chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of feeling bad in a adult male patient who received SHINGRIX (batch number CH2X7, expiry date 25th April 2020) for prophylaxis. On 18th April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced feeling bad. SHINGRIX was discontinued. On an unknown date, the outcome of the feeling bad was unknown. It was unknown if the reporter considered the feeling bad to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported feeling bad after the 1st dose of SHINGRIX. Badly enough that they had put off getting the 2nd dose and are now after the 6 month window.
Headache, Sedation, Myalgia, Arthralgia, Fever, Pain/Redness @ injection site Narrative:
My menstrual cycle  was late by 2 weeks and I had the most *severe* cramping of my life. It began at 5:00 am with low to moderate levels of cramping. By 6:30 am I was fully awake and waiting for the local CVS to open at 8 am so I could purchase ibruprofen. (I NEVER have to take ibruprofen due to cramping).  I ate food before I took 200 mg - an hour later my symptoms had progressed to include doubling over in pain and nausea at which I ate a little more food and took 400 mg more (total 600 mg). At 600 mgs my symptoms abated enough for me to eat a small breakfast (10 am). 4 hours later the nausea and severve doubling over with pain cramps returned which is when I ate more food at took another 600 mgs of ibruprofen.  I went to bed at 7pm that night (usual bed time is 9:30)  I used ibruprofen to manage my symptoms all that first day ? the next day I was exhausted from feeling so beat up the day before but thankfully no more cramping or nausea. Today is day 3 and I am feeling back to myself.   I would just like to reiterate that I have NEVER in my life had a period this severe in cramping or nausea.
6/23/06 PM Per mom, patient complained of feeling ill and had low grade fever. Fever up to 104.6 with vomiting, headache, neck pain. Started on Zithromax 6/24/06. Taken to ER 6/25/06 due to no improvement in symptoms. Patient in to see doctor at office 6/26/06.
patient received an expired dose of Twinrix; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 38-year-old male patient who received HAB (Twinrix) (batch number 4F3YY, expiry date 1st January 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th January 2023, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 6th January 2023, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional Information: GSK Receipt Date: 06-JAN-2023 Reporter's Comments: The pharmacist reported that today (on the day of reporting), a patient received an expired dose of Twinrix. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up via email. Additional Supportive Information: The patient received Twinrix beyond the expiration date, which led to expired vaccine used.
Mother states her face and tongue became swollen. Denied the baby having any trouble breathing or swallowing.
I had weird feeling sensations in my chest for a couple weeks before the heart attack after the vaccination I was hospitalized and diagnosed with congestive heart failure and that I have an 2nd heart attack in April of 2022 where they went through my wrist and balloon to my artery some more. I'm still in the process of being treated for the congestive heart failure that I now suffer from due to the vaccine.
rash on my back; is a mild case ofshingles?; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 week after receiving Shingrix, the patient experienced rash and shingles. On an unknown date, the outcome of the rash and shingles were unknown.   It was unknown if the reporter considered the rash and shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 08-NOV-2022 Reporter's comments: This case was reported by a consumer via interactive digital media. The patient reporter that he/she had a rash on his/her back one week after receiving first dose of Shingrix.  The reporter asked could this be a side effect. The reporter asked as it was a mild case of shingles. Additional Supportive Information: Follow up would not possible, as no contact details were available.
The pt developed dizziness, nausea, and vomiting for one week occurring 3 days post vax.
Eyes red & painful. Sore throat. Sneezes. Right deltoid - red area warm to touch.
FAMILY PRACTICE was  notified by a County coroner that the  patient died on 12 June 2021. It is unknown to us if this is related to the Moderna vaccine received 19 May 2021.  Dr. had seen this patient one time as a new patient of FAMILY PRACTICE to establish a primary care provider 25 May 2021  FAMILY PRACTICE provided the 1st dose Moderna vaccination 19 May 2021
This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 12-OCT-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F: In September of 2015, the coldest temperature was 34 F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34 F for 492.6 hours for a total of 839.9 hours (35 days); In November of 2015, the coldest temperature was 34 F for 192 hours, for a total of 1,031.3 hours (43 days)) VAQTA injection, 0.5 ml (lot # L018499, exp. date: 25-FEB-2017) (route and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
After taking the vaccine I was very fatigued, nauseous, dizzy, massive almost intolerable headaches, and severe muscle pain everywhere except the injection site. I was going through hot and cold spells. I had no energy and just wanted to lay down, and I didn't even feel comfortable laying down. My vision was also being affected but that was probably because of the head pain. I had the same side effects with the Johnson vaccine which lasted 7 days, and now this Moderna one that lasted 5. What is worse is that about a month later I started having problems with my legs. I woke up one day and could not walk. After 4 days of leg weakness and inability to walk, and some stomach problems. I went to the ER.
