chrisvoncsefalvay/vaers-outcomes huggingface dataset:
blister; chicken pox; eye movement disorder; twitch of my right eye; This case was reported by a consumer via call center representative and described the occurrence of blister in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in late 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced blister, chickenpox, eye movement disorder and blepharospasm. On an unknown date, the outcome of the blister, chickenpox, eye movement disorder and blepharospasm were unknown.   It was unknown if the reporter considered the blister, chickenpox, eye movement disorder and blepharospasm to be related to Shingrix.  Additional details were provided as follows: The patient received 2nd dose and had blisters that resembled chicken pox occur after the 2nd dose. I had a much more severe reaction resulting in a return trip to my primary care physician. They verified that the blisters appeared to be like chicken pox. Soon after had an intermittent twitch of my right eye. This eye movement has worsened over time since the 2nd part vaccine.  The reporter was concerned.
Swelling, pain, tenderness, redness, heat at injection site - increasing progressively over 2 days to a max of 3 inches in diameter before subsiding. Provided ice pack and homeopathic Arnica for pain relief.
This spontaneous report was received from a pharmacist referring to a "baby" male patient of unknown age. Patient's medical history and concurrent condition were not provided. On 27-NOV-2015, the patient was vaccinated with RECOMBIVAX HB (lot # L018500) expiration 13-APR-2017 (route, dose number and anatomical location were not provided) which was incorrectly stored. This is one of five reports from the same source. Additional information has been requested.
I had the shot. Got shingle several times afterwards\ suspected Vaccination failure; Got shingle several times; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. The patient got shingle several times after receiving shot. This case was considered as suspected vaccination failure since details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were not provided.
Numb roof of mouth, tingling tongue and lips; no medications given; patient transferred to ED
This spontaneous report was received from a registered nurse and refers to a patient of an unknown gender and age. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On 16-DEC-2015 the patient was vaccinated with an expired dose of M-M-R II. lot# j014875, expiration date: 21-NOV-2015 (dose and route of administration were not reported). There were no adverse effects reported. Additional information has been requested.
pt recvd vax & w/in several hrs exp an allergic react which included swelling of the eyes, urticaria, erythema all over body (trunk, arms & legs); treatment given in office; DPH 1 ml po; scheduled to be rechecked 25MAY93;
2-3 hrs p/shots began crying-cried cont for about 3 hrs; took to ER; MD said didn't know if from shot or colic;
Hormonal dis regulation. I am very regular due to hormone therapy. About two weeks after vaccine had night sweats for a week and then started my menses on day 19 in my cycle which has never happened. Also got a yeast infection- haven?t had one of these in many years.  I have also randomly gained 10 lbs- I?m guessing due to something with my estrogen. I have also been extremely depleted feeling since the second vaccine, I?m used to low energy but this depletion has been more than normal for me. This second menstral  cycle that I?m getting ready for seems like I will start late.
Patient received his 1 st COVID 19 vaccine 1/13/2022 and today with fever( tmax 102.6 ear) this morning, vomiting x 1( "dry heave"), c/o of headache and throat pain. Decrease appetite and fluid intake.             - Last meal 1/13/22 dinner            - No rash            - No injection site redness or swelling            - No trouble breathing or swallowing            - No rash
Information has been received from a Registered Nurse (R.N.) concerning a 21 year old female patient with asthma who on 15-DEC-2006 was vaccinated IM in her right arm with a dose of Gardasil, lot #654389/0961F. Concomitant therapy included hormonal contraceptives (unspecified) and albuterol inhaler (unspecified). The patient has had difficulty lifting her right arm since she was immunized in that arm on 15-DEC-2006. The patient also experienced tingling in her arm, nausea, and vomiting after the injection. The patient was treated with physical therapy. The patient had not recovered as of the report date. Additional information has been requested.
Flu-like symptoms suddenly occurred mid-morning on the day after I received the injection including severe headache, weakness, chills, mild nausea, and muscle soreness at the injection site (left arm).  If this lasts more than 3 days, I will fill out another report.
Flu like symptoms.  Fever, chills, muscular aches, and want to sleep a lot. Had the same reactions as the second shot, but didn't report.  Took Tylenol.  Getting better the following day, but not 100% yet.
