chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.  On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was recovered/resolved. It was unknown if the reporter considered the rash to be related to Shingrix. Additional details provided were as follows: The patient self-reported the case. The age at vaccination was not reported. The patient received first dose of Shingrix approximately two months ago of reporting date and experienced rash down entire arm in which dose was received. Rash was resolved after a week. The patient had not yet received second dose of Shingrix. The patient declined to provide demographics or further details regarding event. The patient did not specify which arm rash was on and in which injection was received. The reporter did not consent to follow-up.
91 yr old female from a health care facility , who reports she was walking up her steps today and fell face forward hitting her forehead. However her daughter reports there are no steps in her room she was informed the patient fell in her room. The pt denies any syncopal event it is of note, the pt is forgetful and confused at times. She has a hx of early Dementia,   The pt was transported to the ER, during evaluation she had SB 44 no ST changes. Additionally the pt has hyperkalemia 5.4. A cxr revealed concern for LLL infiltrate therefore a ct of chest was performed. The CT head had no acute ICH. However The ct of chest revealed abnormal with Extensive cervical, axillary, mediastinal, and upper abdominal lymphadenopathy, with soft tissue fullness
ABOUT 12 HOURS POST VACCINATION THE PATIENT PASSED OUT AT HOME. PATIENT HAD NO FEELINGS IN ARMS OR LEGS AND THOUGHT HE WAS HAVING A STROKE. THE PATIENT WAS TAKEN TO THE HOSPITAL AND HAD TO BE PUT ON VENTILATOR AND REMAINED IN THE HOSPITAL FOR 3 DAYS. PT HAS MOSTLY RECOVERED BUT HAD SLOWER USE OF ARMS AND LEGS FOR 1-2 WEEKS
Sore throat on 4/11 and tested positive for COVID-19 4/22
Urine came out of me at its own will; Didn't sleep in all the night; Back pain; Temperature was 99.4; Body pain; Nauseous; Blood sugar was elevated over 400; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (Blood sugar was elevated over 400), URINARY INCONTINENCE (Urine came out of me at its own will), INSOMNIA (Didn't sleep in all the night), BACK PAIN (Back pain) and BODY TEMPERATURE INCREASED (Temperature was 99.4) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blind, Vertigo, Neuropathy, Hypertension and Diabetes mellitus.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced BLOOD GLUCOSE INCREASED (Blood sugar was elevated over 400). On 21-Jan-2021, the patient experienced URINARY INCONTINENCE (Urine came out of me at its own will), INSOMNIA (Didn't sleep in all the night), BACK PAIN (Back pain), BODY TEMPERATURE INCREASED (Temperature was 99.4), MYALGIA (Body pain) and NAUSEA (Nauseous). The patient was treated with OXYCODONE HYDROCHLORIDE (OXYCONTIN) for Back pain, at an unspecified dose and frequency. On 23-Jan-2021, BLOOD GLUCOSE INCREASED (Blood sugar was elevated over 400), URINARY INCONTINENCE (Urine came out of me at its own will), INSOMNIA (Didn't sleep in all the night), BACK PAIN (Back pain), BODY TEMPERATURE INCREASED (Temperature was 99.4), MYALGIA (Body pain) and NAUSEA (Nauseous) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jan-2021, Blood glucose increased: 400 (High) Over 400 for 8 hours. On 20-Jan-2021, Body temperature increased: 99.4 (abnormal) 99.4.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products used included trigeminal neuralgia medication, vertigo medication, neuropathy medication, high blood pressure medication, diabetes medication and stroke medication.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jan-2021: Follow-up received and added Patient demographics, medical history, concomitant medications, stop date for events and treatment provided were reported. On 09-Jun-2021: follow up received and added patient doctor had not allowed him to have the second shot.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events,   a causal relationship cannot be excluded.
pt described visual disturbances  extreme headache   muscle aches  pt   is convinced  it  has to do with vaccine  pt has previously always had pfizer
she read an article regarding a study showing a correlation between patients vaccinated with GARDASIL 9 and infertility; This spontaneous report was received from a physician via company representative, referring to an unspecified patients of unknown age and gender. Information about patients pertinent concurrent conditions, medical history, concomitant medication, previous drug reactions or allergies were unknown by the reporter.  On an unknown date, the patients were vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection as prophylaxis (concentration, number of administered dose, vaccination scheme frequency, route and anatomical location of vaccination were not reported, lot number and expiration date were unknown by the reporter).  The reporter stated, that "she read an article, regarding a study that showed a correlation between patients vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9 and infertility". It was unknown by the reporter, if any of the patients sought medical attention, if any treatment was given to the patients or if laboratories diagnostic or studies were performed.   At time of this report, the outcome of infertility was not reported.  The causality assessment between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the event of infertility was not reported.
patient had throat swelling  and was given Benadryl and monitored for 30 minutes
Post vax the patient's right thigh became red, swollen, blotchy looking, and warm to the touch.
