chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient with history of COVID vaccines who admitted to hospital with COVID detected PCR.  Provider d/c note:  "86 year old male with history of hypertension, depression, BPH, CVA who was on hospice, brought in by wife after she found him bleeding 'a lot' from his rectum, states that he passed out twice. She decided to revoke hospice and bring him in. She states that she is alone at home and is sick herself, unable to care for him. Of note patient and wife did test positive for COVID.    GI consulted, planning initially for EGD and colonoscopy. However due to positive COVID test, and patient remaining hemodynamically stable without further evidence of bleed, decision was made to postpone procedures. They recommended waiting for quarantine to finish, as long as he remained stable, and possibly due procedure as outpatient. Diet was advanced and no further signs of GI bleed found   Wife initially asked about placement due to her being sick and home alone. They would need to pay out of pocket due to only having priority medicare. Inquiries made about patient's medicaid status, however wife recovered from COVID and decided her, family, and her pastor/church community could help care for the patient at home. He was discharged in stable condition, family noted they would re-enroll him in hospice and ask for additional assistance at home.   Treated with home medications for chronic conditions including CVA, hypertension, BPH. PT/OT treated him for debility while he was here. Bright red blood per rectum had resolved."
Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 26-AUG-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number J003360, Exp. Date: 21-JUN-2014). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
CHILLS, LOW GRADE FEVER AND BODY ACHES. SYMPTOMS LASTED 8 HOURS AND SUBSIDED RELATIVELY QUICKLY.
Patient took oral typhoid dose 1 06/24/2005, early afternoon dose 2 06/26/2005 12:00pm.  06/27/2005 10AM diarrhea for few hours, vomited about 3 times.  By 06/27/2005 4pm felt recovered.
Fatique, fever and chills, 100 degree temp, physically felt bad but mentally felt well, malaise. 12-36 hours post injection. Treatment was hydration and bed rest.  Migraine (7 on 0 to 10 scale), dry cough, transient hot flashes. 36 to 60 hours post injection. Treatment included Tylenol otc, aspirin otc, flonase otc, caffeinated drinks, bed rest.  Tinnitus, 60 hours and continuing post injection
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 08-MAY-2012, the patient was administered with a dose of VARIVAX (Merck) (Lot # 1909AA expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of 121 reports received from the same source. Additional information has been requested.
Vaccinated and boosted by Pfizer yet I still got COVID; Vaccinated and boosted by Pfizer yet I still got COVID; Vaccinated and boosted by Pfizer yet I still got COVID and have been sick for past 5 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Vaccinated and boosted by Pfizer yet I still got COVID"; ILLNESS (non-serious), outcome "not recovered", described as "Vaccinated and boosted by Pfizer yet I still got COVID and have been sick for past 5 days".  Clinical course: Description of Inquiry: Patient was vaccinated and boosted by Pfizer yet patient still got COVID and had been sick for past 5 days. Doesn't inspire a lot of confidence in efficacy sorry.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender who on 06-MAY-2015 was vaccinated with a dose of GARDASIL lot # K006960 (route and dose were not provided) that was exposed to temperatures outside of the recommended range during an unknown number of hours. No adverse effects had been observed or reported. This is one of several reports from the same reporter.
This spontaneous case was initially received on 29-OCT-2015. The case report was received from a(n) Non Health Professional and concerns a(n) 70 years old female patient. Weight not provided. Height: Not provided. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): the patient received AFLURIA on 28-OCT-2015 - 28-OCT-2015, Batch no: U54205, Route of administration: not provided, Dose: 0.5 ml. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 29-AUG-2015, after starting/treatment with AFLURIA the patient experienced Pain at the injection site that feels like she has been "punched in the arm" in the area where she got the injection (non serious, outcome: Not Recovered/Not Resolved) and cannot sleep due to pain on left side (non serious, outcome): Not Recovered/Not Resolved. Action taken: Drug withdrawn. Event treatment: nothing seems to be helping with pain. Rechallenge/Dechallenge information: not applicable. For relevant test results see appropriate report section. Reporter's assessment: Not provided.
She was super tired, running a low grade temperature, broke out in a rash, and the injection site has started to swell.  We took her to the pediatrician(for an unrelated checkup) who stated the rash could just be from a viral infection and to keep an eye on her.
Numbness in legs became severe. Pain in arms became severe. Muscle and weakness and fatigue pronounced and present throughout day.
