chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Having a fever of 101 towards the end of second day; This is a spontaneous report from a non-contactable consumer, the patient. A 26-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date at the age of 26-years-old and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01May2021 at 15:15 at the age of 26-years-old as a single dose for COVID-19 immunisation. The medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The concomitant medications were not reported. On an unknown date, towards the end of second day the patient had fever of 101. On an unknown date, the patient underwent body temperature test and the result was 101 (unspecified units). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event fever was unknown at the time of this report.    No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Patient became dizzy, lightheaded, and passed out less than 2 minutes. States he does this every time he receives any injections of any kind or has blood drawn. Aroused easily and was able to ambulate with no distress stayed in clinic until 1330. Provider notified, and patient allowed to leave clinic.
This spontaneous report was received from a nurse prescriber and  refers to a 15-year-old male patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 10-OCT-2018, the patient was vaccinated with an improperly stored dose of VARIVAX lot # N032744, expiration date 20-NOV-2019 (dose, route of administration were not reported). The vaccine was reconstituted with properly stored sterile diluent (STERILE DILUENT). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion between 15 to 46 degrees Fahrenheit for 2 hours and 57 minutes. Data logger was not involved. There were no previous excursions reported. No product quality complaint was involved. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1810USA007033:
pain at the site of injection which radiates/site of injection is still warm and painful; warmth is located mid position/site of injection is still warm and painful; body aches; chills; malaise; tiredness; hot flashes; temperature as high as 101.; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix with an associated reaction of pyrexia (received 1st dose on unknown date, refer case US2020148012).   On 19th July 2020, the patient received the 2nd dose of Shingrix (intramuscular). In July 2020, less than 2 weeks after receiving Shingrix, the patient experienced injection site warmth, general body pain, chills, malaise, tiredness, hot flashes and fever. On 19th July 2020, the patient experienced injection site pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain and injection site warmth were not recovered/not resolved and the outcome of the general body pain, chills, malaise, tiredness, hot flashes and fever were unknown.   It was unknown if the reporter considered the injection site pain, injection site warmth, general body pain, chills, malaise, tiredness, hot flashes and fever to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in her left deltoid and within 6 hours she started to have pain at the site of injection which radiates.  The pain and warmth was located mid position between the elbow and shoulder around the site of the injection.  The site of injection was still warm and painful.  The patient also reported body aches, malaise, tiredness, hot flashes, chills, and temperature as high as 101. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020148012:same reporter US-GLAXOSMITHKLINE-US2020148012:Same patient
Sleepless night with headache along margin of frontal cortex. Lethargic and weak. Possibly slight fever ( did not measure). Achy muscles. Muscles soreness around injection site on left deltoid. Soreness contributed to sleepless night. All symptoms but soreness at injection site were gone by evening of that day (1 day of symptoms). Very similar symptoms with 1st dose.
pt recv vax & devel breakthrough chickenpox that consisted of greater than fifty lesions & taken to ER;this was considered to be an other important medical event;
2 inch diameter firm lump under skin persisting for about 5 days, started about a week after shot.
neuropathy in both feet; I had muscle aches; tired; This is a spontaneous report from contactable consumer (patient).   A female patient of unspecified age received first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot Number: not reported) via unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. Medical history included patient had COVID-19, prior to vaccination and received the vaccine 3 months after COVID. Concomitant medication was not reported. On an unspecified date, patient had muscle aches and tired and one week after vaccination, started with neuropathy in both feet. The outcome of events was resolving.  Information on the lot/batch number has been requested.
Information has been received from an RN concerning a 17 month old white female who on 10/29/01 was vaccinated with a 1st dose of MMRII, IM, in the left thigh (lot 636393/0016L). On 11/9/01, the pt developed lymph node enlargement in the groin area. The pt had 2 enlarged lymph nodes in the left groin. One of the lymph nodes was 1 to 1 1/2cm in diameter and the other was about 8mm in diameter. There was a single enlarged node in the right groin about 1cm. The pt sought unspecified medical attention. Subsequently, the pt recovered. The date of recovery was reported to be unknown. No additional information is expected.
