chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This initial spontaneous report as received from a lawyer regarding a case in litigation refers to a female patient of unknown age. The patient's medical history, concurrent conditions, and concomitant medications were not provided. On 16-JAN-2014, the patient was vaccinated with ZOSTAVAX (dose, route, and lot number not provided) as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended and, on an unspecified date in 2014, the patient contracted a persistent strain of herpes zoster. On or about 02-SEP-2014, the patient was treated for a persistent vesicular rash which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain, suffering, and other damages. The outcome of vaccination failure and herpes zoster was unknown. The reporter considered vaccination failure and herpes zoster to be related to ZOSTAVAX. Additional information has been requested.
Lethargy; achy joints; muscle pain/spasms; spasms; severe headache; low grade fever; This is a spontaneous report from a contactable nurse (patient) reported for herself. A 40-years-old non-pregnant female patient received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, batch/lot number: EW161), via an unknown route of administration in left arm on 17Apr2021 at 16:15 (at the age of 40-years-old) as dose 2, single for COVID-19 immunization at pharmacy or drug store. The patient's medical history included Multiple sclerosis, Depression and anxiety. She was allergic to food allergy (beets). Concomitant medications included within 2 weeks of vaccination were vortioxetine hydrobromide (Trintellix), ocrelizumab (Ocrevus) and fexofenadine hydrochloride (Allegra 12 hour). The patient received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, batch/lot number: EP7534), via an unknown route of administration in left arm on 25Mar2021 at 16:00 as historical vaccine as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 17Apr2021 at 18:00, the patient experienced lethargy, achy joints, muscle pain/spasms, severe headache and low grade fever. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. No treatment received for the adverse events. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
PT. STATED PRIOR TO VACCINE THAT SHE HAS SEVERE ANXIETY AND GETS VERY ANXIOUS WITH INJECTIONS. PT. PLACED ON STRETCHER PRIOR TO INJECTION. FIVE MINUTES AFTER INJECTION PT. C/O BEING HOT , FEELING "WEIRD" DENIED BREATHING DIFFICULTIES. EVALUATED BY EMTS, BP 180/120, HR 96, RR32 O2 SAT 100% ON RA. BP RETAKEN WITH MANUAL CUFF BY EMT REMAINED HIGH. PT. BP FOLLOWED FREQUENTLY OVER 30 MINUTES REMAINED ELEVATED TRANSPORTED TO ER BY AMBULANCE.
went to the doctor and said he has bell's palsy; started experiencing paralysis on the right side of his face; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Dec-2021 and was forwarded to Moderna on 01-Dec-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PARALYSIS (started experiencing paralysis on the right side of his face) and BELL'S PALSY (went to the doctor and said he has bell's palsy) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939905) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Nov-2021, the patient experienced FACIAL PARALYSIS (started experiencing paralysis on the right side of his face) (seriousness criterion medically significant). On an unknown date, the patient experienced BELL'S PALSY (went to the doctor and said he has bell's palsy) (seriousness criterion medically significant). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency and VALACICLOVIR for Adverse event, at an unspecified dose and frequency. At the time of the report, FACIAL PARALYSIS (started experiencing paralysis on the right side of his face) and BELL'S PALSY (went to the doctor and said he has bell's palsy) outcome was unknown.            No concomitant medications reported.  It was reported that patient started experiencing paralysis on the right side of his face, he went to the doctor and said he has bell's palsy. The doctor didn't say if it was related or not to the vaccine.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.  COMPANY COMMENT: This is a spontaneous case concerning a 30-year-old male patient with no significant clinical history who experienced the expected events of FACIAL PARALYSIS and BELL'S PALSY  The events occurred 31days after second dose of mRNA-1273 vaccine The rechallenge was not applicable since only information about second dose was disclosed  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: COMPANY COMMENT: This is a spontaneous case concerning a 30-year-old male patient with no significant clinical history who experienced the expected events of FACIAL PARALYSIS and BELL'S PALSY  The events occurred 31days after second dose of mRNA-1273 vaccine The rechallenge was not applicable since only information about second dose was disclosed  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Vasovagal and- patient blacked out at time of vaccine then middle finger on right hand (vaccinated arm) remained swollen x2 days; mild hives x 2 days on right hand - nausea and dizziness - on day of vaccination. mild dizziness day after
Reactivation of the herpes zoster virus manifested by the presentation of shingles.