Information has been received from a pharmacist concerning a 78 year old female with no drug reactions or allergies who on 04-Mar-2009 was vaccinated SC with a 0.65 ml dose of ZOSTAVAX (Merck) (Lot # 654801/ 0129U). On 04-Mar-2009 the patient developed a "low grade" headache above her eyes. At the time of this report, the patient's symptoms persisted. The patient spoke to the pharmacist and sought unspecified medical attention. Additional information has been requested.
Patient started losing her voice and having to clear her throat. Had history of anaphylaxis reactions to other medications in past. The reaction started happening approximately 5 minutes after vaccine given. Patient was given Benadryl 50mg IM in R arm. Vital signs were taken and noted to be stable except high blood pressure. Vital signs taken again after 5 minutes and remained stable with only slight decrease in BP. After approximately 10minutes patient had stopped clearing throat and her voice had returned and she was back to her baseline health. Was told to go to Emergency Room for elevated BP.
After second dose on 2/1/2021 at 6 PM, symptoms started at 2:30 AM and ended at 9 PM on 02/02/2021. I had chills, muscle aches, a fever, extreme tiredness, and a slight headache.
Received shot 0710A - at 845Am became flushed, dizzy, strange feeling in head, lightheaded and had metallic taste in mouth. Became shaky. Symptoms lasted 30 min - subsided slowly over next 2 hours.
Soreness after 2nd dose where vaccine was administered; Dizziness; Dizziness worst with 2nd dose; Chills; Fever of 100 F; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE JOINT PAIN (Soreness after 2nd dose where vaccine was administered), DIZZINESS (Dizziness), DIZZINESS (Dizziness worst with 2nd dose), CHILLS (Chills) and PYREXIA (Fever of 100 F) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included Vertigo. Concomitant products included CLONAZEPAM, PRAVASTATIN, IRBESARTAN and PANTOPRAZOLE for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE JOINT PAIN (Soreness after 2nd dose where vaccine was administered), DIZZINESS (Dizziness), DIZZINESS (Dizziness worst with 2nd dose), CHILLS (Chills) and PYREXIA (Fever of 100 F). The patient was treated with MECLIZINE HCL at a dose of 25 milligram. At the time of the report, VACCINATION SITE JOINT PAIN (Soreness after 2nd dose where vaccine was administered), DIZZINESS (Dizziness), DIZZINESS (Dizziness worst with 2nd dose), CHILLS (Chills) and PYREXIA (Fever of 100 F) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-109845 (Patient Link).
I had the shot as stated above.  I was ok until about 1am(29Oct22) WHEN I WOKE UP WITH CHILLS AND MUSCLE ACHES.  I WENT BACK TO SLEEP AND WOKE UP ABOUT 730AM.  I GOT UP WENT TO THE KITCHEN TO PREPARE COFFEE WHEN I FELT VERY DIZZY AND BLACKED OUT AND FELL TO FLOOR.  MY WIFE HEARD THE FALL AND CAME TO THE KITCHEN AND I WAS ON THE FLOOR BUT WAS THEN CONSCIOUS.  SHE ASKED IF I WANTED HER TO CALL EMS AND I SAID NO.  SHE WIPED ME DOWN BECAUSE I WAS SWEATING, SHE GAVE ME SOMETHING TO DRINK.  AFTER A FEW MINUTES I SLOWLY GOT TO MY FEET, HAD MORE WATER AND MY WIFE ASKED AGAIN IF I WANTED HER TO CALL EMS, I SAID NO.  I STILL DIZZY, CHILLED AND ACHEY BUT I DID NOT HAVE DIFFICULTY BREATHING AND HAD NO CHEST PAIN.  SHE HELPED ME
Right upper thigh with erythema, induration and warmth within 24 hours of vaccine.
Patient is a 21 yr old hispanic female was given the Gardasil vaccine on Right arm on Friday Nov 30, 2007 at 2:30 p.m. She reports mild fever was given Two Advils P.O. On Sat Dec 1, 2007, she reports mild headache and mild coughing no meds taken at this point. On Sunday Dec 2, 2007 she reports mild ongoing coughing with mild rash on body she reports no meds taken. On Monday Dec 3, 2007 she reports swollen hands with lid edema on right leg and a moderate rash on body. At this point she took Benadryl 2 tablets P.O. every 4 hours, with plenty of liquids.
