chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse regarding an unknown age and gender patient. On 03-MAR-2012 at 11:30am, ZOSTAVAX, lot # 672477/1604AA was exposed to -12 C for an estimated total time out of range of 4 hours. On 17-APR-2012 at 7:30am, ZOSTAVAX, lot # 672477/1604AA was exposed to -12 C for an estimated total time out of range of 14 hours. On 22-MAY-2012, the patient was administered an out of range dose of ZOSTAVAX, lot# 672477/1604AA expiration date: 13-JAN-2013 (dose and route were not reported). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Information has been received from a registered nurse who in 1996 was vaccinated with a dose of Varivax. Recently, a titer was negative. She was not recovered. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Approximatively 6-8 hours after receiving 2nd dose, patient began to experience low grade temp, general malaise, severe myalgia, and chills, and restlessness.  This lasted over night. The next day patient returned to baseline.
According to Dr the signs/symptoms started with twitching of left arm and diaphragm. Seen at hospital and transferred to Clinic. Had chest wall and upper extremity myoclonia no fever, no warms, no change in mental states. No upper respiratory changes no nausea or vomiting. No rash. Duration of symptoms 3 hours and nothing after that. No new terms from Discharge Summary rec'd/12/05/2005
This study case was received from the investigator in a trial on 30 January 2014. A female subject (date of birth not reported) had received the following vaccines on 23 January 2014: ACAM2000 (lot number, route and site of administration not reported), ANTHRAX (manufacturer, lot number, route and site of administration not reported) and TYPHOID (manufacturer, lot number, route and site of administration not reported) and five days later, experienced a 20 minute episode of chest pain during exercise which resolved spontaneously without any treatment. Rapid Troponin was negative and on 30 January 2014 a preliminary ECG was slightly abnormal with minimally shortened PR interval. The subject was referred appropriately. No further information was available at the time of the report. The subject's outcome was recovered on 28 January 2014. According to the investigator, the event of chest pain was considered mild, an "other important event" and possibly related to vaccination. Documents held by sender: none.
Serious nausea  Dry heaving for 24 + hours Splitting headache Nose bleed  All of this caused severe dehydration. Symptoms started Saturday morning. Doctor had to prescribe Zofran. They did give me the option to go to the ER which I didn?t take. Started the meds on Sunday around 8pm. On Monday morning had to take another dose. After 2 doses and sipping Gatorade the worst of the symptoms receded by 1pm Tuesday but still fatigued 5 days later.
Vaccine administered at 0800. 5-10 minutes later, patient reported tightness in throat and shortness of breath. Patient became dizzy, nauseous, diaphoretic, reclined back and elevated feet. Patient was taken to emergency department for further treatment.
soreness of arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness of arm) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-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 arm). At the time of the report, PAIN IN EXTREMITY (soreness of arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medications were not provided by reporter.  Treatment information was not provided by reporter.   This case was linked to MOD-2021-331145, MOD-2021-331146 (E2B Linked Report).; Sender's Comments:  MOD-2021-331146:Dose 3 case MOD-2021-331145:Dose 2 case
2 family's members of hers died after receiving the Pfizer BioNtech covid 19 vaccine; One person who already had heart damage the vaccine exacerbated it and the spike proteins in their heart.; One person who already had heart damage the vaccine exacerbated it and the spike proteins in their heart.; This is a spontaneous report from a Non-contactable consumer. This consumer reported for 2 other patients that a patient of unspecified age and gender received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. Medical history included cardiac disorder from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced 2 family's members of hers died after receiving the pfizer biontech covid 19 vaccine on an unspecified date , one person who already had heart damage the vaccine exacerbated it and the spike proteins in their heart on an unspecified date with outcome of unknown. The patient died on an unspecified date. It was not reported if an autopsy was performed. The clinical course was reported as follows: Caller stated common knowledge that your vaccine and moderna create spike protein within the body, how do you as a company plan to fix that? It doesn't stay in the arm, the spike protein is whats causing the excess problems. Caller reported 2 family's members of hers died after receiving the Pfizer BioNtech covid 19 vaccine. One person who already had heart damage the vaccine exacerbated it and the spike proteins in their heart. She also reports various adverse events...damage to the heart , Guillen barre, women miscarrying their babies, other women starting periods after menopause. Caller stated that creator of the mRNA stated that its going to kill people within 3 years. Caller also states that white coat summit states its dangerous and unsafe. How you plan on helping theses people who have financial responsibility who can no longer work, care for their families, no longer here for their families or the Comirnaty vaccine damaged them unrecognizably. Caller states that the Comirnaty vaccine is not preventing or saving anybody from the covid 19 infection.  No follow-up attempts are possible; information about lot/batch number cannot be obtained; Reported Cause(s) of Death: 2 family's members of hers died after receiving the Pfizer BioNtech covid 19 vaccine
Patient received the vaccine on 2/8/21.  There was a continued gradual weight loss and decrease of appetite after vaccine.   On  3/2, patient had unknown reason for elevated blood sugar of 303.  On 3/4, patient had oxygen of 78% on room air, Pulse 127, RR 22, BS 158. Oxygen started. Lethargic, hypoxic, tachycardia.  Transfer to hospital.  Patient readmitted on 3/12/21 with community acquired pneumonia, bacteria in urine  acute kidney injury.  Treated with antibiotics and hydration.
