chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On Tuesday, February 16, I received my 1st Moderna Covid vaccine. On Tuesday, March 16, I received my 2nd Moderna Covid vaccine at 11AM and Eylea shots (one in each eye) at 2PM. I have been receiving Eylea every 3 months for about 3 years in one or both eyes.   On Saturday, March 20 at about 11:30AM, while sitting at traffic light, I saw what appeared to be a translucent sheet of plastic cover the left driver's window and the left half of the windshield. This was only visible in the left eye. Twenty seconds later, a yellow opaqueness developed in the left eye, which eventually cleared, but vision was still blurry. When I got home, I called my retinologist. He recommended I go into a dark room and close my eyes. At this time, I had white translucent vision in the lower left quadrant of vision in both eyes. My retinologist sent me to Hospital Emergency Department, which is part of Hospital. After being assess at Eye Emergency Room, I was admitted to Hospital for a right occipital lobe stroke that was confirmed by multiple MRIs of the head. I was told that I was experiencing an ocular migraine (although I had no pain.) I was discharged on Monday, March 22, on Eliquis. As of April 15, all of the yellow opaque and white translucent visions are gone. However my left eye vision remains blurred and hazy. I have since been diagnosed with age-related cataracts in both eyes and a fast-moving cataract in top portion of left lens. I will also report this occurrence to the reporting system.
She has not eaten anything; Diarrhea; This is a spontaneous report from a contactable consumer (patient) received through Pfizer sponsored program. A 82-year-old female patient received first dose of BNT162B2 (Pfizer Covid-19 Vaccine, Formulation: Solution for injection, Batch/Lot number was not reported) via, an intramuscular route of administration, administrated in left arm on 22Jan2021 at 10:00AM as 1ST dose, single for COVID-19 immunization. The patient medical history included as diabetes. The patient concomitant medications included as Metformin two tablets in the morning, and one tablet at night by mouth taken for diabetes. On 27Jan2021 patient experienced with diarrhea and patient was calling about the Pfizer Covid vaccine. Everything was fine. Patient had the corona virus first shot on 22Jan2021. On 27Jan2021, the patient experienced diarrhea. On an unspecified date, the patient patient had not eaten anything today. Patient had diarrhea for a day or two. Patient called her doctor for an appointment and Patient was told that diarrhea was a sign of the coronavirus and that patient should go to urgent care. Patient was asking if this was true. patient was confused and in shock, now patient was scared patient may have coronavirus. patient was told that even though patient had the shot could still have the coronavirus. Patient had diarrhea once or twice. patient not had any diarrhea today but patient had not eaten anything today. Patient had to go back 13Feb2021 for the second shot. Patient was not given a card and patient cannot provide lot, ndc, or expiration date. Patient called the doctor and they said no they wouldn't see her because that is a sign of the coronavirus and wants to know if that is true since she already had the first shot. No further details provided. Unable to provide an email address. Declines report and wants to speak to someone about this. The outcome of the event resolved on 29Jan2021 and outcome of remaining event was unknown.  Information about lot/batch number has been requested.
Site: Pain at Injection Site-Severe, Additional Details: patient states excruciating pain at injection site think at the joint advised to check with dr. reviewed with immunizer and was given in correct location to avoid shoulder joint
Been a year since 1st dose, 2nd not yet; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 28-SEP-2022 Reporter's Comments: The case was reported via interactive digital media. It was more than a year since the patient received first dose of Shingrix.  The patient asked was there any concerns with getting his/her second dose now. Additional Supportive Information: Till the time of reporting the patient did not receive 2nd dose of vaccine, which led to incomplete course of vaccination.
PATIENT CAME TO PHARMACY AFTER GOING TO DR OFFICE WITH COMPLAINTS OF ARM RED AND SWELLING. DR PRESCRIBED ANTIBIOTIC.
4/10: lump under injection site, fatigue, headache, extreme lower left back pain (which lasted almost 7 days).  4/11:silver dollar size red spot at injection site. Not ichy or raised. Lump remained and warm to touch. Shoulder tenderness 4/14: lump remains, red, war and now raised.  4/16-4/18 (today): lump bigger than silver dollar, firm, more red, warm, raised lump pushes out further on skin,  itchiness comes and goes.
This spontaneous report as received from a physician refers to a patient of unknown age and gender, who "sometime this week", on approximately 13-AUG-2012, was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported). No other co-suspects were reported. No concomitant medications were reported. The physician reported that unspecified patient was vaccinated with ZOSTAVAX "sometime this week" and was admitted to an unspecified to an unspecified hospital for an unspecified medical reason yesterday 16-AUG-2012. The patient had sought medical attencion. Physician noted that the admission to the hospital was not related to ZOSTAVAX but for another unspecified medical reason. Physician did not want to give any additional information for the adverse event (AE). No treatment information was reported. The relatedness for adverse event was unknown for ZOSTAVAX. Additional information is not expected.