Hospital Course and Significant Findings: 81 Y male presented to ED with weakness, found  COVID positive not meeting criteria for Covid medications nor O2 requiring, noted tarry stools and hypotension on admission and in ICU for close observation.  Endoscopy for upper GI bleed revealed duodenal ulcers. One reported small bright red blood stool last evening, black smear this AM per RN. Patient received 2 units packed red blood cell transfusion. Hemodynamically stable. Tolerated diet. BID PPI started. Avoid NSAIDs. Will follow up path and H pylori if positive to treat as outpatient.  Mild Covid disease. No respiratory issues. Will quarantine for 10 days from 11/21/21 when felt weak.
Severe behavior change. Extremely hyper, argumentative, uncharacteristically aggressive, using lots of gibberish, excessive crying, excessive tiredness.
Swelling at injection on Tuesday. Then Wednesday, fluid pouch, had slight fever to touch, swelling from injection to the elbow. Thursday AM, a fluid pouch developed on the inside of the right arm elbow today, swelling (pouch) decreased somewhat. No pain; only slight itching at injection site.
sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore left arm) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No medical history was provided.     On 10-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 IN EXTREMITY (sore left arm). At the time of the report, PAIN IN EXTREMITY (sore left arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use includes Blood pressure medication and Cholesterol medication  No treatment information was provided   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Received report on 04-JUN-2021 and does not contain any new information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
1-23-02, Mom presents child with splotchy hand red spots @ varivax injection site given on 1-11-02 On 2-7-02, mom called to report the child has rash @ injection site, Requested mom to bring child in to have rash evaluated. Mom did not come for follow-up 2-8-02, mom called to report child was better.
RECEIVED PFIZER-BIONTECH (NDC 59267-1025-04) INSTEAD OF INTENDED BIVALENT (NDC 59267-0304-02)
Received full booster dose instead of half dose; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL OVERDOSE (Received full booster dose instead of half dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    In August 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, the patient experienced ACCIDENTAL OVERDOSE (Received full booster dose instead of half dose). In August 2021, ACCIDENTAL OVERDOSE (Received full booster dose instead of half dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Patient had taken several PCR tests, and all results have been negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were provided.   Reporter did not allow further contact
Hospitalized (1.2.22 - 1.3.22);  COVID-19 positive (1.2.22; historically positive 8.18.21); fully vaccinated PLUS booster Admission Date: 1/2/2022 Discharge Date: Jan 3, 2022 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Left-sided weakness [R53.1] Acute nonintractable headache, unspecified headache type [R51.9] COVID-19 [U07.1] HOSPITAL COURSE: 51-year-old female with a past medical history significant for bipolar disorder as well as history of migraines in addition to previous CVA with residual left-sided deficits presents to the hospital after suffering acute onset migraine with development of left-sided weakness and speech difficulty. In the emergency department, after CT of the head and CT angiography of the head and neck showed no evidence of acute process, consideration was had for tPA use after discussion with tele Neurology.  However, after reviewing the patient's chart, the providers in the emergency department did not strongly suspect an acute cerebrovascular accidents and did not believe that tPA was necessary.  Neurology did recommend observation with MRI to look for evidence of an acute cerebrovascular accident.  Patient was admitted to the hospital. Patient stated that her symptomatology had improved after being admitted to the hospital.  She had no residual speech deficits and stated that her left-sided weakness was still present but overall improved.  She has had similar presentations to this in the past with negative workup.  At this time, based on her presentation, it was suspected that she was suffering from a complex migraine with atypical symptoms in the form of left-sided weakness.  The patient to go for MRI of the head which showed no acute process.  At this point, as the patient was enquiring as to discharge, she was thought to be appropriate discharged home on 01/03/2022.  Suspicion was that she was suffering from an atypical presentation from her complex migraine with unmasking of her previous symptomatology as she states that she does have a history of CVA with residual left-sided deficits.
