chrisvoncsefalvay/vaers-outcomes huggingface dataset:
About 1-week post second injection, patient developed Pulsatile Tinnitus in (R) side. This has continued for two (2) months after the second injection. Additionally, patient has complained of excruciating headaches on the right side of the head, behind the eyes and behind the ear. Patient has throbbing head pain, and becomes lightheaded easy. Blood pressure has increased to a perceived new normal of 140/90+ on most days, even at rest. Patient is normally very active, exercising at least six (6) days per week doing cardio and strength workouts, however has not been feeling well since the second shot. Patient is very fatigued by the end of the day, which is not normal. Patient wakes up in the morning to pounding headaches, pain level 5-7, every single morning with a perceived fast heart rate. Pulsating tinnitus is very loud for patient, and he cannot hear out of that ear, and difficult to understand speech or other sounds. No change in diet, working conditions or lifestyle other than receiving the COVID-19 vaccination.   Patient has been monitoring blood pressure at home with a machine and at the clinic. Average blood pressure is 143/90 with some readings as high as 160/95 and as low as 118/80 (after waking up on day 3 of a hospital stay). Patient was admitted to a hospital on 21JUN21 for abnormal ECG, high blood pressure and complaint of chest tightness, debilitating headache as well as pulsating tinnitus in head.
Thyroid Stimulation Hormone less than 0.01, thyroid med decreased, no change
Heavy menstrual bleeding lasting one day. Of note, patient has had most recent Mirena IUD inserted in spring of 2020 and has not had a menstrual period at all with IUD inserted prior to this. IUD placement was confirmed by patient after episode. In addition, patient experienced a similar episode of vaginal bleeding several days after first Pfizer dose three weeks prior. Timing of effect coupled with patient's typical lack of menstrual periods is highly suggestive of vaccine correlation.
Next day  unstable 1/26-1/27-1/28 Seizures  1/26- 1/27 -1/28 Behaviors 1/26-1/27-1/28 Total  incontinence 1/26-1/27-1/28 Eye swelling 1/28-1/29 Red bicep 2/8 - 2/12
felt delirious; he had chills; fatigue; neuralgia; This serious case was reported by a consumer via call center representative and described the occurrence of delirium in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31-OCT-2023, the patient received the 1st dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced delirium (Verbatim: felt delirious) (serious criteria GSK medically significant), chills (Verbatim: he had chills), fatigue (Verbatim: fatigue) and neuralgia (Verbatim: neuralgia). The outcome of the delirium, chills, fatigue and neuralgia were resolved.   It was unknown if the reporter considered the delirium, chills, fatigue and neuralgia to be related to Shingrix.     It was unknown if the company considered the delirium, chills, fatigue and neuralgia to be related to Shingrix.   Additional Information: GSK Receipt Date: 16-NOV-2023 The patient that hours later he had chills, fatigue, neuralgia, and felt delirious.  The next day his symptoms subsided.  Referred him to health care professional (HCP), MI phone number provided. The reporter did not consent to follow-up.
Achiness; Malaise; This case was reported by a consumer via call center representative and described the occurrence of pain in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th August 2019, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain and malaise. On an unknown date, the outcome of the pain and malaise were recovered/resolved.   It was unknown if the reporter considered the pain and malaise to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient's wife. The reporter stated that the patient experienced malaise and achiness from his first dose of Shingrix. The reporter had called to also inquire about receiving Twinrix and Covid-19 vaccine booster. The reporter consented to follow-up.
Seizure; Fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) via .  A 6 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 26Nov2021 09:45 (Lot number: Fk5618) at the age of 6 years as dose 2, single for covid-19 immunisation in Pharmacy/drug store. Relevant medical history included: "Epilepsy" (unspecified if ongoing). Concomitant medication(s) within 2 weeks of vaccination included: OXCARBAZEPINE, complete multivitamin, immune-c. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Fk3127, Location of injection: Arm Right, Vaccine Administration Time: 03:30 PM), administration date: 05Nov2021, when the patient was 6 years old, for Covid-19 Immunization. The patient was not diagnosed with COVID-19 prior to vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. The following information was reported: SEIZURE (medically significant) with onset 27Nov2021 05:15, outcome "recovering", described as "Seizure"; PYREXIA (non-serious) with onset 27Nov2021 05:15, outcome "recovering", described as "Fever". The events "seizure" and "fever" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: body temperature: (27Nov2021) fever. It was unknown if therapeutic measures were taken as a result of seizure, pyrexia.   Follow-up attempts are completed. No further information is expected.
no additional AE's; The HCP reports that a patient was administered an expired dose of RECOMBIVAX HB.; This spontaneous report has been received from a medical assistant, referring a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant medications were not provided.  On 19-JAN-2023, the patient was vaccinated with an expired dose of hepatitis B vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection 0.5 milliliters (lot number T033149 has been verified as a valid lot number, expiry date reported as 18-NOV-2022, but upon internal review determined as 19-NOV-2022) (strength and frequency were not reported) indicated as prophylaxis (expired product administered).  No additional adverse event were reported.