HARD TIME THINKING; BURNING IN THE ARM; FAST HEART RATE AROUND 120-130  BPM; SENSITIVITY TO LIGHT; BODY ACHES; CHILLS; DIARRHEA; HEADACHE (HEAD KILLING HER); FEVER OF 103F; NAUSEA; This spontaneous report received from a patient concerned a 30 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: non smoker, social drinker, penicillin allergy, iodine allergy, and drug allergy (Erythromycin Zoloft). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855194, expiry: 09-APR-2022) dose was not reported, 1 total, administered on 27-DEC-2021 at around 12:30 PM on left arm for prophylactic vaccination (Dose number in series 1). Concomitant medications included acetylsalicylic acid.  On 27-DEC-2021, the patient experienced burning in the arm after the shot, patient took Benadryl because she was scared. Around at 19:00-20:00 patient started having symptoms of body aches, chills and fever 103 F (Fahrenheit), nausea, diarrhea, patient's watch recorded heart rate around 120-130 BPM (beats per minute) and her head was killing. The symptoms were getting worse until 02:30 or 03.00 in the morning. Her fever broke 100.9 F after she took Tylenol 500 mg (milligram). But at the time of reporting she was still experiencing headache (head killing her) and sensitivity to light. Tylenol was not helping her headache. Later at the time of reporting she reported that she had a hard time thinking. She called her doctor but haven't heard back from him. The patient had tested positive for ANA (Antinuclear antibodies) antibody. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever of 103f, had not recovered from headache (head killing her), sensitivity to light, and hard time thinking, and the outcome of burning in the arm, body aches, chills, diarrhea, fast heart rate around 120-130 bpm and nausea was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211260926-covid-19 vaccine ad26.cov2.s -Hard time thinking. 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).
I had my moderna vaccine on January 9th  at Public Health, and had a mildly sore arm for one day.  I checked in with vsafe each day when prompted and noted no reactions.  Ten days later, January 19th,  I had a blood test in the same arm.  That night, my arm, at the vaccination site, became  itchy, swollen , sore and red.  I am advising you of this.   Do I need to be concerned.  COVID-19 Moderna Modernatx, Inc., Lot# 012L20A, exp:  7/6/2021
Immunization given 08/04/2005.  Now on 08/17 at site of MMR 5cm diameter induration and heat.  No rash or fever.  To apply ice, cool compresses, Tylenol and Motrin.
Local reaction, redness, swelling, hot and painful to touch. Reaction continued past 72 hours after receiving the injection.
No additional AE; patient received 2nd dose of GARDASIL 9 on 11/16/2022 when she was 2 weeks pregnant; This spontaneous report was received from a physician and refers to a 29-year-old female patient.  The patient's pertinent medical history, current conditions, drug reactions or allergies and concomitant medications were not reported. At the time of the adverse event occurrence, the patient was in the 2th pregnancy week. The patient's last menstrual period was estimated to be on 02-NOV-2022. The due date was estimated to be on 09-AUG-2023. The outcome of the pregnancy was pending at the time of the report.  On 16-NOV-2022, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 ml, lot #W001498, expiration date: 15-SEP-2024, administered for prophylaxis (strength, and route of administration were not provided) when she was 2 weeks pregnant (exposure during pregnancy). No additional adverse events details or product quality complaints were reported (no adverse event).
STARTING DAY AFTER VACCINATION AND CONTINUING FOR 4 DAYS THUS FAR - WORSENING FLU-LIKE SYMPTOMS - ACUTE BODILY ACHES AND RESPIRATORY CONGESTION. SINCE THE DURATION AND INCREASING SEVERITY OF THE SYMPTOMS ARE ATYPICAL; HEADING TO EMERGENCY OUTPATIENT CLINIC ASAP.
Initial and follow-up information has been received from a 76 year old white male with a history of hernia and 2 colon cancer operations, no drug reactions/allergies and no illness at the time of vaccination who on 04-FEB-2008 was vaccinated with pneumococcal 23v polysaccharide vaccine IM (lot# 656233/0200U) subcutaneous in the right arm at 2:40 PM. Secondary suspect therapy on the same date included zoster vaccine live (Oka/Merck) (MSD) in his left arm. Other concomitant therapy included vitamins (unspecified) and asthma medications (therapy unspecified). On 04-FEB-2008 the patient experienced severe pain in the right arm when he went to bed that night. On 05-FEB-2008 at 10 AM the patient had swelling, redness and was sore at the injection site. The redness spread to under the arm and into the armpit area. The patient also experienced swelling and redness about 6 inches down his arm and 3 inches wide. The patient also developed fever, chills, sweating and feeling of being lightheaded. Medical attention was sought. However the patient's right arm is still sore and he feels lightheaded. The symptoms lasted approximately 72 hours before receding. On 07-FEB-2008, the patient had recovered. Additional information is not expected.