Body aches/chills started around 7:00 on 20SEP2023.  Nausea hit at about 9:00 and then vomiting shortly after.  Had taken 2 tylenol but they came back up.  After vomiting, took 400mg ibuprofen. Today (21SEP2023) only nausea/vomiting remain.  Vomited at about 8:15 this morning.  Feeling blah (malaise) now but chills and body aches are gone.  Took 400mg ibuprofen this morning.
First dose / 11/5/2020 / she developed shingles and has had it for 2 weeks; This case was reported by a consumer via call center representative and described the occurrence of shingles in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th November 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, but was selected adult as per vaccine indication. The patient had received first dose of shingrix on 5th November 2020 and experienced shingles for 2 weeks. Patient was scheduled for second dose in March 2021, but now she will confirm  with HCP, when she can get it. No other information was reported. The reporter did not consented to follow up.
This spontaneous report as received from a physician via a company representative refers to a 56 year old asplenic male patient. On an unknown date the patient was vaccinated with PNEUNMOVAX23 (dosing regimen and frequency unknown) (lot number and expiry date unknown at the age of 40. On an unknown date the patient was vaccinated with another dose of PNEUMOVAX23 (dose regimen and frequency unknown) (lot number and expiry date unknown) at the age of 46. No concomitant medications were reported. No adverse events were reported. The outcome of the events and action taken with the therapy with PNEUMOVAX23 was unknown. The relatedness of the events to the therapy with PNEUNMOVAX23 was unknown. There was no product quality issue reported.  Additional information has been requested.
Headaches migraine type down into my neck; Headaches migraine type down into my neck; This is a spontaneous report from a contactable reporter (consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received bnt162b2 (BNT162B2), administered in right arm, administration date 02Aug2021 at 09:00 (Lot number: unknown) at the age of 50 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Motrin, reaction: "Drug allergy", notes: Known allergies: Motrin. Vaccination history included: Covid 19 vaccine (DOSE 1 SINGLE, Lot Number: UNKNOWN, Anatomical location: Right arm, Administration time: 10:00, Manufacturer unknown), administration date: 16Jul2021, when the patient was 50 years old, for COVID-19 immunisation. The following information was reported: MIGRAINE (non-serious) with onset 03Aug2021 at 10:00, outcome "not recovered", described as "Headaches migraine type down into my neck"; NECK PAIN (non-serious) with onset 03Aug2021 at 10:00, outcome "not recovered", described as "Headaches migraine type down into my neck". The events "Headaches migraine type down into my neck " and "Headaches migraine type down into my neck" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of migraine and neck pain.  Additional Information: The patient did not receive other vaccines within four weeks prior to COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19.  The lot number for BNT162b2 was not provided and will be requested during follow up.
patient fainted after vaccine and passed out while sitting in a chair briefly and woke up shortly after receiving the vaccine. After speaking with the patient this has happened to her in the past with needles and piercings.
Pt 17 years old inadvertently given a COVID-19 vaccine, Moderna.
Immediately after receiving flu vaccine, patient complained that she felt "funny" and that her tongue felt tingly.  She stated that she did this sometimes when she was allergic to something. Patient was assessed by 2 nurses, had no hives, edema, no respiratory distress.  BP was 158/72, pulse 100 and regular, respirations regular and unlabored.  Patient drank about 4 oz of water while being observed in clinic for approximately 15 minutes.  Patient left the clinic with her daughter.  She stated that she felt better, just weak.  RN recommended that patient go to ER if she did not improve.  Hospital called the Health Dept. on 9/18/2009 to report that patient had gone to the Emergency Department with respiratory distress and hives shortly after leaving the Health Department and was admitted to the hospital on 9/17/2009 and had been discharged on 9/18/2009. 9/24/09 ER rec records rec'd for DOS 9/17/09 with dx:  Allergic Reaction.  Diabetes. CAD. Pt presented with c/o airway tightness, weakness, dizziness, itching, swelling of throat and lips, trouble swallowing and lip tightness after receiving Flu shot.  Tx with epi, benadryl, and steroids. D/C home improved.
Information has been received from a medical assistant referring to a 15 months old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 09-JUN-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # K016153 with expiration date 24-SEP-2016; dose and route of administration were not reported). No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
Patient came to medical to report dizziness, lightheaded & weak at 12:22pm. Had flu vaccine this date (10-17-11) at 10:48AM. Given Ibuprofen 400mg & bed rest.