Spontaneous vitreous hemorrhage in right eye 46 hours after receiving shot.  Dr. reluctant to attribute to vaccine, and he MAY be correct, but I thought I should report it as a possible adverse event.  Hemorrhage dissipating after 2 weeks and expected to clear completely.
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 68-year-old female patient received BNT162b2 (BNT162B2), on 19Aug2022 at 13:15 as dose 3 (booster), single (Lot number: FM9992) at the age of 67 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, Lot number: ER8727), administration date: 27Mar2021, when the patient was 67-year-old, for Covid-19 immunization; BNT162b2 (Dose 2, Lot Number: ER8729), administration date: 17Apr2021, when the patient was 67-year-old, for Covid-19 immunization. The following information was reported: CHILLS (non-serious) with onset Aug2022, outcome "unknown"; HEADACHE (non-serious) with onset Aug2022, outcome "unknown", described as "Headaches"; BURNING SENSATION (non-serious), PARAESTHESIA (non-serious) all with onset Aug2022, outcome "unknown" and all described as "I had burning and tingling running across the knuckles of my right hand; base of the toes on both feet"; FATIGUE (non-serious) with onset Aug2022, outcome "unknown", described as "I had fatigue, spent two full days in bed"; VACCINATION SITE LYMPHADENOPATHY (non-serious) with onset Aug2022, outcome "unknown", described as "I had swelling of the lymph nodes in the right arm pit where the injection site was"; DIARRHOEA (non-serious) with onset Aug2022, outcome "recovered" (Aug2022), described as "I had two days of diarrhea"; PARAESTHESIA (non-serious) with onset 19Aug2022 at 13:30, outcome "unknown", described as "I had pins and needles shooting up my shoulder, up to the right side of my neck"; MUSCULOSKELETAL PAIN (non-serious), PAIN (non-serious) all with onset 20Aug2022, outcome "unknown" and all described as "I had burning pain under my left scapula". The events "i had swelling of the lymph nodes in the right arm pit where the injection site was", "i had pins and needles shooting up my shoulder, up to the right side of my neck", "i had burning pain under my left scapula", "chills", "i had fatigue, spent two full days in bed", "headaches" and "i had burning and tingling running across the knuckles of my right hand; base of the toes on both feet" required physician office visit. Therapeutic measures were taken as a result of vaccination site lymphadenopathy, paranesthesia, musculoskeletal pain, pain, chills, fatigue, headache, diarrhea, burning sensation, paranesthesia. Additional information: Within the 15 minutes after the injection patient had pins and needles shooting up shoulder, up to the right side of the neck. Treatment received was 200 milligram Ibuprofen, Icepack. Patient reported this to doctor and is fully informed on the list of adverse events that was experienced from the booster. That was really bad. No follow-up attempts are possible. No further information is expected.
Daily rapid heart racing, heart rates over 110 bpm daily, missed periods, migraines, increased anxiety due to heart racing, vasovagal syncopal.
This spontaneous report was received from a health care professional regarding to 2 patients who were under the age of 19 years and of unknown gender. Information on their concurrent condition, medical history and drug allergies were not reported. On an unknown date in February 2016, the patients were vaccinated with VAQTA (lot, expiry date, route and anatomical location were not specified) strength 50/1.0 U per ml (inappropriate schedule of drug administration). Concomitant medication were not reported. No adverse events reported. There was no Product Quality Complaint (PQC) involved. Additional information has been requested.
Starting a couple days after the vaccine, there has been a mild pain in my left arm under the vaccine site. Skin is not affected. It lasted for a long time and only in the last few days is going away. I told the pharmacist a couple weeks ago and he recommended I take 3 tablets of ibuprofen twice a day, which I did for a few days and it helped. Now when I feel a little pain I take ibuprofen. It is feeling much better but I wanted to report it. I am marking "patient recovered" as "unknown" for now, but I think I am almost completely recovered.