This patient was seen in the ER and hospitalized on 4/24/21 after syncope, and was found to have hypoxia and fever. NP specimen for SARS-CoV-2  was positive by PCR  Cycle Threshold was 15.4  We are trying to get whole genome sequencing done on the specimen. This appears to be a new COVID-19 case after being fully vaccinated. This is the reason for reporting. She is stable and may be discharged in the next day or two.
Headache, body aches, nasal congestion (no runny nose - had to blow it out), phlegmy cough, loss of appetite and taste, profuse sweating, tired and sleepy.  Symptoms lasted seven days but got progressively better by the fifth day.  I had to use my Albuterol inhaler more than I usually do.  I still have some very mild chest and nasal congestion.
Starting 10/31 evening runny nose and cough, continuing until 11/2 when High Fever (102 F with Tylenol), Chills, Chest Congestion, Runny Nose, Severe Cough
Headache, Myalgia, Fever, Tachycardia, Fatigue, chills, swollen right axillary lymphnodes Narrative:
After I read out the signs of severe allergic reaction. Caller mentioned her daughter had some but not all of them; her lips turned blue; light headache; incoherent; This is a spontaneous report from a contactable consumer (patient's father) reported for his daughter via medical information team.  A 14-year-old female patient BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number, and expiration date: Unknown), via an unspecified route of administration on an unknown date (at the age of 14-year-old) as 1st dose, single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. She received the first dose of the Pfizer COVID-19 vaccine three weeks ago and was due to receive the second dose next day. She had a severe reaction to the first dose. she had the first COVID-19 vaccine dose, she had a pretty severe reaction to it, that passed after 15, 20 minutes but just want to make sure that still get the second shot which was scheduled for tomorrow. Reporter stated, patient got her first shot for the first fifteen minutes, her lips turned blue, she got really light headache, become slightly incoherent, then after about 15, 30 minutes those symptoms went away, and she was ok. Reporter wants to know whether she could get her second dose and asked what the signs of a severe allergic reaction are. Consumer read out the signs of severe allergic reaction and mentioned her daughter had some but not all of them. Reporter did not specify any seriousness. The outcome of the events was resolved.  Information about batch/lot number has been requested.
This spontaneous report was received from a nurse and refers to multiple unspecified patients of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant therapies was provided. On unspecified dates in October 2015, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L001312 and expiration date 24-FEB-2017; lot # L007560 and expiration date 15-JUN-2017; lot # L013429 and expiration date 21-JUL-2017; exact doses and route of administration were not reported). No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
Received a vaccine which was more than 30 days in the refrigerator; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received a vaccine which was more than 30 days in the refrigerator) in a 61-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received a vaccine which was more than 30 days in the refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received a vaccine which was more than 30 days in the refrigerator) 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.   No concomitant medications information was reported. No treatment medications were provided.  Vaccines were stored more than 30 days in refrigerator, 30th day was on 03-Jul-2021
As with when given the COVID shot and booster shots, within 5-7 days I break out in hives on upper body and face area
Pharmacist working Monday 2/14 Noticed that the beyond use date for current batch of vaccines was 2/12/22. This vaccine should not have been used in the patient.
Redness, itchiness, swelling, pain at injection site, joint stiffness, burning, bruising - did not deem it severe enough to seek treatment but got this link through text so decided to report it here.
15 days after taking 2nd dose of Pfizer vaccine I noticed a scab on my lip and my face around my mouth got itchy. I?ve had cold sores before so familiar with the symptoms. But haven?t had one in years and had only occur when my immune system is weak from a fever. In the past.  And I have not been sick.