I had been at an event while out of town and ended up at parties, bars and restaurants where I was in close quarters with others and I am not sure if those people were vaccinated or not. That week before Christmas I was working a ton and only getting a few hours of sleep finishing up end of year things. However, on Sunday the 18th I was so exhausted and just slept all day. Now this is normal when I am having that lack of sleep but not to this extent where I am just exhausted and fatigued. Monday, I did have a fever and I was struggling with using OTC medications to keep the fever down. On Monday or Tuesday, I developed a sore throat and I have trouble swallowing and it was painful, I also had a runny nose and postnasal drip. The cough I had was only productive from Monday to Tuesday and it was those deep coughs to clear up the mucus. By Wednesday it was more of this involuntary cough that is mild, non-productive but you have this tightness and need to cough. I was having horrible night sweats especially Sunday night so much to where I woke up with soaking wet undergarments it looked like someone had poured water in the bed and me. By Thursday and Friday, I was getting my energy back and I was not just trying to sleep the whole time. That exhaustion and tiredness was the biggest issue and was fighting that tiredness. I took a COVID-19 home test on Monday and that was positive. The next day I went in for a COVID-19 PCR test and that was positive as well. I then had a telehealth appointment with my doctor because of the confirmed positive COVID-19 tests. He put me on PAXLOVID, and I did not really think it made an impact on getting better or not but it did make the night sweats that I was having during this worse. I have tested negative and would say that I have recovered but I do have this lingering cough that is still occurring today. On December 7th I had been put on an antibiotic for some nasal issues and that had a cough with the postnasal drip issues. I have been put on a different medication to try and help with the linger cough. I am also having some vertigo issues and dizziness issues and my doctor did see fluid behind my ears as well. My doctor indicated he was not sure if this lingering cough is from that initial issue on 12/7, and then having COVID made it worse or if I am having separate issues related to having had COVID. He did indicate that the cough seems to be related to COVID but there is nothing to really say what the root cause is. I am now on five medications to try and resolve this lingering issue.
developed a small Pulmonary embolism in Lung; Colitis; This is a spontaneous report from a non-contactable consumer (patient, self-reported).   A 84-year-old non pregnant patient female received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL9264 and expiration date was not reported), via unspecified route of administration in left arm on 11Mar2021 at 09:00, at single dose for COVID-19 immunization. The patient's medical history included Myeloma and concomitant medication was not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6201 and expiration date was not reported), via unspecified route of administration in right arm on 18Feb2021 at 09:30, at single dose for COVID-19 immunization. On 25Mar2021 at 09:30 AM patient developed a small Pulmonary embolism in Lung and Colitis, 10 days after second dose of Pfizer vaccine. The patient had received the treatment medication for the adverse event. The seriousness of the event considered as serious due to hospitalization of the patient. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and after vaccination was not tested for COVID-19. The outcome of the events small Pulmonary embolism in Lung and Colitis was recovering.   Information on Lot/Batch number was available. Additional information has been requested
4/25/13 fever > 101 could not bend (R) knee started on Azithromycin took 1 dose. Developed a full body rash 4/28 started clindamycin after rash.
3/27/03 C/O sore throat.  3/31/03 Presents to ER with severe HA starting on 3/29 and progressively worsened. Treated with IM pain medicine.  Notes muscle aches and extreme fatigue. 4/1/03 Followed up with physician who recommended off work for rest of week and po pain medicine.  Sx gradually lessened.  Stated feels "like I have the flu only 3 times worse".
Information has been received froma physician referring to a patient of unknown age and gender. There was no medical history or drug reaction/allergies reported. On 22-APR-2016 the patient was inadvertently vaccinated with a dose of (Oka/Merck) VARIVAX (dose, route and lot # were unknown), instead of the intended ZOSTAVAX (dose, route and lot # were unknown) (wrong drug administered). No adverse effect was reported. Additional information has been requested.
I had chills and difficulty controlling my body temperature, and thus difficulty sleeping. Also achiness at vaccine site.
Narrative: 75 year old male reporting that since getting the Covid vaccine on March 5, he has been noticing BMs every 5-6 days. He had some initial improvement with Dulcolax, but then didn't find it to be super helpful after about 3-4 doses, causing mostly gas without significant stool output. Last took dulcolax 3 days ago. Think he has a large stool burden currently. Denies gassy pain, fever, chills,hematochezia, melena, chest pain, palpitations, URI symptoms. No treatment given in the ED. Discharged on miralax.
Syncopal attack, 2 to 3 minutes, post vax. Fell to the floor striking right temple area; approx. 6mm abrasion to right temple from eyeglasses; estimated length of time of unconsciousness, 20 seconds; transported to hospital per father and school nurse. Her anxiety level was elevated at the thought of receiving a shot. Child's posture was rigid and eyes rolling immediately after falling. Sent home for observation with parents. Had an immediate swelling and discoloration of right temple area was evident; complained of drowsiness. Treated and released from ER. CT Scan of head-negative (except for sinusitis).
