chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Glucose level, mostly high; Suspected vaccination failure/second dose MAR-2019, shingles in July 2021; shingles, 4 outbreaks; second dose MAR-2019, shingles in July 2021; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included diabetes (was diabetic since 2017 and on medication to control them).   In March 2019, the patient received the 2nd dose of Shingrix. In July 2018, the patient received the 1st dose of Shingrix. In March 2019, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. In July 2021, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced glucose increased. The patient was treated with valaciclovir (Valacyclovir). On an unknown date, the outcome of the vaccination failure, shingles, glucose increased and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and glucose increased to be related to Shingrix and Shingrix.     Additional Information: GSK receipt date: 9-Oct-2022 and 11-Oct-2022 Reporter's comment: The patient was currently 68 years old. The patient had a pharma background and had detailed his/her medical history. The patient wanted to talk to clinician about Shingrix vaccination. The patient received both doses Shingrix vaccine and the approximately 8 to 9 months between doses. The patient contracted a mild case of shingles and apparently joined the 10 percent club as Shringrix was advertised as 90 percent effective.  The patient was treated with Valacyclovir. The patient reported that however over the next 14 months, he/she had 3 additional outbreaks of shingles for a total of 4. During the period of outbreak the patient's glucose level were all over the map mostly high. The patient really would like to talk to an expert on Shingrix to get their perspective from any clinical data that was available. The reporter consented to follow-up. Additional supportive information: The patient received the second dose of Shingrix later than the recommended interval, which led to lengthening of vaccine schedule. This case was considered as suspected vaccination failure since the details regarding the laboratory confirmation of shingles were unknown at the time of reporting. The case was linked with case US2022AMR145825, reported by same reporter for different patients.; Sender's Comments:  US-GSK-US2022AMR145825:Same reporter
pt recvd single dose of flu vax as a prophylaxis 17oct94; pt died 21oct94; cause of death unk; pt was receiving many oth meds;
admitted on February 11th with worsening jaundice. I did notice that there is a new onset symptoms date for patient of 2/12.
About 2 weeks after the first vaccine I started noticing hives on my L arm. These hives eventually turned into wheals and were extremely itchy.   The wheals would then turn darker red and eventually disappear.   The next location of the wheal was my R arm, followed by my R calf and then L calf.   As of right now I have a rash on my L foot and L side of my face.   I have never experienced rashes like this in the past.
Case number PHEH2014US005388, is an initial spontaneous report received from a health care professional on 14 Mar 2014. This report refers to an unknown age and gender patient. The patient received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: not reported), intramuscularly without being reconstituted with Men A lyophilized conjugate vaccine component on an unknown date (six or months ago). No adverse event was reported following this administration error.
This spontaneous report as received from a certified medical assistant refers to a male patient (age not reported) who on 07-MAY-2013 received the second dose of GARDASIL (indication not reported) (Lot # H021346, exp. 01-OCT_2015). It was reported that on 15-JUN-2012, the patient received the first dose of GARDASIL. The patient did not experience any adverse effects. Additional information has been requested.
This spontaneous report was received from nurse and refers to an unspecified adult patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On 29-MAR-2017, the patient was vaccinated with an expired dose of M-M-R II (dose, route, and anatomical location were not reported) (lot # L009545 and expiration date 19-MAR-2017) for prophylaxis. It was reported that the vaccine was properly stored. No adverse effects were reported. Additional information is not expected because the reporter refused additional contact.
UPON ADMINISTRATION OF THE VACCINE, THE PATIENT FELT FAINT.  THE PATIENT STARTED SWEATING PERFUSELY FROM HEAD TO TOE.  THE PATIENT LOST CONSCIOUSNESS MULTIPLE TIMES FOR A BRIEF PERIOD OF TIME.  PATIENT WAS NAUSEATED AND ATTEMTED TO VOMIT BUT COULD NOT.  EMS WAS CALLED AND CAME TO ASSIST.  THE CARE OF THE PATIENT WAS THEN TURNED OVER TO THE EMERGENCY MEDICAL SERVICES .   BY THE TIME EMS ARRIVED, THE PATIENT STATED THAT HE WAS FEELING MUCH BETTER. EMS EVALUATED THE PATIENT AND AFTER APPROXIMATELY 15 TO 20 MINUTES THE PATIENT WAS ABLE TO LEAVE ON HIS OWN WITH ASSISTANCE FROM HIS WIFE.