The patient came to the pharmacy around midday complaining of persistent dizziness since the evening on day of vaccine (5/24/22). I advised him to call his doctor as soon as he can.
2-3 days of brain fog - memory difficulty, struggling to focus. This then led to an episode of severe emotional effects over the course of a single day with no rational reason - no prior stress or anxiety leading to the episode. Best described as "someone flicking a switch on my emotional state". The day prior I was happy, productive and positive. On the day of the episode for no apparent reason anything could be a trigger for an emotional response - e.g my daughter performing a cartwheel was enough to be overwhelmed with emotion. Everything felt dark and negative for no apparent reason and was outside my control. My wife described me as "a different person" on this day. The following day, it was like the switch had been flicked again and I was back to my normal self.
Headache frequently, joint pain, disorder, anxiety nasal allergy, eyes allergy, itching, back pain
Initial misuse report received from a healthcare professional on 04 June 2013. An 8-year-old patient had received a dose of DAPTACEL. No adverse event was reported. List of documents held by sender: none.
Systemic: Other- pt had history of copd and DNR on file. approx 3 1/2hr after vaccine pt had sob and lowo2 sat, emergency services called, pt passed on their arrival.staff felt due to pt existing condition
SEIZURE; DEHYDRATION; This spontaneous report received from a pharmacist concerned a 19 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included dehydrated, anxious, non alcohol user, non smoker, and penicillin allergy, and other pre-existing medical conditions included the patient did not had history of drug abuse or illicit drug use. the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 on right deltoid for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, the patient had an seizures with in 1 minute after vaccine administration which was lasted for 10 second. The patient did not had history of seizure. The patient was taken to hospital via ambulance and they found that she was dehydrated and was given fluids. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from seizure on 16-MAR-2021, and the outcome of dehydration was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210332197 -JANSSEN COVID-19 VACCINE Ad26.COV2.S-Seizure, Dehydration. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Prone to infection after Covid-19 vaccine. Developed bacterial and fungal ear infection after the Modena vaccine. Had previously developed a sinus infection (self diagnosed, not reported) after first Pfizer vaccine, and developed a testicular infection after the 2nd dose of Pfizer (reported in V-SAFE, not in VAERS, visited doctor for treatment).
Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash Generalized-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Abdominal Pain-Mild, Systemic: Autoimmune Disease (diagnosed by MD)-Mild, Systemic: Bell's Palsy-Mild, Systemic: Blood Disorder  (diagnosed by MD)-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Cardiac Disorder (diagnosed by MD)-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Chills-Mild, Systemic: Confusion-Medium, Systemic: Diarrhea-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Fever-Mild, Systemic: sweating-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Mild, Systemic: Heart Attack-Mild, Systemic: Hypertension-Mild, Systemic: Hyperventilation-Mild, Systemic: Hypotension-Mild, Systemic: Joint Pain-Mild, Systemic: Lymph Node Swelling-Mild, Systemic: MIS (Multisystem Inflammatory Syndrome)(diagnosed by MD)-Mild, Systemic: Nausea-Medium, Systemic: Neurological Disorder (diagnosed by MD)-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Seizure-Mild, Systemic: Shakiness-Mild, Systemic: Stroke-Mild, Systemic: Tachycardia-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Tinnitus-Mild, Systemic: Unable to Sleep-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Vomiting-Mild, Systemic: Weakness-Mild, Additional Details: after giving him the pfizer shot and the flu shot, he suddenly said he didnt feel well, as I was grabbing a water  and blood pressure machine, he fainted and was not responsive. we called 911 but after about 7 to 10 seconds, he woke up and his color was flushed and he had profuse sweating. we gave him water and had him stay in observation till he was feeling ok to leave, i called him today and hes is feeling fine. He did mention that before he had come to get his shots, he had thrown up that am.