PATIENT VOMITED A SMALL AMOUNT OF CLEAR LIQUID AFTER BEING VACCINATED. DENIED DIZZINESS OR HEADACHE.
Got the shot on Friday, 10/9. Woke up Monday morning with laryngitis, tightness in chest, shortness of breath, pressure in sinuses. During the week I got worse. Second week I could not speak at all, went to my doctor, who told me I had reaction to flu shot. Singular and Albuterol did nothing. Monday I went to Urgent care to get prednisone. Wednesday back to Urgent care to get Z-Pak. Extreme amount of phlem in my lungs. Today is 11/2 and I am still suffering. I haven't been able to work for 2 weeks and this is starting the 3rd week. If I cannot talk, I cannot work. Right now I'm trying to find out what exactly happened to me. I have never reacted to a vaccine.
ADMISSION: 12292021: 57-year-old male with a history of stage IV colon cancer status post resection in 2013, liver cancer who presented to the emergency department with shortness of breath, cough, dizziness and weakness for the last 2 days.  He reports also having a low-grade fever along with this.  He has had some nausea and abdominal discomfort and diarrhea but this is actually been going on for several months now.  Does report some intermittent bloody stools and melena as well.  He reports he has not really been followed for his colon cancer as at 1 point he was on hospice for 2 years and then came off of hospice and has not really followed since that time.  He is vaccinated and received his booster on 12/15/2021 He lives at the facility and has exposures there.   Workup in the emergency department reveals relatively normal CBC and BMP.  His COVID swab is positive.  His ABG shows hypoxia and he has required 2 L of supplemental oxygen as well.  Chest x-ray does show some areas of bilateral airspace disease.  CT abdomen pelvis shows possible esophagitis along with postoperative findings and some fluid-filled bowel loops suggesting possible enteritis.  Given his hypoxia he has been admitted.  PATIENT IS CURRENTLY AN INPATIENT.
Shingles; This spontaneous report was received from a physician via pfizer refers to a 66 year old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date in 2013(reported as 6years ago) the patient was vaccinated with zoster vaccine live(ZOSTAVAX)(lot#, expiry date was unknown) for prophylaxis. On an unknown date, the patient experienced shingles. The outcome of the event was unknown. The causality was not reported.
Expired Product Used; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 51-year-old female patient who received HAV (Havrix) (batch number 299X2, expiry date 24th January 2022) for prophylaxis.   On 17th March 2022, the patient received the 2nd dose of Havrix. On 17th March 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 31-MAR-2022 Reporter's comment: The nurse reported that, the patient received an expired dose of the Havrix in left deltoid and wanted to know what to do next. The reporter consented to follow up. Additional Supportive Information: The patient received a dose of Havrix and it was already expired on 24th January 2022, which led to expired vaccine used.
This was the 2nd dose in the series for an underage minor. This was an "off label" use to finish the vaccine series. According to the CDC it was recommended that this minor finish the series of Moderna.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Additional Details: Immunization verified under (name), (name) administered, patient fainted during the 15 minute monitoring session. Patient was over-heated, fainited, responded immediately, had to prop patient up, continued to talk verbally to keep patient engaged. gave a cold water to rest behind neck, patient was sweaty, dizzy, propped a fan to cool patient, helped immediately, color returned to patient face. spoke with patient and mother of patient. counseled pt to be picked up. wfu with pt tomorrow.
feels weak; very bad chills; headachy; achy; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (feels weak), CHILLS (very bad chills), HEADACHE (headachy) and MYALGIA (achy) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cancer.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ASTHENIA (feels weak), CHILLS (very bad chills), HEADACHE (headachy) and MYALGIA (achy). At the time of the report, ASTHENIA (feels weak), CHILLS (very bad chills), HEADACHE (headachy) and MYALGIA (achy) outcome was unknown.            No concomitant medications reported. No treatment information was provided.