I received the 1st dose of the Pfizer Covid-19 Vaccine on 9/27/2021 mid-day. In the evening I started feeling numbing, slight sharp pains that started spreading from my left shoulder, all the way down the left arm and down my left leg. Pulsating sharp-tingly feelings. Two days later on 9/29/2021 I started feeling chest pains and shortness of breath. Over the course of the next two and a half weeks my symptoms got more severe and had severe pain throughout the left side of my chest, shoulder, and upper back pains (because of pericarditis and bilateral pleural effusion). I was hospitalized and went to the ER on 10/18/2021 at a local hospital. They ran X-ray, Echo, EKG, CT Scan, blood tests, ultrasound. I was transferred to another Hospital that night. I had a thoracentesis on October 19, 2021 and pulled out 800cc of fluid from my left lung which was in response to pericarditis. After all of the tests the cardiologists determined that I had a large pleural effusion and pericardial effusion, which are consistent with pericarditis and pleuritis. On 10/21/2021 I had a follow-up visit with a cardiologist at a Hospital. I was informed that the symptoms described in this paragraph was due to a severe reaction to the Pfizer vaccine received on 9/27/2021.
First dose-sick for three days with diarrhea(8-9 trips to bathroom), body aches, fever (101.7).  Second dose- still sick with fever, body aches and diarrhea
8 days after injection I developed left head tingling/tenderness in left scalp, left external ear, left neck. Yesterday, my left jaw hurt, as well, as did my internal ear. I was talking to my M.D. about an unrelated issue, yesterday,  mentioned what I was experiencing, and he wanted me to report it to the CDC site. I still have it and I am taking Ibuprofen twice a day now with relief. I have no swelling, redness, vesicles, just tenderness, as I would imagine a neuralgia symptom.
Severe tinnitus. There is no treatment and it has not gotten any better since I received the second shot in April.
Headache, Myalgia, Arthralgia, Fatigue and flu like symptoms Narrative:   Other Relevant History:
pt devel swelling @ inj site to Tetramune which lasted 3 days;
Immediate reaction-thick tongue,warmness. Within 20 minutes, rash on face, neck, chest, and arm. Also, elevated heart rate and blood pressure. Given Benedryl and monitored for an hour and 20 minute. Later that same day, had abdominal pain. Pain increase. One 03/02/2021 went to ER. Cat Scan performed. Nothing found.   Continued having problem Went to a gasterointerogist and urologist. Did Endoscropy and Ultrasound. Found mass.   Recently ordered a 2nd Cat scan. 2nd cat scan reveal no mass.   Most recent ER visit was 09/27/2021. Intense pain in abdominal  area on side with nausea and vomitting.
Patient developed redness warmth and swelling at inject site in the evening. Also had chills. Called office 12/11/2018 and was brought in for evaluation. Advised to use warm compresses, OTC pain relief and was put on KEFLEX.
pneumonia; multiple outbreaks of herpes zoster; Information has been received from a lawyer regarding a case in litigation, via Individual Short Form Complaint, regarding a 63-year old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On or about 11-MAR-2013, the patient was vaccinated with a dose of Zoster Vaccine Live (ZOSTAVAX), (route, lot #, and expiration date were not provided) for prophylaxis, at a medical provider. Subsequently, on an unspecified date, the patient was treated by a provider for the following injuries resulting from the vaccination: multiple outbreaks of herpes zoster and pneumonia. At the time of the report, the patient's outcome was unknown. The reporter considered the events to be related to Zoster Vaccine Live (ZOSTAVAX).  Upon internal review, the event of pneumonia was considered medically significant.
Moderna COVID 19 Vaccine EUA  I felt malaise and pain at site of injection within six hours of receiving the second dose of the Moderna vaccine. I was asleep by 9PM and woke around 11 PM with intense nausea. I proceed to vomit violently throughout the night, at least fifteen times. I believe this was intractable nausea and vomiting.  I vomited through the next morning and finally stopped by mid afternoon of the next day.  I did not go to the emergency room or call my doctor because I am very healthy overall, because as an acupuncturist I am trained in health and I was able to keep myself from getting dehydrated, and because due to living for many years in developing countries. I have some experience with acute bouts of intense illness and felt able to monitor myself.
Red blotchy skin on my chest and neck. Vertigo and an intense headache that started on the top of my head and ?traveled? to the base of my head. I was given Benadryl for the splotchy skin, Dramamine for the vertigo and Tylenol for the headache. My husband picked me up from work and I slept on and off for 4-6hrs.
on 4/20/21,  9 am (24hrs after receiving the second shot, he complained that the couldn't breath and his throat hurt, we gave him some tylenol,) then we call 911 by 3pm because he looked pale.  by 6pm we were told that he was going uptown, because he might need a ventilator.  Then at 12:30 a.m. on 4/21/21 we were told he was alert and in emergency diaylsis and he should be okay.  Then they called us at 8 a.m. to say that he had passed away due to a heart attack.
