and she was hypoxic to 77% on room air.  Chest x-ray with possible bibasilar pneumonia.  CT scan to rule out PE protocol with no overt PEs but right basilar pneumonia.  She was given Levaquin IV. She was given Solu-Medrol.  And then she became COVID positive on her test was given a written for Decadron remdesivir which she will get as an inpatient.  The troponin I EKG were benign.  White blood cell count was benign.  So overall the test came back fine set she is COVID positive and she has hypoxic secondary to the same and she is being admitted for remdesivir, supplemental oxygen and Decadron as well as Levaquin for possible bacterial component to her pneumonia, hypoxia.  11/11/21: Discharge Summary Plan Discharge Status: improved. Discharge disposition: discharge to home self care. Prescriptions: continue same medications, reviewed with patient.
Injection site reaction. Redness, swelling and pain in left arm. Tylenol used. Swelling and redness has gone away, and patient still unable to sleep on left arm due to pain.
This spontaneous report was received from a license vocational nurse and refers to an unknown number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored ROTATEQ (dose, route of administration, lot number and expiry date were not reported). No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
patient woke up at 3am, and had an apparent seizure.  ambulance was called and patient taken to the emergency room for observation.  patient has no recollection of falling and having seizure.
1pm Pt reports not feeling well. Pale and diaporetic sitting in chair in OBS area. HX HTN No PSH and po BB at night.  Verbal and expressive.  Unresponsive for appx 5 sec and regained without assistance. EMS activated. VS brady 106/63 P 48 Pt reported did not eat, just closed on home and going to close on another home at 2 pm Pt wife is preg and due next month.    BP 127/83 verbal, tolerated water and no deficits noted.    Amb to personal car.  Wife driving and instructed to let medical know next dose to lay down prior to vaccination.  No direct adverse reaction noted to the vaccine, FNP
Lg erythematous plaque with induration distal Left deltoid, lat triceps area, is tender - 15cm x 8cm.
received expired vaccine; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number 7P5J5, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th October 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 14th October 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 14-OCT-2022 Reporter's Comment: The reporter was medical assistant. The reporter called to report that, a patient received an expired Kinrix vaccine at the time of reporting. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.  Additional Supportive Information: The patient received an expired Kinrix vaccine, which led to expired vaccine used.
Red generalized rash over upper and lower extremities, face, neck, hands and groin.  Began several hours after injection.  Patient had difficulty breathing and went to the ER early Wednesday morning.  Was given a prednisone pack and sent home.
Friday 8/12, felt very tired & slept off & on till noon - small amount of activity from 1PM-4PM left me exhausted & slept till 7PM. Ate dinner 745 & back to bed 8PM. Slept till 10:45PM & woke up very short of breath - used nebulizer albuterol, 11PM vomited - B/P 99/64, Pulse 105, Pulse ox 92 - 1230AM 8-13 paramedics came - B/P 150/90 wheezing - transport via ambulance to hospital ER at 1AM 8-13-2011.
Varicella administered 8/7/12. Today site is reddened 5 cm area. Warm to touch, itches. To use cool compress, BENADRYL.
Bled after the shot; This spontaneous case was received on 15-Sep-2020, from Med Communications (reference number: SEQW20-01722), reported by other health professional and concerned a female patient of unreported age.   The patient's medical history and concomitant medications were not reported.  On 19-Aug-2020, the patient was vaccinated with Fluad Quadrivalent [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: 0.5 ml, route of administration: intramuscular, anatomical location: not reported] as a prevention of seasonal influenza. The batch number was not reported.  On an unspecified date, after receiving Fluad Quadrivalent, the patient bled after the shot. It was reported that the patient did not experience any other adverse event besides bleeding after the injection.  At the time of initial reporting on 15-Sep-2020, the outcome of the event was not reported.   The event hemorrhage' was considered to be medically significant by a Physician within Seqirus's Pharmacovigilance and Risk Management Department.  The reporter did not provide a causality assessment.  This case is linked with the case 202004615 (same reporter).  Company comment: The patient developed haemorrhage on an unspecified date after vaccination with the suspect product, Fluad Quadrivalent. Chronology is unclear. No information about medical history and concomitant medications was provided. Considering all above mentioned, causal relationship for the event of haemorrhage is assessed as unassessable, due to the lack of information regarding event onset date and type of bleeding.; Sender's Comments: The patient developed haemorrhage on an unspecified date after vaccination with the suspect product, Fluad Quadrivalent. Chronology is unclear. No information about medical history and concomitant medications was provided. Considering all above mentioned, causal relationship for the event of haemorrhage is assessed as unassessable, due to the lack of information regarding event onset date and type of bleeding.
Headache, Myalgia, Injection site soreness and back shoulder pain Narrative:
Her arm was swollen and raised at the site of injection (deltoid) and there was also a bruise the size of a small marble. The swelling was more significant than her previous vaccinations of the same vaccine. It was sore the day of the injection but noticed the large raised area the next morning. She was evaluated by a provider and no treatment was needed but patient was instructed to report back if swelling/pain did not resolve.