Information has been received from a health professional, for the Pregnancy Registry for Gardasil, concerning a 26 year old female who on 03-APR-2007 was vaccinated with a first dose of Gardasil (lot number unknown) IM. On 06-JUN-2007 the patient returned for a second dose of Gardasil and a beta-human chorionic gonadotropin test (unspecified) was conducted and the results were positive. The patient received her second dose of Gardasil. Patient returned on 26-JUN-2007 and received a second dose of Gardasil at that time and the patient was no longer pregnant. No further information was available. The date of the last menstrual period and the estimated time of delivery is unknown. Follow-up information was received. The patient had no pertinent medical history or drug reactions/allergies. The patient had a spontaneous abortion "4/07" from LMP. It was unknown if the products of conception were examined. The fetus was not normal. In May 2007 a diagnostic laboratory test was performed during pregnancy. No further information was available. Upon internal review spontaneous abortion was considered to be an other important medical event (OME). Additional information is not expected.
Information has been received from a physician concerning a female patient who in approximately May 2007, was vaccinated with a dose of Zostavax. It was reported that in approximately May 2007, the patient experienced significant redness, warmth, and pain 48 hours post-injection. The patient was diagnosed with cellulitis and was treated with cephalexin (KEFLEX). At the time of report, the patient was recovering. A product quality complaint was not involved. Cellulitis was considered to be an other important medical event by the reporter. This is one of the several reports received from the same source. Additional information has been requested.
SHORTLY AFTER THE INJECTION SHE STATED THAT HER HEART FELT LIKE IT WAS RACING, FELT HOT, DIZZY,  HAD HER REMAIN SEATED, GOT A FAN TO HELP COOL HER OFF.  SHE SIPPED ON WATER THAT SHE HAD.   TOOK HER BLOOD PRESSURE/HEART RATE WAS ELEVATED SOME.  SHE DID NOT WANT AN AMBULANCE.  AS SHE SAT THERE SHE STARTED FEELING BETTER.  SHE LEFT WITH HER FAMILY SAYING SHE FELT BETTER.
Needle came off and some of the liquid dripped down; Faulty syringe and needle came off; A spontaneous report was received from a pharmacist concerning a male patient who received Moderna's COVID-19 Vaccine, and the needle fell off and some of the liquid dripped down [Incomplete dose administered and Syringe issue].   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 18-Jan-2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   A pharmacist stated that the vaccine had a faulty syringe. She said that while she was depressing the syringe and went to pull away, the needle came off and some of the liquid dripped down.  She reported that the patient is concerned because they are not sure exactly how much of the vaccine he received. The pharmacist wanted to know if the patient needed to receive another dose of the vaccine.   Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not provided.   The events the needle fell off and some of the liquid dripped down were considered resolved on 18-Jan-2021.; Reporter's Comments: This report refers to a case of incorrect dose administered and syringe issue for mRNA-1273.  There were no reported adverse events associated with this case.
About 1.5 hours after the vaccine, I started having a dull aching headache above my eyebrows, behind my eyes & behind my cheek bones. This headache continued for 5 days. It stayed dull and constant, but it wasn't incapacitating. I continued to work with the headache. About 28 hours after the vaccine, I began to feel very tired, achy and just laid on the couch the rest of the day. The tiredness and headaches have continued ever since. I went to my endocrinologist on 4/20/2021 for my regular check up. After lab and USG of my thyroid, there were no changes. I continued having the headaches off and on (about 3-5/week). Nothing would stop them, not Motrin, Tylenol, or Aleve. I tried lying in a dark room, cool compresses, warm compresses, no sound, soothing music, nothing would stop them. Since I have a history of Renal Cell cancer and the headaches were continuing, I was worried that I might have brain metastasis. I saw my oncologist on August 10, 2021. Dr.  ordered an MRI of the brain just to check. I had my MRI on August 30, 2021. It was normal. My headaches are continuing. Sometimes, they are painful, and I have to go lie down. They continue to be 3-5 times per week.
Information has been received from a physician concerning a 77 year old female with hypertension and no known allergies who on approximately 27-AUG-2007 was vaccinated with a single dose of Zostavax (Oka/Merck). Concomitant therapy included unspecified blood pressure medication. On an unspecified night (not the same night as the vaccination) after having dinner the patient developed nausea. The patient sought medical attention at the hospital and food poisoning was ruled out. Blood work revealed the patient had thrombocytopenia, platelet count 70,000 and blood culture revealed no infection. She was admitted to the hospital. The patient had no rash. The patient "is slightly getting better" since being admitted to the hospital. No further information was provided. There was no product quality complaint involved. The patient's thrombocytopenia and nausea were considered serious for hospitalization. Additional information has been requested.  10/8/07 Patient demographics provided by CDC.  10/16/07 Reviewed hospital medical records which reveal patient experienced low blood pressure, nausea, vomiting, fever, fatigue, sore throat, dizziness, syncope.  Exam revealed hypotension, throat erythema & vesicular lesions in mouth/throat.  Admitted 9/5-9/8/2007.  Tx w/IV antibiotics & antivirals FINAL DX: UTI, septic shock, acute renal failure, thrombocytopenia secondary to septic shock.