Cellulitus at site left upper arm; Prevnar flu given 1/4/08; Admitted 1-15-08 -> 1-18-08 1/23/08-records received for DOS 1/15/08-ED report presented with C/O fever since night before. Temp 103.8. Left upper arm with tender induration 2cm in diameter on lateral aspect, no fluctutation. Right upper arm lateral aspect with needle mark and mild swelling, no redness no tenderness. Impression Arm abscess.   3/27/08-DC Summary received for DOS 1/15-1/18/08 DC DX: left arm cellulitis. leukocytosis. Fever.
First dose- severe headache and nausea, vomiting for about 24 hrs, some arm pain, fatigue Second dose-same symptoms, some fever on and off, still going on now, not 24 hrs since onset has passed yet, though
covid vax 5/18 and 6/8/2021 developed diff splenic infarct noted on ct 7/17/2021 h/o sickle cell trait
About 10 minutes after receiving vaccine patient got a hive on her lip - was given 2 benadryl- continued to feel scratchy throat, then got hives on chin, ear and chest. Nose was scratchy also. Started to feel nauseated. Never had or complained of difficulty breathing. Patient sent to ER accompanied by husband. Was given prescription for steroids and sent home. Spoke with patient after leaving ER about 2:15 pm and was stable.
The Moderna vaccine induced my menstruation. I am currently breastfeeding and had not been menstruating since becoming pregnant in January 2019. I had a baby since then and due to nursing on demand my period had not returned. Less than 24 hours after getting vaccinated I woke up to a moderate menstrual flow, bright red blood. I am still menstruating and experiencing mild cramping and bloatedness in my abdominal area. There was no prior indication this would happen before the vaccine. I had not even spotted before. My cycle has historically been very regular and I am certain the vaccine had something to do with stimulating my endocrine system and thus causing my menstruation.
6JAN92 pt recvd dose of Engerix-B & 10JAN92 devel neuritis & s&s consistent w/GBS; pt hospitalized for 8 days; MD performed CT Scan & Lumbar spine both neg; orthopedic consult proved neg; 17JAN92 pt ambulatory & recovering from events;
14 days p/vax pt devel a widespread maculopapular rash on torso that spread to extremities;the rash lasted 2wks;pt BP 140/90;had no fever or other sx;exp pruritus w/rash
This case was reported by a pharmacist via call center representative and described the occurrence of mobility decreased in a 80-year-old male patient who received SHINGRIX (batch number 32PE4, expiry date 23rd January 2021) for prophylaxis. On 2nd July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced mobility decreased and pain in arm. On an unknown date, the outcome of the mobility decreased and pain in arm were recovered/resolved. It was unknown if the reporter considered the mobility decreased and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient could not lift his arm for 2 weeks after receiving SHINGRIX. He did not have any redness or swelling, just soreness where he could not lift his arm. The patient was fine at the reporting time. The reported batch number belongs to the adjuvant of SHINGRIX.
After 5 days, noticed a weird pain in the lymph node that hurts my arms, now after a week a bump in the injection site which still hurts. Upper arm limited movement
Pimply itchy Rash in both arm pits, on abdomen, groin area. Filling this out on day of reaction now 2:00pm and still has a rash
Fever, joint aches, chills, headache lasting from about 11:00 p.m. the night of the vaccination date through around noon the following day.
syncope immidiately after vaccination - dizzy and nauseated - relieved with ice packs and 12 minutes of waiting.
Eye burns; chills; Pain; headache; eyes hurting; balance problems/balance off/equilibrium was off; This is a spontaneous report received from a contactable consumer (patient) via medical information team. A 72-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot Number: EL9262), via an unspecified route of administration, administered in left arm on 17Feb2021 at 14:30 as single dose for covid-19 immunisation. Medical history included covid-19 in Sep2020. There were no concomitant medications. On 18Feb2021 at 11AM, she experienced, chills, pain headache, eyes burning, eyes hurting, balance problems/ balance off, equilibrium was off. She had a bad reaction. It was 3 days of being in bed. She was fine now, she feels great since Sunday afternoon. She had covid in early Sep2020, and in Oct2020 she had 2 tests that came negative, so she knows it was not in her system anymore, but when she got phone the call for covid vaccine thought she should get it. In Dec2020 she did have the covid virus, and asked if this would have any influence on having the vaccine. She does not know that if she had the covid virus in the past, she didn't know if she should have gotten the shot. She called her doctor, and they told her that she should not have gotten the shot, she spoke to a NP, even though she had virus, she shouldn't have gotten it. She was told to rest comfortably as long as she was feeling better. She had 2 negative tests within a week before seeing her doctor. In order to even see the doctor 2 negative tests are required before an appointment can be made. Her second dose was scheduled on 11Mar2021 at 2:30pm. With experiencing these symptoms, she asked if she could get the second dose. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
muscle cramps; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (muscle cramps) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCLE SPASMS (muscle cramps). At the time of the report, MUSCLE SPASMS (muscle cramps) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant products were not provided.  Treatment medication were not reported.  Company comment: 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.; 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. Injection site soreness (L. bicep) started 78 min post IM inj. administered by Pharmacy 2. Joint soreness bilaterally in shoulders 3. Low grade fever (98.8-99.1) developed overnight and has continued. Took 1x Tylenol 500 oral route to counteract and will continue to monitor.
