chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a 77 year old female consumer with hypertension, elevated cholesterol, type 2 diabetes, coronary artery disease, allergy to sulfa drugs and central nervous system medications who in June 2007, was vaccinated with a dose of zoster vaccine live (Oka/Merck). Concomitant therapy included Norvasc, Aspirine, Celexa, folic acid, sitagliptin phosphate (MSD), lorazepam, fish oil, Plavix, omeprazole (MSD), Tricor, Vesicare, unspecified multi-vitamins, calcium (unspecified) and vitamin D (unspecified). On approximately 15-JULY-2007 (report as mid July 2007) the patient developed a severe right hand pain followed by pain in other areas of her body and was diagnosed by her rheumatologist with rheumatoid arthritis after immunization with zoster vaccine live (Oka/Merck). The patient is currently being treated with methotrexate and prednisone. At the time of the report the patient was recovering. There was no product quality complaint involved. Additional information has been requested.
1. same symptoms as the first injection lasting a little over 48 hours: extreme, blinding headache; intolerance to any kind of natural or artificial light; nausea; inability to eat or take daily meds without bring them back up; extreme thirst; aches and pain in every bodily joint; physical weakness--inability to walk farther then nearby bathroom; bedridden this whole time. In addition, after this second injection the swelling lasted four days,  and covered about half of the upper arm, and was too painful to the touch to apply anything. Took nothing as I couldn't keep meds down. Today is day five and I feel stronger as I can eat normally now.
This spontaneous report as received from a 61 year old female patient (occupational therapist). The patient's pertinent medical history included episode of shingles approximately in 1997 ("about 17-18 years ago") and an episode of shingles approximately in 1980 ("about 35 years ago"). The patient's current conditions included hypothyroidism, type II diabetes (does not take medications for the type II diabetes) and drug allergy to Erythromycin. On 02-JUN-2015, the patient was vaccinated with ZOSTAVAX (unknown strength), intramuscularly right biceps muscle. Concomitant medications included LIPITOR 20 mg and the patient received tetanus in her left arm on the same day she had received ZOSTAVAX. On 02-JUN-2015, the patient developed soreness at the injection site after receiving ZOSTAVAX. The patient stated that she developed overall body aches, nausea, fatigue, and intermittent diarrhea "within 24 hours" of receiving ZOSTAVAX. The patient developed swelling at the injection site where she received ZOSTAVAX on 03-JUN-2015 and then on 04-JUN-2015, she developed redness at the injection site where she received ZOSTAVAX as well as the injection site was "hot to touch". The patient's blood sugar had increased by "20-25 planks" since an unspecified date in June 2015, after receiving the ZOSTAVAX and she thought it was because she had not felt well. No lab diagnostic procedures were performed. The patient sought medical attention and was seen by an unspecified physician on 05-JUN-2015 for her symptoms listed above and she was informed by the unspecified physician to take BENADRYL and ibuprofen (unknown manufacturer). The patient took diphenhydramine hydrochloride "every four to five hours" for four days and she reported on the fourth day, the redness and swelling at the injection site decreased. The outcome of the events swelling at the injection site and redness at the injection site was resolving and the outcome of the events soreness at the injection site, overall body aches, nausea, fatigue, intermittent diarrhea, injection site was hot to touch, blood sugar had increased by "20-25 planks" and not felt well was unknown. There was no product quality complaint involved. Causality assessment was not reported. Additional information is not expected as the reporter did not wish further contact.