Multiple hives on chest, back, face, swelling of ears.  1 hour after immunization. Improved with Benadryl.
itchy injection site; redness; inflammed, like little balls around it; dizzy; weakness; headache; chills; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), ASTHENIA (weakness), VACCINATION SITE PRURITUS (itchy injection site), HEADACHE (headache) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced DIZZINESS (dizzy), ASTHENIA (weakness), HEADACHE (headache), CHILLS (chills) and FATIGUE (fatigue). On 18-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itchy injection site), VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE RASH (inflammed, like little balls around it). At the time of the report, DIZZINESS (dizzy), ASTHENIA (weakness), VACCINATION SITE PRURITUS (itchy injection site), HEADACHE (headache), CHILLS (chills), FATIGUE (fatigue), VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE RASH (inflammed, like little balls around it) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  No treatment details were provided.
passed the recommended dosing interval; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (passed the recommended dosing interval) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In February 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 PRODUCT DOSE OMISSION ISSUE (passed the recommended dosing interval). At the time of the report, PRODUCT DOSE OMISSION ISSUE (passed the recommended dosing interval) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Treatment information was unknown.
C/O URTICARIA, FLUSHING,AND PRURITIS AFTER RECEIVING  P-4 DAY VACCINES. OVER ENTIRE BODY, lung clear CTA. Rev'd Benadryl and Epi.
Patient developed shingles 6 days after immunization. She is being treated with acyclovir for the shingles.
Influenza Virus Vaccine (FLUVRIN) 2008-2009 Formula Expiration Date 6/30/2009 Given Instead of 2009-2010 Formula, Vaccinated with Influenza Virus Vaccine (FLUZONE) 2009-2010 Formula After Error Discovered.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Additional Details: 13 year old female fainted when sitting during her 15 minute observation. she fainted when her mom was standing next to her. we put her on the floor and raised both of her feet. she became concious after 15 seconds. We gave her water and chocolate. we took her blood pressure and her reading was 95/71 with pulse of 78. we had her sit for an addiotional 15 minutes. After feeling ok she left with her parents.
14 hours after injection I started experiencing chills and body aches...eventually around 16 hours after injection became really warm, fever reached 101.3. Fatigue. Could barely stand and experienced some shortness of breath/headache. Slept for 2.5 over night. Attempted to work the next morning, but left after a couple of hours. Experienced more chills and a fever of 100.3 approximately 30 hours after injection. Fatigue/aches continued. One more round of chills/warm body with high temp of 99.8 degrees @ 36 hours after injection. Took ibuprofen throughout. Melatonin 5 mg and went to sleep for the night. Woke up feeling great!
Developed shoulder pain and decreased ROM within 24 hours of vaccination.  Pain persists through date of report.
she felt just a little tired; she had pain in her left hand; This is a spontaneous report from a contactable consumer.   This 45-Year-Old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection)  from Lot# E81284 at single dose for covid-19 immunization.Medical history included blood pressure and birth control .Concomitant medication included lisinopril (LISINOPRIL) for blood pressure, ethinylestradiol, ferrous fumarate, norethisterone acetate (JUNEL FE) for birth control, pantoprazole (PANTOPRAZOLE).After the first dose , she felt nothing, just a little tired and she had pain in her left hand. Outcome of the events was unknown.
Tdap 4/23 soreness that evening. 4/24-redness at site and below Band-Aid. 4/26-redness-large area-big as hand (hand covered area) warm and hot touch. Chills 4/24 and 4/25; diarrhea 4/24, 4/25 and 4/26. Evaluated-tx ALLEGRA or CLARITIN; warm compresses 3rd day. Return if not improved.
Pt came in to get 2nd hep b, looking at his record I saw he was given a PROQUAD injection. I called Merck and reported it, Dr spoke with the pt and it was reported on this as well.
Fever developed 102 degrees 10/18/02 evening. Seen in office 10/19/02 pm 6cm area of swelling with 4cm erythema L upper thigh. Admitted to hospital 10/20/02 for cellulitis-received IV mx, then po Keflex. F/U appt. 10/25/02 in office, resolving sx, afebrile.
Pain, pain, pain, and blisters, itchy and  soreness. I went to the Clinic ER because I was in so much pain in my chest and back and they kept me over night and ran test. I was sent home and returned in a couple of days cause I was still in pain and was diagnosed with Shingles.
Pt received IPV, DTaP, MMR in 08/21/2002 developed bad rash, Mom thought it was the measles. No treatment or OV at time , Seen 09/09/02 to WCE c/o rash going away but caused hand/feet to peel. Per acknowlegment letter, all vaccine information was unknown. They wer given at a different location.