Rash throughout her upper body / ER Visit Required / still have not resolved; Throat tightening / ER Visit Required / still have not resolved; Trouble breathing / ER Visit Required / still have not resolved; Coughing / ER Visit Required / still have not resolved; This case was reported by a consumer via call center representative and described the occurrence of rash in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th December 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 26th December 2020, several hours after receiving Shingrix, the patient experienced rash, throat tightness, difficulty breathing and cough. The patient was treated with steroids nos (Steroids) and antihistamine. On an unknown date, the outcome of the rash, throat tightness, difficulty breathing and cough were not recovered/not resolved.   It was unknown if the reporter considered the rash, throat tightness, difficulty breathing and cough to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's husband. The patient had her 2nd dose of Shingrix and a few hours later, she began to experience a rash throughout her upper body, throat tightening, trouble breathing and coughing. She had to go to the Emergency Room on 28th December 2020 for these symptoms and again on 31st December 2020 for these same symptoms. She was being treated with steroids and antihistamines. These symptoms still had not resolved. The reporter consented to follow up.
10 days ago pt recvd MMR/HIB & today fever to 104, no rash, little cranky this AM; mom asked to have pt seen; Other than t101.4 pt was alert & no other findings; dec appetite;
At first/after injection, only slight warm feeling, followed within an hour by a feeling that the "needle was left in muscle". Within 4 hours (5:00 pm) feeling dizzy, light headed, nausea. Next am, noticed swelling and heat at injection site. Still felt as if needle was left in. Noticed tingling/burning radiating down rt arm (injection arm) to thumb, accented by any prolonged use of rt arm. During day 2 still noticed/felt warmth and could not lay on/have any pressure on or around injection site. Felt general malaise and feverish to touch. Day 3 still having pain upon pressure around site, still warm feeling, still tingling/burning down to thumb on rt arm, only slight feverish feeling, and more energy. Today, so far only the issue with the pressure to/around injection site, which is limiting my being able to work around house and on my vehicle, which is made worse yet by attempting to and using my rt arm---painful---like after being stabbed or shot in first few days after surgery---
Patient and his wife received  a Covid19 vaccine on 04/12/2021 Approximately three days after receiving the vaccination  they started experiencing  the following symptoms: tiredness, loss of appetite, nausea and some vomiting. On 04/17/2021 extreme diarrhea developed and they went to their primary care doctor. The doctor prescribed antibiotics. As of 04/26/2021 the symptoms were still occurring but less severe.
Vaccine stored improperly; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine stored improperly) in a 59-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021 at 2:35 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine stored improperly). On 13-Apr-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine stored improperly) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications or treatments were reported.
This spontaneous report was received from a pharmacist referring to an approximately 67 year old patient of unknown gender. Concurrent and medical history were not reported. Pharmacist reported that in 2013, the patient with no increased risk for PNEUMOVAX 23, at the age of 65 years (Lot number, expiration date, dose and site of vaccination were unknown), then, in December 2014 was administered a dose of PREVNAR 13 and finally on 0-JUN-2015, the patient was revaccinated with a second dose of PNEUMOVAX 23 (Lot number, expiration date and site of vaccination are unknown). There was no adverse events reported. Additional information has been requested.
patient had a red, swollen, and throbbing arm with temporal thermometer temp of 100.7 in arm and just now starting to subside
Consumer received her third dose of GARDASIL 9 on 26-MAY-2022 and is 4-6 weeks pregnant; no adverse event; This spontaneous prospective pregnancy report was received from a female consumer of unknown age reporting on herself. On 26-MAY-2022, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route and lot # not reported). The patient reported she was 4-6 weeks pregnant. The patient stated the nurse administered the vaccine at the beginning of the appointment, before patient spoke with her doctor regarding the GARDASIL 9 vaccination and pregnancy. The patient's last menstrual period and her estimated date of delivery were unknown.