Got the flu shot. Had swelling in arm, red , and was sore for over 3 days. Was sick for 2 days after shot. Throut felt funny like it was trying to swell shut.
My arm was sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (My arm was sore at the injection site) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INJECTION SITE PAIN (My arm was sore at the injection site). At the time of the report, INJECTION SITE PAIN (My arm was sore at the injection site) outcome was unknown.            No concomitant medications were reported.   No treatment medications were reported.   This case was linked to MOD-2021-278948 (Patient Link).   Reporter did not allow further contact
injection site large; Shingles; This non-serious case was reported by a consumer and described the occurrence of injection site swelling in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pruritus (on 12th July, 2023 received 1st dose, reference case US2023131685). Concurrent medical conditions included hypertension and cholesterol. Concomitant products included amlodipine, atorvastatin, finasteride, tamsulosin and losartan.   On 22-SEP-2023, the patient received the 2nd dose of Shingrix. On 23-SEP-2023, 1 days after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles). On 25-SEP-2023, the patient experienced injection site swelling (Verbatim: injection site large).  The outcome of the injection site swelling was not reported and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the injection site swelling and shingles to be related to Shingrix.     It was unknown if the company considered the injection site swelling and shingles to be related to Shingrix.   Linked case(s) involving the same patient:  US2023131685   Additional Information: GSK receipt date: 25-SEP-2023 The patient had the site was as large as a silver dollar. The (Shingles) symptoms were treated. The reporter consented to follow up. The case is linked with US2023131685, by same reporter.; Sender's Comments:  US-GSK-US2023131685:Original Case : US2023131685 US-GSK-US2023131685:Original Case : US2023131685 US-GSK-US2023AMR136610:2nd dose case
LEFT SHOULDER STARTED HURTING ON THE FOLLOWING THURSDAY MORNING, WAS IN UPPER CHEST AREA BY THE  SAME EVENING.  FOLLOWING MORNING INCREASE IN TEMPERATURE.  TOOK TO EMERGENCY ROOM  FRIDAY EVENING, DIAGNOSED WITH PNEUMONIA.  LEVAQUIN PRESCRIBED. SATURDAY COVID19 TEST NEGATIVE. INCREASE IN CHEST DISCOMFORT NEXT FEW DAYS, NO TEMPERATURE.  TEMPERATURE OVER 99 AGAIN ON 1/26/2021, TOP PORTION OF CHEST, NECK AREA HURTING, WOKE AT 10:30 PM COMPLETELY DRENCHED.  1/27/2021 AM FEELING A LITTLE BETTER.
Tenderness in muscles (upper extremities and lower), as if though I was going to get a cramp.
Dizziness for approximately 30 minutes, flushed, erythema on head, trunk and arms x 2days, and severe headache x 2days.
Red at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red at injection site) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red at injection site). On 31-Mar-2021, VACCINATION SITE ERYTHEMA (Red at injection site) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medications were mentioned. No treatment drugs were reported.   This case was linked to MOD-2021-114382 (Patient Link).
Weakness and fainted twice, losing consciousness; At about 09:00 on 03/09/2023, reported to Hospital Emergency Department and admitted to the hospital on 03/09/2023
Swelling, pain especially painful the 1st night, urinating every hour. Swelling started at the top of arm but has moved down to elbow and hand.
Developed fever 10 hours after injection that peaked at 103.0  about 15 hours after injection accompanied by sore left arm, body aches and chills. No nausea. Mitigated fever with Acetaminophen. Fever gradually reduced to normal at about 45 hours after injection.
Light sensitivity; Arm pain; Throat itching; Acid reflux like sensation in his throat; This spontaneous case was reported by a consumer and describes the occurrence of PHOTOPHOBIA (Light sensitivity), PAIN IN EXTREMITY (Arm pain), THROAT IRRITATION (Throat itching) and GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux like sensation in his throat) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 027B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced PHOTOPHOBIA (Light sensitivity), PAIN IN EXTREMITY (Arm pain), THROAT IRRITATION (Throat itching) and GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux like sensation in his throat). On 28-Apr-2021, PHOTOPHOBIA (Light sensitivity), THROAT IRRITATION (Throat itching) and GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux like sensation in his throat) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm pain) had not resolved.            No concomitant medications were reported.   No treatment information was provided.