Patient says her shoulder and arm have been sore since the immunization (about three months ago).  Patient says the pain also sometimes radiates down her arm. She mentioned that the pain is most painful at night. Patient has not gone to see the doctor.
losing a lot of weight; couldn't eat; nauseated; only received one dose/over six months ago and did not go back for her second dose,did not receive 2nd dose in the series; left arm was red; circle on her left arm bigger than a silver dollar; injection arm swelled up so big it looked like a big pimple; felt sick for 18 days after first dose,really sick for 18 days; covid arm; sluggish; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (felt sick for 18 days after first dose,really sick for 18 days), VACCINATION SITE REACTION (covid arm), SLUGGISHNESS (sluggish), WEIGHT DECREASED (losing a lot of weight) and EATING DISORDER (couldn't eat) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Post-traumatic stress disorder and Anxiety. Concurrent medical conditions included Allergy to antibiotic (erythromycin) and Allergy to antibiotic (citalopram). Concomitant products included PIROXICAM (PAXIL [PIROXICAM]) for an unknown indication.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 31-Jan-2021, the patient experienced ILLNESS (felt sick for 18 days after first dose,really sick for 18 days), VACCINATION SITE REACTION (covid arm), SLUGGISHNESS (sluggish) and VACCINATION SITE SWELLING (injection arm swelled up so big it looked like a big pimple). On 12-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (left arm was red) and VACCINATION SITE INDURATION (circle on her left arm bigger than a silver dollar). On an unknown date, the patient experienced WEIGHT DECREASED (losing a lot of weight), EATING DISORDER (couldn't eat), NAUSEA (nauseated) and INTENTIONAL DOSE OMISSION (only received one dose/over six months ago and did not go back for her second dose,did not receive 2nd dose in the series). At the time of the report, ILLNESS (felt sick for 18 days after first dose,really sick for 18 days), SLUGGISHNESS (sluggish), WEIGHT DECREASED (losing a lot of weight), EATING DISORDER (couldn't eat) and NAUSEA (nauseated) outcome was unknown and VACCINATION SITE REACTION (covid arm), VACCINATION SITE ERYTHEMA (left arm was red), VACCINATION SITE INDURATION (circle on her left arm bigger than a silver dollar), VACCINATION SITE SWELLING (injection arm swelled up so big it looked like a big pimple) and INTENTIONAL DOSE OMISSION (only received one dose/over six months ago and did not go back for her second dose,did not receive 2nd dose in the series) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were provided. Patient went to see her primary care physician and was told she had "COVID Arm".   Most recent FOLLOW-UP information incorporated above includes: On 13-Oct-2021: Added medical history, allergies,  updated product dosage and route of administration, concomitant medications, new events added.
No adverse event; vaccines administered past the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccines administered past the expiration date) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccines administered past the expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccines administered past the expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (vaccines administered past the expiration date).    Concomitant medication was not reported. As per the provider the vaccines were stored in a standard freezer (15°C to -25°C). Their temperatures were Max: -24°C and Min: -23°C. vaccines were received on 27-Dec-2020. Treatment medication was not reported.  This case contains information for the 9th of 13 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-728240 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2023: Non-significant follow up.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-728240:Master Case(Patient 1)
This spontaneous report was received from a nurse referring to a 12-month-old patient. Concomitant therapy included PREVNAR 13. Information about medical history and concurrent conditions were not provided. On 19-FEB-2019, the patient was vaccinated with 2 doses of VARIVAX (strength, dose detail, route, lot # and expiration date were not reported) and 2 doses of VAQTA (strength, dose detail, route, lot # and expiration date were not reported) for prophylaxis (incorrect dose administered). No adverse symptoms reported.
LARGE (2 INCH DIAMETER) RAISED SWOLLEN KNOT, EXTREME ITCHING/BURNING, RED PATCH. TREATMENT WITH ICE PACKS SEVERAL TIMES. THREE DAYS OUT, STILL USING ICE, CONDITION IS RESOLVING.
Swelling, tenderness at infection site. Muscle aches, nausea, chills, sleepiness, headaches.
fever; This is a spontaneous report from a Pfizer-sponsored program. A contactable male consumer (patient) reported for himself that a male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on 29Mar2021 as single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. He got the first dose of the Pfizer covid vaccine on March 29th and he has fever. He said that all of the other symptoms have disappeared but the fever remains and he wanted to know if they can take acetaminophen. The outcome of event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
female patient was accidentally given 2 doses of Arexvy on 04Oct2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of overdose in a female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 7942H, expiry date 02-MAR-2025) for prophylaxis.   Concomitant products included RSV VACCINE PROT. SUBUNIT PREF3 (AREXVY).   On 04-OCT-2023, the patient received Arexvy. On 04-OCT-2023, an unknown time after receiving Arexvy, the patient experienced overdose (Verbatim: female patient was accidentally given 2 doses of Arexvy on 04Oct2023).  The outcome of the overdose was unknown.   Additional Information: GSK receipt date: 4-Oct-2023 The pharmacist reported no symptoms. The reporter declined to provide patient's date of birth. The reporter consented to follow-up via email. The patient was accidentally given 2 doses of Arexvy on the day of reporting, which led to overdose.