THROWING UP; SWEATING PERFUSELY; ABDOMINAL PAIN; COULDN'T EAT; LOST 10 POUNDS; COULDN'T SLEEP; SHAKING WITH CHILLS; LACK OF ENERGY; FEVER; NAUSEA; MUSCLE ACHES GOT WORST/FELT HORRIBLE; ITCHY; LETHARGIC; MUSCLE ACHES; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination.  The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 30-MAR-2021, the subject experienced itchy, lethargic, muscle aches, headache. On 07-APR-2021, the subject experienced throwing up, sweating profusely, abdominal pain, couldn't eat, lost 10 pounds,  couldn't sleep,  shaking with chills, lack of energy, fever, nausea,  muscle aches got worst/felt horrible.  Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle aches, headache, and lack of energy, and the outcome of itchy, lethargic, throwing up, fever, shaking with chills, sweating perfusely, abdominal pain, couldn't eat, lost 10 pounds, couldn't sleep and nausea was not reported. This report was non-serious.
Pt recvd vax 1DEC92 & 1 1/2 hrs following vax arm ached; pt exp soreness from the upper arm to the elbow; The entire arm felt very heavy, particularly the upper arm; On 2DEC92 arm ached for seventy percent of the day;
Pt vaccinated with Influenza red edematous area noted at injection site 3 min after injection. Pt did not bleed at time of injection or later- no bandage applied. Pt denies all questioned possible rxn- local & systemic (itching, dizzy).
The child received DTaP vaccine on Jul 16 2007.  On July 2007 am the child walked up to mom and cried his   eyes and head were hurting followed by acting dizzy/unsteady and eyes rolling back in head several times over a 2-3 minute period.  He remained standing/conscious during the entire episode and became completely normal afterwards.  He was examined in the office about 3 hours after the event and had a totally normal examination in general and neurologically.  Based on this we have decided to observe the child for the time being.  If recurrent events develop we will begin a more thorough neurological work up to include EEG and a screening laboratory evaluation.  As the mother was concerned about the event in relationship to the recent vaccine we decided to make this report to VAERS to be complete and make sure others have not had a similar event.
6:30am on 9/15/21 She came into the kitchen complaining to me of a headache. I gave her motrin and when she went to the sink to rinse out the medicine cup she lost consciousness. she eyes rolled in the back of her head and her whole body went limp. I grabbed her and carried her back to bed. In bed she was unresponsive to her name and was hot to the touch. I called her primary doctor who told me to bring her to the ED right away. She was seen at a Hospital on 9/15/21 at 7:30am.
Patient has suffered headache, extreme fatigue, loss of appetite, chills, nausea, extreme weakness, weight loss and confusion.  This is the sixth day of feeling these symptoms without improvement.  We have called the doctor to discuss symptoms, he showed no surprise as he stated that other patients have called in with similar symptoms. He said to call back in a week if symptoms have not let up.
This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. There was no concomitant medication. Information about concurrent conditions and medical history was not provided. On 25-APR-2017 at 10:00 am, the last recorded temperature of the vaccines was 4 Celsius degree. On the same day at unspecified time, the ROTATEQ were discovered out of temperature range (refrigerator temperature was 12.7 Celsius degree). The vaccines were not moved to a working refrigerator post the event. It was also reported that the vaccines experienced a temperature excursion during 1 hour 17 minutes. No previous temperature excursion was reported. A data logger issue was involved. On 27-APR-2017, the patient was vaccinated with improperly stored doses of ROTATEQ (lot number M039067 with expiration date of 18-APR-2018; strength and dose were unknown; location was also reported as "2", dose number was also reported as "0"; Vaccines for Children Program (VFC) stock) orally for prophylaxis. The nurse sated that they would monitor every 30 minutes to insure temperature with range. It was confirmed the vaccines were OK to use. There was no adverse event reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA014144:
During injecting, vaccine leaked out of needle from opposite end. Due to this, the exact dose the patient received could not be determined. Arm was cleaned with alcohol pad and patient reported no skin irritation following. ACIP and MD (Dr. per employee 2/26/20) recommended revaccination as this was most likely a sub-therapeutic dose. Patient agreed to come in for revaccination. She did not end up coming in and she was then contacted again a few times in April to come back. She did end up coming in 5/23/20 and received the revaccination. First dose of shingrix was received on 11/14/2019.
