chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician, via a company representative, and refers to a patient of unknown age and gender. Information about the patient's pertinent medical history, drug reactions/allergies and concomitant medications was not reported. On 28-NOV-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, "10PK-0.5mL SD-PFS-LLok wTip" which had the lot # K009874 with expiration date on 19-MAR-2016, (dosage number and route of administration were not reported). Nonetheless, no adverse effects were reported and no product quality complaint was involved. The vaccine experienced a temperature excursion of 9 C for 8 hours (highest recorded temperature). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". This is one of the several received from the same reporter. Additional information has been requested.
Vaccine Error administration due to patient age. 2nd booster administered to a 49 y/0 female.
Pain in arm From initial information received on 11/Dec/2003 from the patient, who is a nurse, regarding an adverse event occurring in U. S. A., it was reported that the 30-year-old female received a first dose of Fluzone SV 2003-2004 USP, lot number not reported, administered in the deltoid on 08/Dec/2003.  Within several hours (also reported as onset date of 10/Dec/2003), the patient developed arm soreness, which was described as becoming "very painful and tender with pain down the arm".  The patient reported that she took Advil for her symptoms.  Reportedly, the patient did not recover from thses events.  No other information was provided.
adipose necrosis 1x1cm <less;pt exp dimpling of thigh p/vax;dimpling is a result of necrosis of fatty tissue;
No additional AE; inadvertent administration of an expired dose of RECOMBIVAX HB; This spontaneous report was received from a pharmacist, referring to a 27-year-old patient with unknown gender. The patient's concomitant therapy, concurrent condition, medical history and drug reactions/allergies were not reported.  On 02-MAY-2023 (reported as today), the patient was inadvertently vaccinated with an expired dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (dose was 1 milliliter (ml), expiration date was reported as January 2023, lot number, route and anatomical location were not provided) for prophylaxis (expired product administered). The reporter inquired about inadvertent administration of an expired dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) and the potency of the dose. No adverse effects and no additional adverse event (AE) reported (no adverse event).
Vaccine given on Friday 1/8 at 10am. Started having significant fevers, chills, myalgias, rigors on 1/9 around 1pm. Symptoms lasted for about 8hrs. On 1/10 developed left upper arm, axillary, chest wall, and clavicular soft tissue swelling with significant lymphadenopathy. Lymphadenopathy was tender, multiple nodes ~2cm. Started experiencing severe sharp shooting pain and burning in similar region. On 1/11 started developing weakness in L arm and hand, with numbness in left hand. Went to urgent care on 1/11. Exam demonstrated 4/5 strength of left arm and hand. Started prednisone 40mg on 1/11. Swelling, pain, and weakness persisted. Seen in ER 1/15, exam with persistent weakness and lymphadenopathy. MRI brachial plexus performed which showed multiple enlarged nodes adjacent to brachial plexus. No overt inflammation or compression of brachial plexus. Received IV dexamethasone, and PO prednisone course. Finished 10d of prednisone 40mg with improvement in soft tissue edema, but still with residual weakness and pain. EMG pending. Diagnosed with brachial plexopathy secondary to compressive adenopathy from COVID 19 vaccine.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On 04-FEB-2016 the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB (incorrect product storage) (lot # L029631, expiry date 14-AUG-2017) (dosing regimen and frequency unknown) in the immunization series. No concomitant medications were reported. It was reported that the RECOMBIVAX HB experienced a temperature of minimum 1.64 degrees Centigrade to maximum of 8.36 degrees Centigrade for a 24 hours time frame. It was also reported that there was no previous temperature excursion. It was also reported that the nurse called to report because of a data logger. No adverse effects were reported. No product quality complaint was reported. The action taken with the therapy with RECOMBIVAX HB was unknown the outcome of the events was unknown. This is one of the two reports from the same source. Additional information has been requested.
Very tired like the Flu; Very tired/ Spent the day after the second vaccine in bed.; Body aches; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Very tired like the Flu), FATIGUE (Very tired/ Spent the day after the second vaccine in bed.), MYALGIA (Body aches) and HEADACHE (Headaches) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939906) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Very tired like the Flu), FATIGUE (Very tired/ Spent the day after the second vaccine in bed.), MYALGIA (Body aches) and HEADACHE (Headaches). At the time of the report, INFLUENZA LIKE ILLNESS (Very tired like the Flu), FATIGUE (Very tired/ Spent the day after the second vaccine in bed.), MYALGIA (Body aches) and HEADACHE (Headaches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided No treatment medication information was provided    This case was linked to MOD-2021-323655 (Patient Link).
breathless; Can't walk 5 steps; dry cough; chest pain; This is a spontaneous report from a contactable consumer (patient) reported for herself. A non-pregnant 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ER8729), via an unspecified route of administration, administered in Arm Left on 30Apr2021 12:00 (at age of 64 years old) as single dose for COVID-19 immunisation. Medical history included Diabetic, high blood pressure, known_allergies: Amocicillin, zestril, Peanuts. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. On 13May2021, The patient Can't walk 5 steps without breathless, dry cough, little chest pain. Serious was NO. The adverse event result in: Doctor or other healthcare professional office/clinic visit. No Treatment. The outcome of the events was Not recovered.