Starting the night of the vaccine, pt had severe muscular pain in the back and side and severe constipation, both of which required her to visit the hospital
On 11/27 patient visited the pharmacy and informed me of her adverse reaction after receiving the SHINGRIX vaccine. Patient reported the next day after her vaccination, she experienced tongue swelling and hives on her body especially the back. Patient reports taking Benadryl oral medication and the swelling subsided. I recommended for her to seek a follow up with her primary care prescriber or Urgent care as soon as possible. She still had some swelling on her face but was speaking normally.
I day after vaccination, patient had erythema in left deltoid region. 2 days after vaccination, (day of physician visit), patient with onset warmth, swelling and erythema. Patient has full range of motion of left arm and no complaints of pain.
swelling; severe headaches; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A female patient received BNT162b2 (COMIRNATY), as dose number unknown, 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: SWELLING (non-serious), outcome "unknown"; HEADACHE (non-serious), outcome "unknown", described as "severe headaches".  Additional information: It was reported that after taking Comirnaty that she experienced swelling and severe headaches. The dosing was over a year ago. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt indicated that about 1/2 hour after flu shot, she started experiencing "ache from fingers to base of head" on arm that received vaccination.  In addition, pt feels "out of it".  Said she has been taking some Advil and icing area.
pain, redness, swelling @ site of TD inj; lt inner upper arm hard, swollen, red, warm to touch;
Information has been received from a nurse concerning an approximately in her 70's who on 17-MAR-2009 was vaccinated with ZOSTAVAX (Merck), 0.65ml, subcutaneously, lot number 663775/1789X. The nurse reported that the patient developed from large rash at the injection site, with a small bump also at the injection site. This reaction developed on 18-MAR-2009, the day after vaccination and only lasted 1 day. The rash was described as itchy and spontaneously resolved. The site was not interested in PCR analysis. The patient was recovered on 19-MAR-2009 and sought unspecified medical attention by phone. No further information available. Additional information has been requested.
administered an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received HBV (Engerix B) (batch number 4EA77, expiry date 11th September 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 26th September 2022, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 26th September 2022, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 06-OCT-2022 Reporter's Comment: The medical assistant reported that a dose of Engerix B inadvertently given to the patient and it was already expired.  The health care professional declined to provide additional information.  The reporter reported that the patient was a employee. The reporter did not consent to follow up.  Additional Supportive Information: The use of Engerix B dose, which was already expired on 11th September 2022, which led to expired vaccine used.
on 10Aug2022 vial was initially stored in the refrigerator, Expired on 10Sep2022, administered on 19Sep2022; no adverse event; patient received expired doses of the Moderna Vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received expired doses of the Moderna Vaccine), PRODUCT STORAGE ERROR (on 10Aug2022 vial was initially stored in the refrigerator, Expired on 10Sep2022, administered on 19Sep2022) and NO ADVERSE EVENT (no adverse event) in a 27-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 001M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Sep-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 19-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received expired doses of the Moderna Vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (on 10Aug2022 vial was initially stored in the refrigerator, Expired on 10Sep2022, administered on 19Sep2022) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received expired doses of the Moderna Vaccine), PRODUCT STORAGE ERROR (on 10Aug2022 vial was initially stored in the refrigerator, Expired on 10Sep2022, administered on 19Sep2022) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (patient received expired doses of the Moderna Vaccine) and PRODUCT STORAGE ERROR (on 10Aug2022 vial was initially stored in the refrigerator, Expired on 10Sep2022, administered on 19Sep2022).    No concomitant medications were reported. Patient not received other vaccines within 1 month prior to Moderna COVID-19 vaccine It was in the original box, but it was the last vial left.  The vial size was 5.5 ml. The vial was initially stored in the refrigerator on 10-Aug-2022. The vial did not undergo any temperature excursions. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-648026 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 20-Sep-2022: Follow-up received contains no new information; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-648026:First patient case
Information has been received from a health professional concerning a 11 year old male who on 21-AUG-2007 was vaccinated with the second dose of Varivax. Concomitant therapy included hepatitis A virus vaccine (unspecified). On 23-AUG-2007 the patient had 8x10 area that was hot and hard to the touch. Antibiotics were started. The patient's outcome was not reported. The reporter felt that this was an other important medical event. No further information is available.