Client called on 9/12/19. C/o fatigue, increase temp (100.3), starting on 9/11/19 and going into 9/12/19. She also had no appetite and was "out of it" at times. The swelling of a half dollar coin started on left arm at the injection site growing into a little larger in size and painful to touch. No rash.I explained to her that this is normal per VIS sheet. I instructed her to put a cool compress on it and to take Tylenol or Motrin to help with discomfort. 9/13/19 Called client today. She said that she still has fatigue, but the red spot (injection site) is less red and she can move her arm better. She also said she had some diarrhea during the night, but its probably not from the shot. She is feeling better.
Pt. stated "whole arm" hurt from injection site down to hand and up to around back of neck. States she could not pick up her purse or her groceries. No reported skin redness, itching, or swelling.
Patient reports about 12 hours after receiving PREVNAR vaccine she had local reaction. The area of the shot swelled up to the size of an apple, it was red and warm to the touch. She took a BENADRYL and placed cool compresses on her arm. The area is now pink and only swollen to the size of a walnut.
Headache, chills, body aches, fever (maxed at 101-degrees Fahrenheit on the second day) lasting 3 days.  Lymph nodes very swollen and painful under left arm, lasting 5 days.
Tested positive for Covid virus, after being fully vaccinated event; covid positive; This is a spontaneous report from Pfizer a contactable pharmacist, the patient.  A 34-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was not provided), via an unspecified route of administration, administered in the left arm on Friday 05Feb2021(at the age of 34 years) as dose 1, single, for COVID-19 immunization, by a technician. Reason for not providing lot number was mentioned as patient was unwilling to complete the report. The patient's medical history and concomitant medications were not reported. On 05Feb2021, they injected the vaccine pretty low about 4.5-5 inches from the top of her shoulder (injected low in the arm and not in the muscle) and she believed that the vaccine was administered incorrectly, because it was not administered in the deltoid muscle (Vaccine administered at inappropriate site). She stated that, on unspecified date in 2021, her arm was pretty sore to lay on and the fatty tissue was sore, and she experienced pain at the injection site but did not experience any muscle soreness in her triceps or deltoid muscle. She states they are monitoring and tracking the vaccine breakthrough cases in their area and she had some concerns regarding one specific lot number that 15% of their breakthrough cases had received. The caller at the time, did not have the NDC or expiration date, however, was going to work on pulling patient information so that she would be able to have this information available to provide upon transfer. Agent states the Caller was an assistant director of health and works at a local health department. Agent states the Caller called because she had some concerns, and the health department is tracking breakthrough cases in her area. Agent reports that Caller states 15% of breakthrough cases are from one Pfizer Covid 19 Lot number: EN5318. Agent confirms Caller is calling about the Pfizer Covid 19 vaccine. Caller confirms she was calling about the Pfizer Covid 19 vaccine. Caller reclarifies later in report that 15% of the breakthrough cases in her county had the same lot number, EN5318, which was concerning. Caller states, reclarified later in report, she had 37 patients with partial identifiers. Caller states she cannot provide some identifying details and that she would need to check with her legal department first. Caller states that Covid positive was defined as having both vaccines and testing positive for Covid longer than two weeks after both doses. Testing positive for Covid virus, after both vaccines. Patient was hospitalized with Covid, but no other information can be provided by Caller. The outcome for the events was unknown at the time of report.  Follow-up attempts completed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101075254 Same reporter/ drug/ event for different patients
Moderna Bivalent vaccine was administered at 11 am, At 12:20 pm the patient developed abdominal pain, vomiting, diffuse flushing involving arms/legs/trunk/face, and hives. He was given Benadryl at 3:45 pm but flushing of skin worsened. He presented to the Emergency Department at 7:30 pm. Findings notable for diffuse flushing and abdominal tenderness to palpation diffusely. Vitals were normal. He did not have angioedema, hives, or wheezing,
Period is a week late. It?s never irregular. I was perfectly healthy before this. There is no reason for my period to be late.
Kind of allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Kind of allergic reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergic reaction.    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 HYPERSENSITIVITY (Kind of allergic reaction). At the time of the report, HYPERSENSITIVITY (Kind of allergic reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.