product=COVID 19 Treatment, brand=Paxlovid/vaccine brand=Pfizer / BioNTech; product=COVID 19 Treatment, brand=Paxlovid/vaccine brand=Pfizer / BioNTech; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "product=COVID 19 Treatment, brand=Paxlovid/vaccine brand=Pfizer / BioNTech". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Anti-viral details included Covid-19 treatment with Paxlovid started on 13May2022 and ended on 13May2022. Other medication in 2 weeks product was Plaquinel. Consumer woke up with a facial rash and swelling on 14May2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Syncopal episode after receiving vaccine. Adult emergency called. Pt awake and alert within 1-2 mins. To ACC for evaluation
a spreading significant very itchy rash  - face, torso, arms. No hands or feet. Dry, red, flat macular rash. Very chapped dry lips. Slight redness of vaginal mucosa. Mouth - slight white coating on tongue.  Significant discomfort because of itching, very tired. Not interested in eating  one transient temp 100.3  no eye involvement , no swollen lymph nodes.
My eyes are really burning and they are really red; My left eye looks like a little swollen; It's hard to for me to see; My eyes hurt; My eyes are really burning and they are really red; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 14Apr2022 as dose 4 (booster), single (Lot number: FK9895) for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: VISUAL IMPAIRMENT (non-serious) with onset 14Apr2022, outcome "unknown", described as "It's hard to for me to see"; EYE IRRITATION (non-serious), OCULAR HYPERAEMIA (non-serious) all with onset 14Apr2022, outcome "unknown" and all described as "My eyes are really burning and they are really red"; EYE PAIN (non-serious) with onset 14Apr2022, outcome "unknown", described as "My eyes hurt"; EYE SWELLING (non-serious) with onset 14Apr2022, outcome "unknown", described as "My left eye looks like a little swollen".  Additional information: The patient had 4th Pfizer booster shot. Patient came home and washed face and patients eyes were really burning and they were really red. Patient tried rinsing them out with water but nothing was helping and Patient left eye looks like a little swollen. So, Patient did not know if it was a possible side effect of the booster shot or not?" When paraphrased the concern, consumer stated, "Yes, that was I wanted to know and what to do about it?" Date of administration: Consumer stated, "Today at 2 o'clock." (Clarified as 14April2022).   No follow-up attempts are possible. No further information is expected.
This case was reported by a other health professional via call center representative and described the occurrence of anaphylactic reaction in a female patient who received FLUARIX QUADRIVALENT. On an unknown date, the patient received FLUARIX QUADRIVALENT. On an unknown date, an unknown time after receiving FLUARIX QUADRIVALENT, the patient experienced anaphylactic reaction (serious criteria GSK medically significant), hives, shortness of breath and wheezing. the patient was treated with epinephrine. On an unknown date, the outcome of the anaphylactic reaction, hives, shortness of breath and wheezing were unknown. It was unknown if the reporter considered the anaphylactic reaction, hives, shortness of breath and wheezing to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: the age at vaccination was not reported. the healthcare professional reported that the patient received a dose of FLUARIX QUADRIVALENT and then experienced an anaphylactic reaction, which was described as hives, shortness of breath, decreased blood pressure and wheezing. the patient was admitted to the ICU (Intensive Care Unit) and was given epinephrine. the healthcare professional had limited information for report.  the reporter refused to provide date of birth of the patient.
He suddenly totally lost his right hearing; A spontaneous report was received from a consumer concerning  a 59 years old male patient who suddenly had a total loss of his right hearing (deafness).  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included montelukast sodium, hydrochlorothiazide, atorvastatin, losartan potassium and potassium.  On 17 Feb 2021, at 4:45 PM approximately six days prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot: 030M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 23 Feb 2021, the patient suddenly totally lost his right hearing and patient went to emergency room (ER) and specialist doctors.   Treatment for the event included meclizine 25 mg, lorazepam 0.5 mg, amoxicillin 875-clavulanate 125 mg, prednisone 5 mg.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event of patient suddenly totally lost his right hearing was unknown.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
I have HSV-2 and have historically had outbreaks 1-2 times per year. 45 days since receiving the vaccine, I have had four outbreaks that have all been more severe than any I have had before
Large swollen lymph node in the left groin; Both breasts hurt terribly; Swollen lymph nodes in both armpits and sides of both breasts; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN620S) via an unspecified route of administration on 15Mar2021 at 11:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medication within 2 weeks of vaccination. On 16Mar2021, after receiving the second vaccine, the patient experienced that both breasts hurt terribly with swollen lymph nodes in both armpits and sides of both breasts. On 26Mar2021, she noticed a large swollen lymph node in the left groin which resulted in medical care including visits to her Primary Care Physician (PCP), a surgeon, an MRI, ultrasound and blood work. The events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. On an unknown date in 2021, the patient underwent MRI, ultrasound and blood work and the results were unknown. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events both breasts hurt terribly, swollen lymph nodes in both armpits and sides of both breasts and large swollen lymph node in the left groin were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Th pt received vaccines on 11/14/03 at 0935. On 11/15/03 developed fever of 101, which continued until 11/17/03 then went to 103 that morning. The pt was irritable and continued to have fever until 11/18/03. The pt was seen in our office on 11/17/03 and 11/18/03.