Patient received DTaP 44 by IM injection on 09/11/02 in the left thigh in our office. Parent contacted our office on 09/13/02 reported patiuent left thigh presented with large area of redness,swelling and heat.
I had a fever, fatigue and chills for about two days after receiving the vaccine.  In 12/2022, I developed an oral mucocele on the left side.  I wrote to my primary doctor, and I was referred to an ENT.  I saw my dentist and she suspected a mucocele. At this time, I have no pain, so we are waiting and watching.
We were sick we possibly have Covid; ache; I had a fever for two days off and on; have been sick; This is a spontaneous report from a contactable consumer or other non hcp (patient). This consumer reported similar events for 2 patients. This is 1 of 2 reports. A female patient of an unspecified age received first dose of bnt162b2 (Formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced we were sick we possibly have covid, ache, i had a fever for two days off and on, have been sick. Patient stated my husband and I both got the Pfizer shot on Monday night the first dose, now we have been sick. The patient had a fever for two days off and on and ache. My husband had a fever for 3 to 4 days and could we possibly have gotten Covid from it because he is gonna take the Covid test now because we were fine before the shot but now we find we were sick we possibly have Covid. The clinical outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021416222 Same reporter/diff patient
This spontaneous report was received from a physician refers to a patient of unknown demography. The physician reported that the patient was vaccinated with ZOSTAVAX (dose, route and frequency was not reported) on 30-JAN-2013 (also reported as the year confirmed to be 2013 and not 2014) and on 07-FEB-2014. No adverse symptoms reported. No further information provided. Additional information has been requested.
Upon disease investigation of 8/21/21 case reported symptom onset of 8/13/21 which included runny nose, headache, fatigue, cough, shortness of breath, chest pain and congestion.
Patient stated had some minor tickle in throat and slight heaviness in chest. Eyes than began swell bilaterally after 25 minutes after vaccine was given.
VISION CHANGES (PT STATED ALL OF A SUDDEN SHE COULD SEE VERY FAR WHEREAS PREVIOUSLY NEEDED GLASSES, BUT HER NEARSIGHTEDNESS WAS WORSE - SENSITIVITY TO BRIGHT LIGHT), EAR RINGING, GENERAL FEELING OF SICKNESS, FATIGUE, HEADACHE, TROUBLE SLEEPING, INCREASED BATHROOM VISITS. PAIN, SWELLING, WARMTH IN INJECTION SITE.  PT HAD ICED ARM FOR PAIN/SWELLING. HADN'T TRIED ANYTHING YET FOR OTHER SYMPTOMS.
Breakthrough case admission after 3 vaccines Pfizer 4/16/21 Lot# Ew0158;  Pfizer 5/13/21 Lot# Ew0186;  12/21/21 Moderna Lot# 068H21A
Passed 37 days mark for second dose/didn't get the second dose yet; Really big knot at the side of the injection; Nausea; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Passed 37 days mark for second dose/didn't get the second dose yet), VACCINATION SITE MASS (Really big knot at the side of the injection), NAUSEA (Nausea), HEADACHE (Headache) and CHILLS (Chills) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included DULOXETINE HYDROCHLORIDE (CYMBALTA) and VENLAFAXINE HYDROCHLORIDE (EFFEXOR) for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION SITE MASS (Really big knot at the side of the injection), NAUSEA (Nausea), HEADACHE (Headache) and CHILLS (Chills). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Passed 37 days mark for second dose/didn't get the second dose yet). On 08-Jan-2021, NAUSEA (Nausea), HEADACHE (Headache) and CHILLS (Chills) had resolved. On 15-Jan-2021, VACCINATION SITE MASS (Really big knot at the side of the injection) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Passed 37 days mark for second dose/didn't get the second dose yet) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; 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, Vaccination site mass, nausea, chills, headache, a causal relationship cannot be excluded.  This report also refers to a case of product dose omission issue for mRNA-1273, lot # unknown.
On the evening of February 8, I felt heaviness in my chest. I was very tired. Around 1:30 am (Feb. 9), I woke up, shaking in bed. It was uncontrollable. I tried to get up to walk it off. My body started shaking even more. I felt as though I were having a stroke. To stop my shaking, I placed one hand over the other but that didn't work. I fell back into bed. I called 911. The person said my reactions were normal side effects. They refused to send an ambulance because they said I sounded fine.  On May 9, 2021, I started cramping. I haven't had a period in over three years. On May 13, I started spotting. This morning (May 14), I woke up bleeding.