LEFT BREAST TUMOR AND LYMPH NOE REMOVED 10/28. REPORTED IN RETROSPECT TO HAV A FASLE POSITIVE FINDING ON THE LYMPHNODE DUE TO COVID VACCINE AS REPORTED BY PHYSICIAN
Gave patient Varicella #2 injection SQ in her right thigh, within 5-10 minutes doctor went to check on her and saw a reaction of a hive appearance where injection was given at site.
One week later, decedent experienced shortness of breath, diarrhea, pneumonia, hypoxia, elevated troponin
Client felt all the covid 19 symptoms  on 02/05/2021 . tow day after secon dose , went o ER was tested and is positive for covid. today still vary weak and with diarrhea.
knee pain; slight back pain; throat tickling; This case was reported by a consumer via call center representative and described the occurrence of throat irritation in a 64-year-old male patient who received Rabies NVS (RabAvert) for prophylaxis.   The patient's past medical history included animal bite. Previously administered products included Rabavert (1st dose received on unknown, please refer the case US2020146787) and Rabavert (2nd dose received on unknown, please refer the case US2020AMR148390). Concurrent medical conditions included diabetes. Concomitant products included warfarin, immunoglobulin human normal (Gamma Globulin), paracetamol (Tylenol) and benadryl (nos) (Benadryl).   On an unknown date, the patient received the 3rd dose of RabAvert. On an unknown date, unknown after receiving RabAvert, the patient experienced throat irritation, knee pain and back pain. On an unknown date, the outcome of the throat irritation was recovered/resolved and the outcome of the knee pain and back pain were not recovered/not resolved.   It was unknown if the reporter considered the throat irritation, knee pain and back pain to be related to RabAvert.  Additional case details were reported as follows: The age at vaccination was not reported. The reporter stated with every Rabavert shot he experiences throat tickling which goes away after a day.  The patient experienced ongoing knee pain and ongoing slight back pain.  The reporter consent to follow up. This is 3 of 5 case reported by same reporter for same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR148390:
Vaccine was left out for 48 hours and was administered; Vaccine was left out for 48 hours and was administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was left out for 48 hours and was administered) and PRODUCT STORAGE ERROR (Vaccine was left out for 48 hours and was administered) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 056A22A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 19-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was left out for 48 hours and was administered). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was left out for 48 hours and was administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was left out for 48 hours and was administered) and PRODUCT STORAGE ERROR (Vaccine was left out for 48 hours and was administered) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.  It was reported that number of doses is 1 dose. On 17-MAY-2022 vial was initially stored in the refrigerator. Vial did not undergone any temperature excursions. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) is a little less than 48 hours.
pt was seen in the Medical Center, ED with c/o tingling face, mouth, throat, headache and feeling of difficulty breathing within 30 min after receiving vaccine
Caregiver received vaccine 2/1/21  started having muscles aches and body weakness, fever 101.8 that same night. Started taking Tylenol. On 2/2/21 in the evening, Caregiver noticed a rash on face and chest which progressed to entire body on 2/3/21 after taking a shower. Caregiver took a Benadryl. Caregiver called health care center on 2/3/21 at 13:41. Advised of current symptoms. Caregiver instructed to go to either call 911 or have someone drive her to nearest ER immediately. CG states she had no difficulty breathing and spoke easily on the phone to a RN.  2/4/21 RN called Caregiver who advised she was at the stand alone ER by her house by 3pm on 2/3/21, they took her back immediately. Benadryl IV, Solumedrol IV x2, and fluids given. States that when she got to the ER that her glands were swollen. Caregiver was discharged  from ER at 0330 2/4/21 with instructions to take Benadryl for the next two days or as long as symptoms last per ER physician. Caregiver instructed to go to the ER immediately for any re-occurring symptoms. States today 2/4/21 0900, only symptom is slight redness on chest and site of injection, otherwise asymptomatic. Again this RN advised CG to go to ER immediately for worsening symptoms or call 911. She verbalizes understanding.
Client fell to floor in waiting area after receiving varicella vaccine. Pale face, breathing. Ammonia inhalent crushed and placed undern ose. Neuro status Vd x 3. Cool wet towel applied to face and forehead.
The family came and said they had an appointment for COVID-19 Pfizer vaccine for second dose. The intern missed to check when the patient has the first dose which is on 6/20/2021. The second dose vaccine was administered sooner than 21 days according to CDC recommendation. The second dose is administered on 7/1/2021.  The pharmacy is tried to reach the patient family right away but no one picked up the phone.