This spontaneous report was received from a registered nurse refers to patients of unknown age (gender unspecified). On an unknown in 1991, the patients were vaccinated with (Merck) VARIVAX, (lot number, expiration date and route not reported). No concomitant medications were reported. On an unknown in 1991, the reporter stated that she had seem many pediatric patients; mostly severely handicapped, nursing home pediatric patients where she worked had reactions to (Merck) VARIVAX with chills, spike in temperature and turning pale. The outcome of the events were unknown. This is one of the several report received from the same reporter. Additional information is not expected.
Case number PHEH2012US015689 is an initial spontaneous report received from a healthcare professional on 07 Aug 2012. This case refers to a 12-year-old patient of unspecified gender. This patient was vaccinated only with MenCWY-135 liquid component of MENVEO (batch number: M11033) without being reconstituted with Men A component of MENVEO 09 May 2012. Thus this patient received only partial dose of MENVEO. No adverse event was reported. No other information was available.
SEVERE diarrhea (as with the first one), extreme fatigue, body aches.  It has been over 3 weeks and still experiencing off bowel movements along with fatigue.
On Friday 1/11/19 developed spots on chest. Went to the doctor and it undetermined if they were due to the SHINGRIX. Saturday developed a rash on chest, side and back. Went to the doctor on Monday where it was determined I definitely  had shingles. I was given a prescription Gabapentin 300 mg and also Lidocaine patches. It is one week today and the rash has increased on back, side and chest and is very painful. and debilitating. Had the original shingles shot on 4/17/2013 without side effects.
Information has been received from a 70 year old male consumer with no pertinent medical history who on 04-SEP-2007 was vaccinated with a dose of Zostavax. Concomitant therapy included ALTACE, COREG and INSPRA. On 09-SEP-2007 (five days after vaccination) the patient developed severe dizziness. Unspecified medical attention was sought. No lab studies were performed. No further information was provided. There was no product quality complaint involved. Additional information is not expected.
Headache, Rash, NauseaVomiting, Chest Pain Narrative:  Had chest pain for 3-5 minutes. Took Aspirin and pain went away.
This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. A patient of unspecified age, ethnicity and gender received PREVNAR 13 (0.5 ml, lot number and expiration date not reported), via an unspecified route of administration on an unspecified date at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced pain at injection site. Outcome of the event was unknown. Information on lot number, batch number and expiration date has been requested.
devel fever, unsteady gait;began vomit;to hosp;test revealed 496 WBC, 50% monocytosis, 43% neutrophils;dx w/ meningitis;did not have exposure to varicella; analysis of CSF pending at time of report;
Chest pain and worsening SOB,  Covid +,  3 L home O2 , put on 6L in ER via nasal Cannula.  He recently was diagnosed with COVID-19 on 11/4. He subsequently received monoclonal ab treatment. He received his booster 10/31.
Pt vax w/series of 3 hep B; 3 months after last vax titer was neg.
Headache, malaise, myalgias, nausea. All sx began about 24 hrs after administration (5-6-11).
Presented to urgent care and was seen by Dr. who noted:  Diagnoses: chest pain, shortness of breath, sinus tachycardia, pregnancy Vitals - BP 142/86, pulse - 123, respirations - 22, temp - 97.8, SpO2 - 100%, glucose - 285 Patient with intermittent  chest pain for the past 1.5 weeks. Patient thought it could be reflux. Decreased appetite. SOB and vomiting X2 days. Chest pain started about 1-4 weeks ago, onset is sudden and happens every several days. Waxing and waning in subsegmental region, mild, sharp, non-radiating.   Sent to ER and seen by Dr. who noted: Complaints of chest pain. History of Present Illness: SOB, chest heaviness, abdominal pain with newly diagnosed pregnancy today (9/26). Patient stated that last time she was in DKA was about 1 year ago. She has been compliant with medications and is a patient of endocrinologist. Her symptoms started again yesterday with accompanied vomiting and she hasn't been able to keep anything down. Denies dysuria or fever.  RN noted: patient complains of chest pain for past couple weeks. SOB and vomiting since yesterday.  Dr. did H&P and noted: complaints of chest pain. History of Present Illness: 2-day history of chest pressure, SOB, vomiting and hyperglycemia. Also complains of some lower quadrant abdominal and suprapubic tenderness. Has been attempting to control blood sugars and buying insulin over-the-counter since she can't get refills from her endocrinologist office. Patient denies missing insulin doses. Ultrasound of abd/pelvis. Chest XRay showed no acute process, labs show DKA. Diagnoses: Concern for non-compliance with insulin due to prescription difficulties Accelerated HTN Chest pain Pelvic pain