Information has been received from a Medical Assistant (M.A.) concerning a 94 year old female patient with hypertension, hypercholesterolaemia, osteoarthritis, sulfonamide allergy, allergic reaction to antibiotics (CIPRO) and history of diverticulitis, cataract and eye operation in March 2010 who in "1998" was vaccinated with the first 0.5 mL dose of PNEUMOVAX 23 intramuscularly (unspecified if the patient had any problems with the first dose). It was reported that on 26-APR-2010, the patient received the second 0.5 mL dose of PNEUMOVAX 23 (Lot # 665300/1314Y) intramuscularly. Concomitant medications included "6 medications" (unspecified). It was reported that on the same day, on 26-APR-2010, in the evening the patient experienced pain in the neck and both shoulders down her arms and in both hands. The left deltoid injection site was swollen, red, painful, warmth to the touch and 8 inches in diameter. The patient was instructed by the physician to ice the area for 10-15 minutes every few hours and take BENADRYL as directed, TYLENOL or ADVIL for the pain. It was reported that the patient "felt like run over by a truck and very painful". The patient sought medical attention via phone call on 28-APR-2010. There were no laboratory diagnostic tests performed. At the time of the report the patient had not recovered. Additional information has been requested.
The morning of April 3, staff at the Community Vaccination Clinic discovered a discrepancy in the preparation of Pfizer vaccine doses. It was discovered that several undiluted vaccine doses were administered. Staff accounted for all unused undiluted vaccine doses. Unfortunately, 10 undiluted vaccine doses had been administered to patients and were not able to be retrieved. This patient received one of the undiluted doses.   The medical team contacted the CDC to determine the potential side effects and observation requirements of receiving an undiluted vaccine. The CDC confirmed that the recipients of the undiluted doses may experience stronger side effects and symptoms than someone who received the diluted dose (sore arm, flu-like symptoms, etc.).  The site public health officer spoke with suspected recipients of the undiluted vaccine to explain potential medical side effects. The  Health District will follow up to monitor their status.
75y.o. female with a PMHx significant for asthma, breast ca, hypothyroid, HLD, and as below. Pt presents with c/o worsening chest pressure over the past week. Pt underwent stress test on 8/19 which showed myocardial ischemia to the distal anterior wall and apical wall segment. Pt has cardiac cath planned for 9/19/22. Pt states since chest pressure not improving she decided to present to ED. Pt states upon ED arrival chest pressure improved after receiving SL nitro x3. Upon ED evaluation troponin negative x1, BNP 48. Pt admitted for cardiology evaluation and underwent cardiac cath 8/21 with Dr showed very mild coronary atherosclerosis. Pulmonary consulted per cardio rec, increased symbicort doses and continue albuterol as needed. Referral given for pulmonary rehab. Discussed with nursing staff. Patient is cleared and discharged in a stable condition.
pt recv vax 9FEB98 & 27FEB98 pt devel a breakthrough rash w/10 lesions;
pt recv vax SEP97 & it was reported that pt later recv a total of four doses;30JAN98 lab eval revealed that pt failed to seroconvert;
At around 1 pm he complained of stomach pain and nausea. He was in so much pain, he couldn?t talk.
Vaccine received approx 8:40 am, heavy arm feeling started immediately; other side effects started approx 1:00 pm same day. Side effects include: fast heart rate, injection site pain, extreme tiredness, moderate headache, joint pain, fever of 102° that occurred two separate times between 1:00 pm and 11:00 pm, overall feeling unwell, decreased appetite, body aches and pain Side effects last until approx 3:00 pm 11/23/2021
RADIATING PAIN STARTING FROM LEFT LOWER BACK TRAVELLING DOWN TO LEFT LEG. PATIENT WENT TO SEE DOCTOR ON 3/28/19 AND WAS PRESCRIBED CYLCOBENZAPRINE FOR MUSCLE SPASM, HYDROCODONE W/APAP FOR PAIN, AND METHYLPREDNISOLONE DOSE PAK FOR INFLAMMATON.
1.) Diarrhea starting around 5 for evening 2.) Fever began around midnight and hit 101 at 3:00. Advil reduced fever 3.) Lethargy 4.) I started by period 3 days later the exactly like I did 3 weeks prior on my shot on 7/13 which lasted for 10 days after not having it for 7 months as hitting menopause and have an IUD.  5.)Racing heart off and on similar to when I had the Covid Virus in Feb 2020
None at time of injection 02/03/2021.  On 02/17/21 itching started on left arm at injection site.  Today, 02/18/2021, warm reddened skin with slight bumpy rash appeared.  Itching continued, but decreased as day went on.  No other noticeable symptoms.  Did NOT contact family physician.