Pretty severe itch; Developed a rash all over his back; Had a sore throat; Had mild COVID-19 symptoms; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Had a sore throat), PRURITUS (Pretty severe itch), COVID-19 (Had mild COVID-19 symptoms) and RASH (Developed a rash all over his back) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concomitant products included IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDE (ADVIL COLD) for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (Had a sore throat) and COVID-19 (Had mild COVID-19 symptoms). On 08-Feb-2021, the patient experienced PRURITUS (Pretty severe itch) and RASH (Developed a rash all over his back). The patient was treated with TRIAMCINOLONE at an unspecified dose and frequency. On 06-Feb-2021, OROPHARYNGEAL PAIN (Had a sore throat) and COVID-19 (Had mild COVID-19 symptoms) had resolved. At the time of the report, PRURITUS (Pretty severe itch) and RASH (Developed a rash all over his back) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Feb-2021, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant- sinus.
08/11/2005 Chills, low grade fever, sore throat, swollen lymph nodes-neck. Still having symptoms today 8/12/05. Taking Tylenol for fever.
Per pt 4 weeks after injection pt developed arm pain - restricted activity - prohibited sleep - ADVIL - MOTRIN and heat - symptoms resolved 2 weeks ago.
Information was received on 20-OCT-2016 from a medical assistant. The Medical assistant reported that a patient received the first two dose of the GARDASIL series with GARDASIL (lot numbers and expiration dates unknown) on unspecified dates. Now the patient was back in the office to receive the third dose in the series with GARDASIL 9 (lot number M023169, expiration date 13-JUN-2018). No adverse effects reported. No additional information provided. It is unclear if the patient received GARDASIL 9. Additional information has been requested.
Patient was administered with vaccine past the BUD (17-Feb-2023); No adverse event; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine past the BUD (17-Feb-2023)) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 065H22A) for COVID-19 prophylaxis.     Patient did not report any medical history or conditions, allergy, concomitant diseases and risk factor (including any previous COVID-19 diagnosis). The patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine past the BUD (17-Feb-2023)) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine past the BUD (17-Feb-2023)) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine past the BUD (17-Feb-2023)).    No concomitant medications were provided. The vaccines were administered between 13-Mar-2023 to 05-Jun-2023. Patients received the vaccine either as the 3rd, 4th or 5th dose. No treatment medication was provided. This case contains information for the 10th of 20 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-727707 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727707:Master case
Lymphadenopathy and lymphatic cording limiting use of the arm and severe pain all the way to the wrist. Pain is constant, limiting sleep, and more severe with raising the arm above the head. Continuous pain three weeks after 1st shot.
Patient admitted for debility, multiple pelvic fractures, and COPD, and was found to be COVID-19 positive.
This spontaneous report was received from a nurse practitioner (N.P.) referring to a 19 year old non pregnant female patient allergic to Sulfa (unspecified). On 02-DEC-1996, the patient was vaccinated with the first dose of VARIVAX (Merck) (Lot#, expiration date, dose and route of administration were not reported). On 21-JAN-2010, the patient was vaccinated with the second dose of VARIVAX (Merck) (Lot #, expiration date, dose and route of administration were not reported). Concomitant medication was not reported. Approximately in 2014, reported as "last year", the patient hurt her shoulder an unspecified way while playing a sport and the patient was "no longer able to play unspecified sports because of that". On 16-NOV-2014, the N.P.  saw the patient in the office and she was diagnosed with shingles (herpes zoster) by unspecified lab work that was performed on an unspecified date. The N.P. stated that she thought the shingles developed in the patient due to the "stress the patient had of not being able to play unspecified sports". The patient was prescribed Acyclovir for the shingles and recovered on an unspecified date. On 02-FEB-2015, the patient went to the office and was diagnosed a second time with shingles, she was prescribed with Acyclovir a "second time" and recovered from the shingles again on an unspecified date. The relatedness between herpes zoster and VARIVAX (Merck) was unknown. Additional information has been requested.