Right eye Central Retinal Artery Occlusion resulting in blindness in right eye.  Sight lost suddenly.  Hospitalized for stroke assessment.
Doses were administered after 24 hs of the first puncture of the vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were administered after 24 hs of the first puncture of the vial) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) 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 EXPIRED PRODUCT ADMINISTERED (Doses were administered after 24 hs of the first puncture of the vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were administered after 24 hs of the first puncture of the vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Relevant concomitant medications were not provided. Treatment information was not provided
He began feeling flush and shob and his heart was racing.  Then his throat got scratch and felt like it was closing.
Pain around injection area starting 4 hours post dose (2nd shot).; Headache starting 8 hours post dose(2nd shot) lasting 2 hours without any medication.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 29Mar2021 (Batch/Lot number: unknown) at the age of 48 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: 08Mar2021, when the patient was 48 years old, for COVID-19 immunisation.  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Mar2021, outcome "recovered", described as "Pain around injection area starting 4 hours post dose (2nd shot)."; HEADACHE (non-serious) with onset Mar2021, outcome "recovered", described as "Headache starting 8 hours post dose(2nd shot) lasting 2 hours without any medication.". Therapeutic measures were taken as a result of vaccination site pain. Therapeutic measures were not taken as a result of headache.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Permanent loss of vision in right eye three weeks after receiving first COVID 19 vaccination.  Diagnosed with Branch Retina Artery Occlusion (BRAO) clotting of the retinal artery. Emergency Room admittance and 4 day stay at Hospital at direction of Retina Specialist Dr.
Presented to ED w c/o rt sided cp & confusion; admitted for COVID-19 pna; tx w/abx, steroids; did not require O2; dc'd home
Patient received her 3rd of Hepatitis vaccincation injection while she was at dialysis and stated she got fever, chills, weakness. Came to Hospital and was admitted.
Pressure in chest; Dry cough; Chills; Pounding headache; Fever; Body aches; Tenderness, soreness in arm; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Pressure in chest), COUGH (Dry cough), MYALGIA (Body aches), VACCINATION SITE PAIN (Tenderness, soreness in arm) and CHILLS (Chills) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included DULOXETINE HYDROCHLORIDE (CYMBALTA) for an unknown indication.    On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE PAIN (Tenderness, soreness in arm). On 06-Feb-2021, the patient experienced MYALGIA (Body aches), HEADACHE (Pounding headache) and PYREXIA (Fever). On an unknown date, the patient experienced CHEST DISCOMFORT (Pressure in chest), COUGH (Dry cough) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, CHEST DISCOMFORT (Pressure in chest) outcome was unknown and COUGH (Dry cough), MYALGIA (Body aches), VACCINATION SITE PAIN (Tenderness, soreness in arm), CHILLS (Chills), HEADACHE (Pounding headache) and PYREXIA (Fever) had resolved.
burning sensation through my body; shakes; jitteriness; lightheaded; exhaustion; injection site redness and soreness; injection site redness and soreness; This is a spontaneous report from a contactable consumer (patient). A 40-years-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: EL9264 and Expiration date: unknown), via an unspecified route of administration, in left arm on 07Feb2021 (at the age of 40-years-old) as dose 2, single for Covid-19 immunization. Facility where the most recent covid-19 vaccine was administered was hospital. The patient medical history was not reported. Concomitant medication included escitalopram oxalate (LEXAPRO) taken for an unspecified indication, start and stop date were not reported. Historical vaccination included dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: EL3249 and Expiration date: unknown), via an unknown route of administration, in left arm on 17Jan2021 at 09:30 (at the age of 40-years-old) as dose 1, single for covid-19 immunisation and experienced injection site irritation. Patient had no allergies to medications, food or other products. The patient did not receive any other vaccine within 4 weeks prior to the covid vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 07Feb2021 (at 09:45), the patient experienced after 2nd dose burning sensation through her body followed by shakes and jitteriness and lightheaded. Then exhaustion. 2 days later still had injection site redness and soreness. The case was assessed as non-serious. It was reported that " Was treatment received for the adverse event: Unknown". Outcome of the events was resolved on an unspecified date in Feb2021.  Follow-up attempts are completed. No further information is expected.
12/11 sore throat, tested positive PCR 12/14 televisit with test results, advised to treat symptomatically. 12/12 cough, fatigue headaches, burning in esophagus and or trachea. These lasted 4 days, through the 15th and lingering fatigue and cough for an additional week through 12/22.
Pt felt throat tightening for 2 dasy got ince SOB was transported to ER; tx SQ EPI w/complete recovery;
Outbreak of chickenpox, spots on face, neck and leg. Advised to cut fingernails, apply Benadryl to spots and Aveeno Bath.
Diarrhea, nausea, chills, fatigue, muscle aches, headache. Fatigue and muscle aches are still occurring; chills, nausea, and diarrhea have passed. Took 2 Tylenol, and a hot shower helped muscle aches!