This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 68-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX with an associated reaction of injection site pain (2 years ago without any problems except for soreness at the injection site). Concurrent medical conditions included fibromyalgia. On 31st July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 31st July 2018, 6 hrs after receiving SHINGRIX, the patient experienced fatigue, headache, injection site swelling and injection site pain. On 2nd August 2018, the patient experienced injection site bruising. In August 2018, the patient experienced difficulty sleeping, nausea, fever and chills. In August 2018, the outcome of the difficulty sleeping, fever and chills were recovered/resolved. On an unknown date, the outcome of the fatigue, headache, nausea and injection site swelling were recovering/resolving and the outcome of the injection site bruising and injection site pain were not recovered/not resolved. It was unknown if the reporter considered the fatigue, injection site bruising, difficulty sleeping, headache, nausea, injection site swelling, injection site pain, fever and chills to be related to SHINGRIX. Additional details were provided as follows: The patient received initial SHINGRIX vaccine in the early afternoon in the left deltoid. Her left arm gradually became sore towards the evening and continues to be very sore. She reports it was at the date of reporting, she was bruised at the site of the injection and was about the size of a fifty cent piece. The patient was not sure if her fibromyalgia was compounding the pain and bruising at the injection site. The patient 12 hours post vaccination, began to have fever and chills in the middle of the night following the vaccine, along with a headache that began right before she went to bed. The patient 12 hours post vaccination, did have difficulty sleeping that night but that had resolved. The fever and chills had resolved but her other symptoms were gradually improving.  The patient 36 hours post vaccination, did suffer from nausea a day before date of reporting which was slowly resolving. The patient was not sure if she should receive the second SHINGRIX vaccine and was advised to consult with her physician on what would be best for her. The patient had provided contact details of her physician.
headache; chills; fatigue; low grade fever; This case was reported by a consumer via call center representative and described the occurrence of headache in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 3 months after receiving Shingrix, the patient experienced headache, chills, fatigue and low grade fever. On an unknown date, the outcome of the headache, chills, fatigue and low grade fever were not recovered/not resolved.   It was unknown if the reporter considered the headache, chills, fatigue and low grade fever to be related to Shingrix.  Additional case details were reported as follows: The patient stated that after receiving 1st dose experienced headache, chills, fatigue and low grade fever. The patient received the 2nd dose in February 2020. The patient had been to her regular physician and had also been seen by a rheumatologist and blood work had come back normal. The patient consented to follow up.      Lab Comments: on an unknown date blood test was done
Patient reported that she was hospitalized for COVID-19 pneumonia (for 14 days total). She received dose #1 on 12/17/20 and was hospitalized 2 days later. (unable to access these records). Reporting per EUA requirements; unknown if this was reported by the facility where she was hospitalized.
Approx 2 1/2 wks p/receiving DTP #5, pt had sz on school bus; repeated sz lasted approx 1 1/2 hrs; Pt was taken to ER & given med & was intubated; hospitalized x 1 wk;
Information has been received from a Medical Assistant (MA) concerning a 23 year old female patient with dysmenorrhoea, penicillin allergy and sulfonamide allergy who on 12-MAY-2008 was vaccinated IM into left deltoid muscle with 0.5 mL of GARDASIL (lot # 659055/1522U). Concomitant therapy included ATIVAN, LUPRON and ESTROGENS, PREMPRO. The MA reported that on 12-MAY-2008 the patient developed a "deep soreness" of the left axilla. There was no redness or swelling. No further information available. The patient had not recovered as of this report date. Additional information has been requested.
5 hrs. after injection: chest tightness, weakness, chills, loss of appetite, 1st day after: weak, body aches, loss of appetite: Rest & TYLENOL 2nd day after: weak, body aches: Rest & TYLENOL.
pt had gen sz activity lasting 3min w/no neurological deficits;+febrile sz; CT scan WNL;
Dizziness and itching at 1558.  Given po 50 mg Benadryl. Stating chest tightness 1415. Given albuterol neb, refusing epi. EMS called.
This spontaneous report was received from a physician refers to 6 patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored (temperature minimum 30F, 32.7F, 33F, 92.5 Hours, because of data logger) VAQTA lot # L004743, expiry date 01-JUN-2017, (dose, frequency and route of administration not reported). Previous temperature excursion was reported as no. No adverse events reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. This is one of three reports received from the same reporter. Additional information has been requested.