Patient received 1st COVID vaccine on 3/21/21 per immunization information system - on 8/19/21 patient seen at primary care MD office with symptoms of COVID and tested positive
The flu was administered at a school site. The patient reported to the school nurse on 9/18/14 that he had severe pain in his right arm going into his shoulder and neck ever since the injection. The nurse reported this information to me on 9/19/14 and that she advised him to see his physician. I contacted him on 9/22/14. He had not seen a doctor but the pain was not improved.
Incorrect dose selected for patient.  Patient is 4 years old but Pfizer primary vaccine for 5 - 11 year old was selected and given to patient on 11/22/23 at 1:40PM.  Error identified the next day on 11/23/22.  Pharmacist called patient's father and informed him of the error.  Father reports patient is feeling typical side effects from the vaccine as follows: fever, chills, generally unwell feeling.  Pharmacist instructed father to administer Tylenol for children as needed, monitor symptoms, and to seek medical attention if symptoms do not improve or persists.  Pharmacist offered to call patient's pediatrician but father declined and stated he will call himself.
No additional adverse events reported; a patient was administered an improperly stored dose of PNEUMOVAX 23.; This spontaneous report was received from a nurse referring to a 70 years old patient of unknown gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.       On 02-DEC-2019, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # R030140, expiration date 07-AUG-2020; strength, dose, route, lot # and were not reported) for prophylaxis (product storage error). Temperature excursions were below 32 degrees Fahrenheit (27 degrees Fahrenheit) for 4 hours 3 minutes (1 cycle) and below 36 degrees Fahrenheit (32 degrees Fahrenheit) for 6 hours 13 minutes. There was no previous temperature excursion. Data logger was involved. No additional adverse events were reported.
pt recv vax 14APR98 @ approx 1130AM;pt was found dead 15APR98 approx 830AM;
Severe injection site pain starting about 2 hours after shot.  Headache starting about 3 hours after injection.
JOINT PAIN, BODY ITCHING, PATIENT WAS NOT ABLE TO MOVE HER HANDS.
Information has been received from a physician concerning a female patient who was vaccinated with a dose of GARDASIL. Subsequently the patient fainted. The patient's outcome was unknown. This is one of several reported received from the same source. Additional information has been requested.
Arm swollen, bruised.  Headache, achy all over, chills, nausea.
Patient went pale and fainted after receiving 3 IM injections and the Flu Mist.
reached a low temperature of Negative 1.3 C and were out of range for 9 hours and 48 minutes with no adverse event; FLUZONE QIV NP PFS was administered to patient post temperature excursion with no reported adverse event; Initial information received on 16-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2023SA057733(CLUSTER) and 2023SA057309(CLUSTER).  This case involves Adult patient of an unknown gender and reporter reported Influenza Quadrival A-B Vaccine [Fluzone Qiv] reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event.   It was unknown if the patient had any medical history, medical treatment (s), concomitant disease or risk factor.   On an unknown date, the reporter reported Influenza Quadrival A-B Vaccine Suspension for injection (lot number: UT7683NA, UT7682JA; Expiry date: 30-06-2023) reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event (product storage error) (latency: unknown)  (poor quality product administered) (latency: same day) (with an unknown strength, dose) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).   It was unknown if the patient experienced any additional symptoms/events   It was unknown if there were lab data/results available.   Action taken: not applicable.   Outcome:  Unknown for both the reported events   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.
I started feeling light headed at the time of receiving my first dose. I was not kept for the observation period and was released immediately . The next night i got home after a long day at work. I was brushing my teeth and on facetime with my boyfriend. One second I was there and talking the next I was on the floor and had urinated myself. I had experienced the first seizure i have ever had in my life.. I came around pretty quickly and called my mom. She then called my dr, who has been taking care of me since i was 3 years old, through the medical exchange. He contacted my mom very quickly and we were advised that it could have been me being tired or other factors. my mom then drove 3 hours to come take care of me and monitor me. I felt very heavy and lethargic, ,my head felt like it was on fire and my body felt like there was electricity pumping through my veins. I had to crawl to the door and unlock it for my mom while she was on the way. The next day went fine, I was alert and oriented x4. Exactly 24 hours after my first incident, I had another seizure. I was on a call with my friends and my webcam was on. My mom called ems and I was transported to the hospital. The ER Dr. who was on call spoke with me and immediately admitted me to run a whole course of tests. I had 2 EEG done, CT Scan, MRI, MRA, and bloodwork. They decided that I needed further testing and sent me to the hospital. I had a 48 hour monitored EEG done and they found abnormal activity.