Site: Pain at Injection Site-Mild, Systemic: Chills-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Additional Details: pt was waiting 15 min post shot and began feeling lightheaded and passed out/fainted. he came back to quickly and was accompanied by pharmmacist and wife until ems arrived. ems checked vitals and all were normal. he was escorted to car and declined hospital visit. checed in with wife 2 hours later and he was resting on couch and feeling better.
Medical Tech calls to report vaccine given during an excursion.  No PQC. No further AE; No further AE; This spontaneous report was received from a consumer and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (recombinant Human albumin (rHA), subcutaneous injection, one time, lot number w038815 that had been verified to be valid with expiration date: 04-JUN-2024, administered for prophylaxis (strength, and route of administration were not provided).  On 17-AUG-2023, the vaccine was given during an excursion (Product storage error). No PQC. No further AE.
Redness around site of injection which spreaded farther down her arm each day. Slight swelling and very slight itching. No pain.
Started with severe chills and shakes. Nausea and diarrhea. Severe headache, chills and fever (101.4). Arrived home about 7pm and fell asleep for 3 hours.  Blood pressure was up to  (159/82). Pulse (120). Unable/no desire to move. Called facility around 11pm with concern instructed to alternate Tylenol and Ibuprofen for fever. Started Tylenol and Ibuprofen around 1am (once I had some delivered). By morning only had a slight headache but was gone by late afternoon. Continue to have fatigue.
This case was reported by a other health professional and described the occurrence of wrong route of administration in a adult patient who received FLUARIX. On an unknown date, the patient received FLUARIX (intranasal). On an unknown date, an unknown time after receiving FLUARIX the patient experienced wrong route of administration. On an unknown date, the outcome of the wrong route of administration was unknown. It was unknown if the reporter considered the wrong route of administration to be related to FLUARIX.
Case number PHEH2015US021585, is an initial spontaneous report received from healthcare professional and QA department (reference number: 1007902) on 21 Oct 2015. This report refers to a 41 year old female patient. Historical condition and concomitant medication were not provided. The patient was vaccinated with FLUVIRIN (batch number: 1516401) intramuscularly on 15 Oct 2015. It was reported that while drawing out vaccine from the vial leakage was observed from the point where diaphragm and metal meet. Further it was also reported that there was no harm caused to patient and no medical attention was required. No adverse event was reported following this event.
Reports feeling dizzy w/associated tingling to tongue, throat and hands; medical monitoring x 30 min w/ symptoms subsiding Vitals assessed: BP 125/82  HR 68 O2 sat 99% RA Released from facility w/family member, plan f/up PMD as needed
COVID vaccine breakthrough case. Moderna 3/27/21 018B21A, 4/24/21 043B21A and boosted 11/30/21 012H21B.
Developed extensive DVT with pulmonary emboli 4 days after receiving Covid vaccine. Clot was evacuated with thrombectmy but reaccumulated 1 day later, despite being treated with Eliquis.
A non-serious report of inadvertently given FLUMIST  has been received from a health department representative concerning a 16-year-old female, subsequent to FLUMIST. The patient's past medical history included being 20 weeks pregnant. No concomitant medications were reported. On 16-Oct-2008 a patient who was 20 weeks pregnant was inadvertently administered FLUMIST. There was no adverse event associated with this pregnancy. Treatment and reporter/sponsor causality assessments are not applicable. The reporter was asked to inform when the pregnancy has ended and also to inform if the patient experiences any adverse events during pregnancy.
Patient described adverse event as "activation of Raynaud's" in bilateral hands.  Symptoms began within about 15 minutes of vaccination and began to resolve in about 30 additional minutes. Patient left facility without additional incident.
After 2nd vaccination (FLUVIRIN) pt stopped breathing and lost consciousness. Epi-pen administered, and pt regained breathing/consciousness. Ambulance arrived shortly thereafter.