DEMAND ISCHEMIA 4/1/2023 SEVERE SEPSIS W ACUTE ORGAN DYSFUNCTION ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/1/2023 SEVERE SEPSIS W ACUTE ORGAN DYSFUNCTION
Itchy skin upper thigh groin area that flakes for a few days and then it gets worse; skin flaking; This case was reported by a other health professional via interactive digital media and described the occurrence of itchy skin in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced itchy skin and flaking skin. On an unknown date, the outcome of the itchy skin and flaking skin were not recovered/not resolved.   It was unknown if the reporter considered the itchy skin and flaking skin to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per the vaccine indication. The patient received Shingrix and had itchy skin upper thigh groin area that flakes in a pattern words itchy than it used up for a few days and then it got worse.
pt devel a maculopapular rash all over on body on 21MAY96, 2wk p/vax;pt feels fine, but tired;
COVID-19 treatment; COVID-19 treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old male patient received BNT162b2 (BNT162B2), on 16Mar2021 as dose 1, single (Lot number: EL 3302), in left arm, on 06Apr2021 as dose 2, single (Lot number: EN 6201), in left arm and on 06Nov2021 as dose 3 (booster), single (Lot number:  PH8020) at the age of 36 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19 treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: The patient previously received a COVID-19 vaccine. The patient did not received any treatment.  No follow-up attempts are needed. No further information is expected.
As discussed with patients mother no reaction to the vaccinations. Patient was given DTaP instead of Tdap
Tested NAAT positive for COVID 11/5/21 after being fully vaccinated.
I started like a cold and it's now a sinus infection. I went to the doctor because I was feeling ill. They ran a COVID-19 test and it was not COVID-19. and I'm still sick, but it feels like my normal sinus problem. I had a fever.
Patient received expired Moderna Covid-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    In April 2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The date of vial initially stored in the refrigerator was unknown. It was reported that 22 patients received expired Moderna Covid-19 vaccine. Dates of administration of vaccine were reported as 2 doses on 05-Apr-2022, 13 doses on 06-Apr-2022, 2 doses on 07-Apr-2022 and 4 doses on 08-Apr-2022.  The vial did not undergo any temperature excursions. No treatment information was reported.
pt called two days after vaccine to inform me (pharmacist) that she experienced hives on her face, ears, and back. started one hour after vaccine injection. she called her doctor's office and was advised to take Benadryl. she reports that her symptoms are much improved from initial reaction but is still needing to take Benadryl. she states she will be monitored by her PCP.
Nausea vomiting 1/15/2021 evening. Fever Saturday & Sunday body aches chills, Body aches Monday
Pt recvd vax 18MAY92 &  devel swelling & stiffness of fingers primarily involved the rt pointer, rt ring finger & the lt pinky finger; tingling & numbness;
80 year old Caucasian male with PMH including: HTN, prostate cancer (2007) s/p prostatectomy, multiple laparotomies for bowel obstruction, reported "dead" bowel s/p resection, 120 pack year smoking history quit 2019, who presents after fall onto his right side. Patient initially presented to Urgent Care, transferred to local Hospital. Patient reported at hospital that he fell 2-3 weeks ago injuring the ribs on his right side. Patient started to become more easily winded the past couple weeks, not able to walk as far when shopping etc. Patient reported he started to wake up 4-5 days ago with difficulty breathing while on CPAP. Patient was feeling not rested enough and sleeping longer periods overnight up t0 11 hours. At hospital patient was evaluated and CXR showed right sided pneumothorax, chest tube was initially placed however, unable to achieve appropriate placement and was pulled. A second attempt was made to place a chest tube with successful placement. Patient received a total of 500mcg of fentanyl during placement of chest tubes.  Patient reports history above. He tested positive for Covid-19 infection at local Hospital.
Gave pt. shingles vaccine at 11:45 on 5-18-11. She came back to clinic at 2:27 with c/o mild throat swelling & generalized body weakness. Throat swelling resolved by dc. Weakness was resolving. Given 25mg BENADRYL rx'd.
Patient was taking her blood pressure a few days after her vaccine and noted that she was tachycardic, heart rate in the 150s. She presented to the emergency department where we administered a diltiazem bolus via IV.
Pt. with new onset of numbness in lower extremities starting Sept 29 with neg rapid pcr testing then - L side starting at umbilicus and R side at knee; cognitive issues and problems with focus and working also noted.  4 new brain lesions and one thoracic spine lesions.