Pt devel urticaria and failed to seroconvert after hepta B vax.
loss of visual acuity in right eye.  Eye exam with distance correction had 20/20 vision on August 15, 2022.  Loss of visual acuity to 20/40 with correction in right eye on date noted above.  am currently using eye drops and will follow up with retinal and corneal specialist.  was seen in emergency room and then eye clinic.  changes were seen in mapping of right cornea
After COVID19 Booster 9/15/21 developed "severe" Herpes Zoster 10/2/21 Left Rib Cage, circumferential around entire Left Ribs, 4inch x 20inches. As of 10/26/2021- still great pain and itch/distress
18 days after the first vaccine, I started having covid 19 symptoms (headache, fatigue, uncomfortableness). I was diagnosed with COVID 19 in October of 2020 so this was similar
I have a lot of muscle pain in my left arm and my shoulder blade, I can't sleep very well because of the pain, I have taken ibuprofen few times but it calms me down for a few hours, yes I can lift my arm and move it but I feel pain and discomfort all the time.
Information has been received from a physician via company representative referring to a patient of unknown age. On an unknown date the patient was vaccinated with M-M-R II (dose, route and frequency were not reported, lot# was unknown) and VARIVAX (Merck) (dose, route and frequency were not reported, lot# was unknown) at the same time. The reporter reported after receiving the vaccines, the patient experienced urticaria. The outcome of urticaria was unknown. Additional information has been requested.
This spontaneous prospective pregnancy report was received from a Nurse practitioner refers to a 22 year old female patient. On 04-MAR-2014, the patient was vaccinated with first dose of GARDASIL lot # H021346 (Expiry: 01-OCT-2015) 0.5 ml, intramuscular. The LMP was reported as 05-FEB-2014. The EDD was estimated as 12-NOV-2014. On 11-MAR-2014, the patient was seen in the office and had a pregnancy test. The pregnancy test result read positive. No further information was provided. Additional information has been requested.
I RECEIVED SHOT AT APPROX.  8:00AM, FRIDAY, JUNE 28, 2019, IN THE LEFT UPPER SHOULDER/ARM AREA AT THE STATION OF DR., AT THE CLINIC.  I HAD NO IMMEDIATE REACTION, BUT BY 1;00PM MY LEFT SHOULDER NSTARTED TO FEEL VERY TIGHT.  I TRIED STRETCHING IT. BY 3:00PM I STARTED GETTING WORSE AND WORSE ACHE IN LEFT SHOULDER AREA. IT GOT TO THE POINT THAT I COULD NOT RAISE MY ARM WITHOUT SEVERE3 PAIN. I WENT HOME AND TOOK TYLENOL , 2 PILLS AND WENT TO BED.  ALSO USED ICE PACK ON SHOULDER.  THE PAIN SUBSIDED A LITTLE, BUT RETURNED AS SOON AS TYLENOL WORE OFF.  TOOK 2 MORE TYLENOL AGAIN HELPED A LITTLE BUT STILL SEVERE PAIN WITH ANY MOVEMENT. NEXT DAY WAS NAUSEATED.. THE SHOULDER WAS SOMEWHAT BETTER AND BY THE  30TH IT WAS CONSIDERABLY BETTER.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 62 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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 included: "Shellfish allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Received paxlovid treatment 03May2023 to 07May2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300192795 Same patient, different drug and different event;
Pt received injection at 8:45am on 4/2/03, did not mention any rxn to MD when seen at 10:50am, pt went to another medical facility on 4/3/03, complaining of rxn to injection site, redness, swelling, and pain at site.
Patient is 67-year-old female that presents the emergency department with abdominal pain nausea vomiting diarrhea.  Patient history was obtained through patient interview and chart review.  Patient states that her symptoms started approximately 4 days ago and progressively worsened.  Patient did receive the second dose of the Pfizer vaccine 5 days ago.  Patient describes the pain as left-sided upper abdominal pain that is worse with activity denies any other aggravating factors.
This spontaneous report was received from a pharmacist referring to multiple unspecified patients of unknown age and gender. The patients medical histories and concurrent conditions were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot # L014876, expiration date 13-JAN-2017; lot # L021367, expiration date 05-NOV-2016) (dose and route of administration were not reported). No adverse effect reported. There was no product quality involved. This is one of two reports from the same reporter (1512USA013616). Additional information has been requested.
Right arm began to feel like it was asleep. It never stopped tingling. Became very weak. I couldn't write my name. Right hand was dominant hand until this happened.