Sneezing; Sore throat; Runny nose; This is a spontaneous report from a contactable consumer (Patient).   A 39-year-old male received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, on an 17Feb2021 (age at the time of vaccination was 39-year-old) as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 18Feb2021, the patient experienced sneezing, Sore throat and Runny nose. Caller states he got his first dose of the Pfizer Covid vaccine a couple of days ago on Wednesday, 17Feb2021. Caller states starting yesterday 18Feb2021, he has sore throat, runny nose and sneezing. States today it was more of a throbbing throat pain, it comes and goes, very random, like when you feel like you are about to get sick. Wants to know if these symptoms are normal. Caller states he was currently at work and was just trying to get answers about his symptoms. Outcome of all the events was not recovered.   Follow-up attempts are completed. No further information is expected
Daughter came in on 9/7/19 to report that her mother passed away. She reported that patient was complaining to  friends 8/15/19 thursday night of soreness due  shingrix.  on the same day 08/15/19 at about 9:20pm her grand daughter was texting her but is  she is not making sense anymore. She was found deceased on 8/18/19 , decomposed and autopsy report's caused of death is Coronary Artery Disease.  She was  cremated on 8/20/19 Tuesday
positive for covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (positive for covid-19) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (positive for covid-19). At the time of the report, COVID-19 (positive for covid-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
My arm became very red (like a sunburn) from the injection site down to the crook of my arm and itched intensely for 3 days or so.
Arm was getting infected with cellulitis; Right wrist getting tight; Hot to the touch; This case was reported by a nurse via call center representative and described the occurrence of cellulitis of arm in a 80-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th December 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 9th December 2019, less than a day after receiving Shingrix, the patient experienced cellulitis of arm (serious criteria GSK medically significant), joint tightness and skin warm. The patient was treated with sulfamethoxazole + trimethoprim (Bactron) and vancomycin. On an unknown date, the outcome of the cellulitis of arm, joint tightness and skin warm were recovered/resolved.   It was unknown if the reporter considered the cellulitis of arm, joint tightness and skin warm to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix and then went to play tennis that afternoon and he felt his right wrist getting tight and it was hot to the touch. The patient went to the doctor and his arm was getting infected with cellulitis and they put him on oral Bactron. The cellulitis started to get worse so,he went to the emergency room and they administered Vancomycin and his issue resolved. The follow up consent was granted.
This spontaneous report as received from consumer, as part of a marketing research program, refers to a 52 year old female patient reporting on herself. On an unknown date since 1998 the patient has been vaccinated with several doses (5 x since 1998 up 6 7 doses (not sure)) of PNEUMOVAX23. There was no concomitant medication reported. In approximately 2010 the patient received the 7th dose of PNEUMOVAX23, after this dose (only at last dose) the patient experienced high fever and flu symptoms. Action taken regarding therapy with PNEUMOVAX23 was reported as discontinued. The outcomes of flu symptoms and high fever were reported as recovering/resolving. The patient considered the adverse events to be not serious. The patient also considered the adverse events to be related to PNEUMOVAX23. Additional information has been requested.
chills in evening after vaccination, chills next day in AM then nausea and body aches, temp 102.
Admitted after motorcycle accident. He was found to have suffered a large epidural hematoma, sagittal sinus fracture, comminuted bifrontal fractures, and frontal sinus fractures. He was taken to the OR on 09/15/2021 for bifrontal craniotomy and repair of his facial fractures. He also required placement of a trach on 09/15/2021. It was determined that admission to Rehabilitation was necessary to allow for safe discharge back to home. 11/2/21- ED visit for acute headache - treated and released. Received second COVID vaccine while in the hospital,
Fluttering Heart; Metallic Taste in her mouth; This case was reported by a consumer via call center representative and described the occurrence of heart fluttering in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th October 2020, the patient received the 1st dose of Shingrix (intramuscular). In October 2020, 4 hrs after receiving Shingrix, the patient experienced heart fluttering (serious criteria GSK medically significant) and taste metallic. On an unknown date, the outcome of the heart fluttering and taste metallic were unknown.   It was unknown if the reporter considered the heart fluttering and taste metallic to be related to Shingrix.  Additional details were provided as follows: Approximately four hours after receiving Shingrix, the patient had a metallic taste in her mouth and a fluttering heart. The patient was advised to consult with her physician. The reporter did not consult to follow up.
He got his vaccine, immediately had regular side effects with some minor dizziness, which lasted until that weekend.   He regularly goes to the gym, usually runs about 7 MPH, and could not do that and took it easy as he felt it was due to the vaccine.  That weekend he looked in the mirror and saw a breakout on his face, looked like a bunch of blood vessels that erupted underneath his skin, but was gone within a couple of days.  His friend had the vaccine and was showing the normal symptoms of headaches, he had them but were very very mild, he still has a lump in his arm that is black and blue.  The skin appeared to be peeling and now it's black and blue.  It is concerning that when he goes to reach he has the lump that is black and blue.    He is able to do his regular exercises now, but is afraid of getting the 2nd shot.
pt recv vax 2DEC98 1PM & same day devel h/a, stomachache, itching & rash described as itchy pimples;itching was still present evening of 7DEC98 but 9DEC98 sx gone;