FATIGUE; LOOSER STOOL THAN NORMAL; SORE ARM; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1816027, and batch number: 1816027 expiry: UNKNOWN) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-MAY-2021, the subject experienced looser stool than normal. On 25-MAY-2021, the subject experienced sore arm. On 27-MAY-2021, the subject experienced fatigue. The action taken with covid-19 vaccine was not applicable. The patient recovered from fatigue on 28-MAY-2021, and had not recovered from looser stool than normal, and sore arm. This report was non-serious.
Caused her blood sugars to go sky high; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Covid-19 shots before; dose number unknown; manufacturer unknown), for Covid-19 immunisation. The following information was reported: BLOOD GLUCOSE INCREASED (non-serious), outcome "unknown", described as "Caused her blood sugars to go sky high". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Had her blood work done and doctor said she has no antibodies, so she got another shot today and caused her blood sugars to go sky high. She was asking if vaccine caused blood sugar to go up like that.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report as received from a Register Nurse refers to a 6 month old patient. On 09-SEP-2014 the patient was vaccinated with improperly stored PEDVAXHIB intramuscular injection, 0.5 ml. No adverse effect was reported. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Pt received her first dose of COVID19 vaccine on 1/13/2021 at the health department clinic. Pt then called the health department on 1/19/2021 stating once she got home her bottom lip swelled up and so did her eye lids. On 1/19/2021 the pt reported she could not speak with me (RN) further as she was about to go on a zoom meeting with her allergist to discuss the event. RN asked pt to call the LHD back.  1/20/2021 RN called pt to discuss further, pt stated she is in the grocery store and cannot speak. RN asked pt what the allergist recommended. Pt stated the allergist recommended getting the 2nd dose of the vaccine however with additional pre-medications. Pt stated she could not speak with RN further and would call me back.  1/25/2021 - pt did not call clinic back. RN called pt to get more details on the event. Pt reported her allergist would like her to get the 2nd injection in the hospital, while taking Singulair the night before and Zyrtec and Benadryl the day of. RN advised the pt her allergic reaction is a contraindication to receiving the 2nd dose per CDC guidelines. Pt verbalized understanding and will discuss with her allergist further.  Pt also mentioned possible allergy to Polysorbate during call on 1/25/2021 however she reports because she tolerates Miralax on a regular basis her allergist does not believe it to be a true allergy. Pt did not mention this in VAMS. I was not the vaccinator.
Sharp pain at time of injection high on left shoulder top of deltoid muscle.  Then just ache until 1 1/2 hours later and I could barely lift left arm without exclaiming in abrupt pain and deep ache in bicep and deltoid  increased over evening. Weakness in arm. Redness in an oval about 5" x 6" developed on upper arm developed late in evening and lasted overnight. Trouble putting arm into clothing sleeve or lifting items.  Soreness continued, disrupting sleep Aug. 8-10 and gradually dissipated.  Took Ibuprofen. Ache in injection area of left arm came back unexpectedly on August 15 night and lasted to afternoon of August 18. Then same arm pain-weakness lifting arm returned on overnight of August 20-21 and still occurring at this date August 22. Can barely use arm - much sleep disruption and activity diminished.
They start to talk to you and it can't be heard by anyone else. I had weird dreams of herd immunity and people beating me to death. I dream in 54% REM, so I sleep longer in a deep sleep and at an elevated dream level. They are making contact somehow and I believe the vaccination is allowing them to take it a step further. On top of affecting my dreams, they have started to move something around in my body. They can make my skull vibrate now if I think of a thought. I'm sure it is top secret. THEY ARE KILLING PEOPLE.
Fever of 102- 103 for about 3 days afterwards.  Infant did not smile for a few days.
Expired Havrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 45-year-old female patient who received HAV (Havrix) (batch number H4H53, expiry date 30th January 2023) for prophylaxis.   On 1st February 2023, the patient received the 1st dose of Havrix. On 1st February 2023, 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: 2-Feb-2023 Reporter's comment: Information for adverse event and vaccine was collected. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up. Additional supportive information: The patient accidentally received an expired dose of Havrix, which led to expired vaccine used.
An MD reported that a 13 mt old female received her first dose of Prevnar on 1/18/02 at 4 mts of age. On 10/18/02, a blood culture was performed; pneumococci was isolated. A Dx of bacteremia (w/out focus) was made. Pneumococcal bacteremia was considered medically important. No further info was available at the date of this report.