very tired; unsteady; weak; felt strange on inside of mouth; upper lip, sinus and eyelid swelling; upper lip, sinus and eyelid swelling; inner nose felt funny; could not read due to double vision; strange metallic taste in mouth; rash all over upper body /blotchy skin on face / neck / upper chest / arms / upper back, pimples on face; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (unsteady), ASTHENIA (weak), FEELING ABNORMAL (felt strange on inside of mouth), LIP SWELLING (upper lip, sinus and eyelid swelling) and SWELLING (upper lip, sinus and eyelid swelling) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy and Allergic reaction to bee sting.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced GAIT DISTURBANCE (unsteady), ASTHENIA (weak), FEELING ABNORMAL (felt strange on inside of mouth), LIP SWELLING (upper lip, sinus and eyelid swelling), SWELLING (upper lip, sinus and eyelid swelling), NASAL DISCOMFORT (inner nose felt funny), DIPLOPIA (could not read due to double vision), DYSGEUSIA (strange metallic taste in mouth) and RASH (rash all over upper body /blotchy skin on face / neck / upper chest / arms / upper back, pimples on face). On 11-Apr-2021, the patient experienced FATIGUE (very tired). On 11-Apr-2021, FATIGUE (very tired) had resolved. On 12-Apr-2021, GAIT DISTURBANCE (unsteady), ASTHENIA (weak), FEELING ABNORMAL (felt strange on inside of mouth), LIP SWELLING (upper lip, sinus and eyelid swelling), SWELLING (upper lip, sinus and eyelid swelling), NASAL DISCOMFORT (inner nose felt funny), DIPLOPIA (could not read due to double vision), DYSGEUSIA (strange metallic taste in mouth) and RASH (rash all over upper body /blotchy skin on face / neck / upper chest / arms / upper back, pimples on face) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  The patient reported that she was getting better. She wanted to know if there is a blood test to check if she has the immunity and if she could get the second dose if she takes an EpiPen (epinephrine) with her.  No treatment information was reported.  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. Additional information has been requested.; Sender'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. Additional information has been requested.
Hives: 30% of body. Brutal itching. Never had them before. No known allergies. No hay fever. No asthma ever. Treatment with prednisone and Benadryl still ongoing as I report.
Soreness of the left arm; Missed second Dose ( Beyond day 42); This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness of the left arm) and PRODUCT DOSE OMISSION ISSUE (Missed second Dose ( Beyond day 42)) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METOPROLOL and QUETIAPINE FUMARATE (SEROQUEL) for an unknown indication.    On 08-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 PAIN IN EXTREMITY (Soreness of the left arm) and PRODUCT DOSE OMISSION ISSUE (Missed second Dose ( Beyond day 42)). At the time of the report, PAIN IN EXTREMITY (Soreness of the left arm) and PRODUCT DOSE OMISSION ISSUE (Missed second Dose ( Beyond day 42)) outcome was unknown.        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.   Treatment medication was not provided.
This spontaneous report was received from a 58 year old female patient reporting on herself without pertinent medical history, drug reactions or allergies. On 26-SEP-2014 the patient was vaccinated with ZOSTAVAX (dose, lot # and route of administration were not reported). Concomitant therapies included NEXIUM, loratadine (manufacturer unknown), zolpidem tartrate (manufacturer unknown) and MAXALT. On 26-SEP-2014, the patient experienced redness, swelling, warmth and itchiness at the injection site after receiving ZOSTAVAX. Patient stated that the redness at the injection site turned to a light brown color on unknown date in 2014 (reported as sometime over the last week). She reported that the light brown color at the injection site had a birthmark appearance. Patient did not receive any treatment for the adverse events. She sought medical attention and saw the pharmacist on 08-OCT-2014. There were not laboratory studies performed. The outcome of redness at the injection site was unknown. The outcome of itchiness, swelling and warmth at the injection site was reported as recovered/resolved on unknown date in 2014 (reported as within the first week after receiving ZOSTAVAX). Additional information has been requested.
-RASH ON LEFT THIGH, 1-2 INCHES NEXT TO INJECTION SITE(RED RAISED) -99 TEMP -MANY LEFT GROIN LYMPH NODES ENLARGED AND PAINFUL  -HEADACHES FOR 3 DAYS FOLLOWING -STIFF, SORE NECK -PALPITATION 3-5 TIMES AVG DAILY FOR 5-10 MIN HEART RATE 102-120.  VARIOUS TIMES IN THE DAY.   -SOB/"HEAVY BREATHING" WHEN HAVING PALPITATIONS -ARRYTHMIA NOTICED ON OCCASION WITH PALPITATIONS
The patient presents with chest pain.  The onset was 12  hours ago.  Radiation none.  Movement none.  Associated symptoms: none.  The course/duration of symptoms is constant.  Location: Left anterior chest. The character of symptoms is sharp and stabbing.  The degree at onset was moderate.  The degree at maximum was moderate.  The degree at present is moderate.  Exacerbating factors consist of none.  The relieving factor is none.  Prior episodes: angina.  Additional history: 57-year-old female presents ED with chief complaint of chest pain.  Patient states began roughly 12 hours ago.  Located left side of chest.  Sharp in nature.  It is also stabbing.  It does not radiate.  It is made better by nothing.  It is made worse by nothing.  Denies any fevers or chills but states she was told she had a fever when she checked into the emergency department.  Denies any numbness or tingling.  Patient states she had a "heart attack in January. "  Patient states she has been seen in the hospital numerous times for chest pain but everything is been negative.  Review of records show that it was June when the patient was seen and had stents placed.  Denies any urinary symptoms.  Denies abdominal pain.  No other complaints at this time. 7/31/2021 tested positive 8/6/2021 patient discharged.
6-6 = Bilat swelling thighs-blisters Rt thigh x 3-4 and bilat inj adenopathy, temp 100.6, added f/u Dr at the 13th  = reported increased LNS.