About 5 minutes of receiving the flu shot, pt started feeling faint, hot/cold flashes, low pulse, and sweating.  Was told to stay still and sit down and rest.  Found out he hadn't eaten or drank anything today except for apple cider vinegar.  He was given orange juice (drank whole 16oz) and water.   After using rest room shortly after, he remained in pharmacy waiting area for observance for 30 minutes.  He did mention he was starting to fell like he was having a migraine and took some excedrin.  He left with his partner stating he was feeling much better.  Called the patient at 1pm and said he was feeling better but still not 100%.
Patient received his COVID booster 11/10/2021. Patient came in on 12/09/2021 to let me know that he has had intermittent right arm and right leg pain. Reports he believes related to vaccine as it started day after the vaccine and has been intermittent since receiving the vaccine.   Described right arm pain as cramping and tender with movement. Described right leg pain as pins and needles. Reports right leg pain does not interfere with walking and not bothersome with walking
tachycardia requiring ER visit and IV administration of digoxen.  First episode in 15 years.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old male patient received BNT162b2 (BNT162B2), on 11Jan2021 as dose 1, single (Lot number: ek4176), in left arm, on 01Feb2021 as dose 2, single (Lot number: el3247) and on 20Sep2021 as dose 3 (booster), single (Lot number: fc3184) at the age of 78 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 16Feb2022 as dose 4 (booster), single (Lot number: wtfou2jdia), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19.
patient accidently received  IPOL already completed their series of IPV  NO AE; patient accidently received IPOL who already completed her series of IPV /NO AE; Initial information regarding an unsolicited valid serious case was received from a nurse via regulatory authority and transmitted to Sanofi on 05-OCT-2020.  This case is linked to case 2020SA278035 (same reporter).  This case involves a 8-years-2-month old female patient who accidently received once IPV (VERO) [IPOL] (strength: standard lot number: R1D973M, expiry date: 17-Jul-2021 via an intramuscular route in the left deltoid) and not the prescribed INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (wrong product administered) on 05-Oct-2020 for prophylactic vaccination. Patient had already completed her series of IPV (extra dose administered).  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  It was an actual medication error case due to wrong vaccine administered and extra dose administered.(latency: same day).  The clinic was thinking the IPOL was given due to inventory showing a missing IPOL that should be there. Nurse reporting that it was not sure if the IPOL was given but the inventory was leaning toward the IPOL being given. The clinic staff that administered the vaccine was not sure if IPOL or the flu vaccine was given.   At the time of reporting, patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
After receiving my second dose of Pfizer vaccine on April 8th, I?ve started having neurological problems after 3 days on April 11th.  Muscle ache, weakness, numbness, tightness, tingling and very sensitive to cold in my right leg, right arm and fingers and toes. After 4 1/2 months and multiple visits to emergency room and seeing different doctors, I?m still having these issues.
PATIENT'S SPOUSE REPORTED THAT THE AREA OF THE VACCINCATION HAD BECOME INFECTED. Patient WAS TAKEN TO THE HOSPITAL AND TREATED WITH AN ANTIBIOTIC. SHE REPORTED PAIN, REDNESS, AND SWELLING 24 HRS POST VACCINATION ADMINISTRATION.
Presyncope.  Was walking around lake and for about 45 minutes I felt like I was going to faint.  I never did faint but I had to stop and rest.  This has never happened before when I was walking or running or anything.  I still feel the remnants of that feeling today 1 day later but otherwise ok.   The episode had nothing to do with low blood sugar as that is a completely different feeling.  This felt like a blood flow to brain issue.
fever; Initial information received on 20-Jul-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional via call center via Regulatory Authority (Reference number- 00690406).  This case involves male patient who experienced fever (pyrexia) when received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and HPV VACCINE.  The patient's past medical treatment, vaccination, concomitant medication and family history were not provided.  Stated he did receive a COVID vaccine at another time and only had a fever for two days.  On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious fever (pyrexia) unknown latency following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  No laboratory data reported.  It was not reported if the patient received a corrective treatment for the event.  The event outcome was unknown for pyrexia.  There will be no information available on the batch number for this case.
Slight fever, significant swelling, redness, heat of upper arm extending to elbow so by 24 hours entire upper arm involved. Beginning to resolve at 48 hours.
(+) Chicken pox disease-15 vesicles after exposure. Received Varivax on 6/26/96.