On Jan 3 I had a pneumonia shot, vaccine 23. With in 3 hour I had trouble with pain in my legs, warming feeling. Shot was given in my left arm. Pain started in right arm, proceeded around to the top of my neck down my left arm. Pain was so bad that I could not have my blood pressure taken. Had diarrhea and Dr. put me on the BRAT diet. I was on this for 3 weeks and lost 10 lbs. right away. Finally pain subsided in three weeks and I was able to function pretty well still have a little numbness down my right arm. Still had problems with stomach. Dr. prescribed Famotidine. After taking one pill I was shaking with chills and the symptom of the shot returned. Soarness in left arm where shot was given and pain in the back of the neck. After a month I am pain free. However I am afraid to take any drug? The Dr say I am allergic to pneumovax and I should never have the shot again. Amen. How long will this drug remain in my body?
I had a drippy nose with post-nasal drip, a cough related to the post-nasal drip, and body chills. I took an at-home COVID-19 test on 12/05/2022 which came back positive; I contacted my doctor's office the next morning and was told to use the patient portal to input my symptoms and was prescribed PAXLOVID for treatment. I started the prescription that evening of 12/06/2022. The cold symptoms pretty much went away while on the prescription; I did still feel a little lethargic for a couple of weeks after, but overall I was fine. I still tested periodically which was still positive but I'm pretty much fine.
w/in 10 mins p/vax pt exp feeling of change & breathing faster & inc shallow; 15 mins post vax got cold sweats; 20 mins post vax back to RN & dizzy & clammy, face flushed, inj site red & diameter of baseball; monitored for next 30 mins;
On the 10th day, I developed a large itchy, warm, hard rash near the injection site. It spread minorly overnight and circled the injection site itself.
Pt. received KINRIX on (R) upper arm 2 days ago. Next day arm was red and swollen. Mom waited another day. Today his (R) upper arm is significantly larger than his (L) with a large area of redness, swelling and bruising encompassing most of his upper arm.
Heart attack; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 51-year-old patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDIAL INFARCTION (medically significant), outcome "unknown", described as "Heart attack".  Clinical course: This is first case out of two cases. Reporter Name: (Name withheld) (Name not clarified over the call, hence not captured in tab) Reporter stated, "May I ask you a question? I have two, have some friend, two of our friends, one was 51 the other one 72, post night after they had the COVID shot, one had a heart attack and the other one, she was told totally healthy, she run five miles a day, only walk five miles a day, never had nothing wrong with her, she died reactions from the COVID Shot(Pfizer was not checked as the manufacturer was not clear over the call). Now, I never had a COVID shot. Now, I might to get one but what (incomplete sentence). How do I know it's compatible because I take other kind of medication? I take shots every day. Every day I take Forteo. Somebody told me right plus I take other kind of medication. I take shots earlier shots every three months in my eye balls, then I take cholesterol pills. I take pills for the tummy and I take high cholesterol, no, cholesterol pills, 'Lisinopril' blood pressure medication and the one for the tummy (History). This W2022407365 is cross linked with W2022407370.   QR Comment: Reporter type could not be probed hence captured by default as Consumer or other non-health professional in tab.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient got covid vaccine on 10/4/22 on 10/6/22 noticed left deltoid red swollen and warm to the touch
Information has been received from a physician concerning a female pt who, post vax, experienced elevated liver enzymes, AST was 728 (normal 20-64) and ALT was 1860 (normal 12-47). Upon internal review, elevated liver enzymes has been determined to be an
COULD NOT SWALLOW HER FOOD DUE TO NAUSEA; COULD NOT BREATHE VERY WELL; NIGHT SWEATS; RIGHT ARM AND LEG BEGAN TO HURT; CHILLS; HEADACHE; TIREDNESS OR FATIGUE WAS UNGODLY; NAUSEA; VERTIGO-LIKE FEELING; PASSED OUT ON FLOOR; CHEST PAINS HERE-AND-THERE NOT CONSTANT; This spontaneous report received from a patient concerned a 64 year old white and non Hispanic or Latino female. The patient's height, and weight were not reported. The patient's concurrent conditions included colitis, non alcohol user, smoker (2 cigarettes per day), allergy to penicillin cause chest pains and swelling, allergy to sulfa cause chest pains and swelling, and medication sensitive. The patient had no drug abuse or illicit drug use. The patient experienced sick when treated with influenza vaccine (flu shot), chest pains and swelling when treated with codeine, and naproxen. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286 expiry: 23-JUL-2021) dose was not reported, 1 in total, administered at right arm on 13-MAY-2021 14:30 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient could not swallow food due to nausea and could not breathe very well (difficulty in breathing) and fatigue was ungodly. On 13-MAY-2021, the patient had tiredness, headache, nausea, night sweats and chills after took the vaccine. The right arm and right leg began to hurt. Tiredness was not gone away and Lightheadedness here-and-there. The patient had chest pains here-and-there, that was not constant. The patient felt like she had vertigo and passed out on her floor twice last week in MAY-2021 and on 04-JUN-2021. The Lightheadedness and dizziness presented again on 04-JUN-2021. A chill was come-and-go. The right arm and leg pain have resolved on 04-JUN-2021. She was not reached out to her primary care provider for medical advice. Patient mentions that she was medication sensitive. The patient had tendency for low blood pressure, but her low blood pressure was fine at 120/80 mmHg. The patient took Norco for pain and occasionally took Zofran for nausea. The patient had history of colitis and these medications help her. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from night sweats, and right arm and leg began to hurt on 04-JUN-2021, had not recovered from tiredness or fatigue was ungodly, chills, vertigo-like feeling, headache, chest pains here-and-there not constant, passed out on floor, and nausea, and the outcome of could not breathe very well and could not swallow her food due to nausea was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210612160-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Passed out. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY.
Mother of patient developed shingles (herpes zoster) one week after daughter (patient) received the live-virus varicella vaccine. Mother and patient live in same household.
Nosebleed; able to stop with holding pressure, lasted about 5 minutes; never had nose bleed in history but also experienced a nosebleed the day after his first dose as well
Facial swelling , went to urgent care and given steroids and recommended to not receive flu vaccine again
This non serious case was extracted from the VAERS database via QScan on 1 March 2009 (reference 295137). A 54-year-old female patient had received a second dose intramuscular injection FLUZONE SV 2007-2008, lot number U2514AA on 30 October 2007 at 20:30 hours and five hours later 01:30 hours, she developed a progressive headache, sniffles, a sore throat and burning of her eyes. At 06:45 hours, the sclera and conjunctiva of her eyes were very red and moist with mild eyelid edema. The patient denied any shortness of breath or rash. The patient's recovery status was not reported and no additional information was provided at the time of this report.
Erythema, swelling 12cmx20cm at injection site left anterior thigh within 24 hours of vaccine administration (DTaP0; fever. Follow up received on 11/26/03 states 11/14/03 per telephone f/u with reporter, diagnosis was confirmed as cellulitis. Treatment was with IV Ancef. The hospital discharge summary received on 3/3/04 confirms diagnosis of cellulitis. Also mentioned symptom of vomiting prior to hospitalization.
Patient fell suddenly ill after first (before second) injection and experienced severe abdominal pain, muscle cramps and other symptoms (on file at Medical Group).
Student say she felt dizzy c/o pain to both temples, c/o abdominal pain, c/o nausea feeling tired vaccine given at 10:50 AM at 3PM came to medical office B/P 108/69 T97.9 HR 84 regular, RR17, A+Ox3 no pallor pupils equal reactive to light.
Within a few hours post vax, the infant developed a fever of 103, which went as high as 103.4. The following day her temp was still 103.3. The infant was treated with Tylenol and the fever resolved in approximately 40 hours.
Having pain in left shoulder, same site where the Pfizer Covid Vaccination was given; hardly feel hand; its stiff; can hardly move her shoulder; she can feel it in the muscle; This is a spontaneous report from a contactable consumer (patient). An 84-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 31Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient reported she received the Pfizer Covid Vaccine on 31Mar2021. Patient was having pain in the left shoulder, same site where the vaccination was given. Patient could hardly feel her hand. Stated it goes and comes. 15Apr2021morning when patient woke up it was worse, it was stiff and patient could hardly move her shoulder. She could feel it in the muscle, since receiving the vaccination. Patient stated she needed help and was in pain. Patient asked what should be used for pain. Weight was 168 or 170, in between. Patient stated she wanted to call her doctor before it is too late. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Ringing in left ear. Now constant. Within hours after the first Pfizer vaccine (March 2021) I had new onset ringing in left ear. I did file a report at the time. Ringing continued and lessened. Due to ringing I delayed 2nd shot. Ringing intensified one week after second shot and is now constant and increasing. Never goes away and is much louder than after first shot.