chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After quite a painful injection on my upper L shoulder (I felt the needle quite sharply from the moment it went in, to the moment it came out, which seemed like a few minutes rather than seconds), I initially lived with a bruised upper arm/shoulder for about 3 weeks.  During this time, colors ranging from purple to red to yellow were all visible in the vaccinated area, accompanied by pain and itching.   The more long-term effect of the injection started, however, after this three-week period when it became clear that this was an incorrectly administered vaccine (SIRVA) due to the constant "crawling" and "electric-like sensations" felt on my left upper-back, lasting to this day!   Having shared these symptoms with my PCP, I was advised to follow up with a neurologist (whom I will be seeing soon).  In the meantime, I wanted to report my case in order to present a clear picture of what has happened to an area of my body during the past 7+ months, which was perfectly healthy before I received my second COVID-19 vaccine.  I am not sure if these symptoms will disappear any time soon ? or ever go away ? but I am hoping that the Hospital will take some form of responsibility when it comes to the training of its medical professionals (and perhaps consider administering its vaccines not anonymously but with an identification of the vaccinator attached to the patient?s record).
About  20 hours after booster  patient describes tightness in chest, SOB, and then palpitations. Then went to ER. Was examined /observed in ER then released.
Information has been received from a nurse concerning an 81 year old female who on an unknown date, was vaccinated with PNEUMOVAX (lot# not provided). Concomitant therapy included Influenza virus vaccine (unspecified). Subsequently the patient experienced a swollen red, feverish arm which was diagnosed as cellulitis. The patient was advised to use warm compresses, TYLENOL and BENADRYL. At the 2 week follow up, the symptoms had resolved. Unspecified medical attention was sought. This is one of several reports from the same source. Additional information has been requested.
This spontaneous report as received from a nurse refers to an 15 years old male patient (unknown gender). No concurrent condition, medical history or allergy/drug reactions were reported. On 31-MAR-2015, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) GARDASIL injection, dose number 1, lot #K004204, exp. date: 12-JAN-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Flu-like symptoms- tired, weak, pain throughout body, fever (99-102 F) which lasted from the morning after the immunization until approx. the next day.
A few minutes after receiving the vaccine PT sat down, stated that she didn't feel well, and fainted falling forward from the chair to the floor. She hit her head on the floor (right eyebrow). She was conscious immediately after the fall when I responded. There were no other symptoms or injuries. She applied ice to her eyebrow, and we gave her water. We called 911 immediately and they talked with her about the incident. She did not leave with them. They recommended someone come pick her up.
Information has been received from a female nurse practitioner consumer through the pregnancy registry who on unspecified dates was vaccinated with the first and second doses of Gardasil (0.5 ml). Subsequently the patient reported that she had recently became pregnant. The patient also reported that she experiences burning, pain, and nerve tingling in her arm "soon after" receiving the second dose of Gardasil. The patient reported that she had a similar experience to a lesser degree following the first vaccination with Gardasil. It was though that the pregnancy occurred after the above events. Unspecified medical attention was sought. The patient subsequently recovered from the burning, pain, and nerve tingling in her arm "a short time after each injection." Additional information has been requested. This is in follow-up to report (s) previously submitted on 3/14/2007. In follow-up, the nurse practitioner reported that she was not vaccinated within the timeframe to be in the pregnancy registry. She received her second done at the end of October 2006 and did not get pregnant until the end of Januray 2007. Her baby was 8 months old at the time of this report and was doing "just great". Additional information has been requested.
recieved first dose in APR-2021; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (recieved first dose in APR-2021) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (recieved first dose in APR-2021). At the time of the report, PRODUCT DOSE OMISSION ISSUE (recieved first dose in APR-2021) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.    Concomitant product use was not provided by the reporter.   No treatment information was provided.
On 8/16/2021, the patient received Janssen covid-19 vaccination and was advised to wait for 15 minutes. Patient stood up around 4 minutes after vaccination & informed pharmacist that he was having a panic attack. Pharmacist went to assist patient & caught him as he fainted. Pharmacist technician called 9-1-1 immediately & they arrived within 10 minutes of the phone call. The patient was awake & conscious when they arrived & declined EMS care. The patient walked out & left with his girlfriend around approximately 2:35 pm.
ABOUT 6 DAYS AFTER RECEIVING MY COVID19 VACCINATION. I STARTED TO DEVELOPED MOUTH BLISTERS OR COLD SORES. THEY WOULD GO AWAY AND RETURN DAYS LATER ON OTHER PART OF THE MOUTH. THIS HAPPENED ABOUT 3 TIMES AND THE LAST TIME WAS ON TUESDAY 1/19/21 WHERE I DEVELOPED A HUGE PAINFUL LUMP UNDER MY JAW BY THE EVENING. I DON'T USUALLY SUFFER FROM MOUTH BLISTERS. I HAVE ONLY DEVELOPED THEM 3 TO 5 TIMES IN MY ENTIRE LIFETIME. I MADE AN APPOINTMENT WITH MY PRIMARY DOCTOR, WHO CONFIRMED THAT THE LUMP WAS A SWOLLEN LYMPH NODE, IT WAS HUGE, THE SIZE OF A GOLF BALL. SHE DID A PHYSICAL ON ME TO CHECK IF I WAS SICK AND HAD NO OTHER SYMPTOMS ASIDE FROM THE MOUTH BLISTERS AND THE HUGE LYMPH NODE.
Inappropriate age at vaccine administration with no reported adverse event; Initial information received on 14-Nov-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 12 years old male patient who was administration Influenza Quadrivalent Recombinant Vaccine [Flublok] vaccine at inappropriate age.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 12-Nov-2022, the patient received a dose of 0.5 ml dose 1 of suspect Influenza Quadrivalent Recombinant Vaccine (lot UJ888AA) via intramuscular route in the right deltoid (formulation, expiry date, strength was unknown) for immunization that was administration at inappropriate age with no reported adverse event.  Action taken was not applicable.  Outcome: unknown  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.
Given PREVNAR 13 right anterolateral thigh 5/19/10 had URI symptoms that day, no fever. Next day (5/20/10) tactile low-grade fever, cranky in evening lacey rash and swelling R anteromedial thigh with fever 103.3; 5/21/10 am T 102.8 office visit, thigh swell decrease. Right AOM lacey flat pink rash not warm below vaccine injection site T 103.5. Not tender not warm not swollen.
This case was reported by a physician via call center representative and described the occurrence of back pain in a 64-year-old female patient who received SHINGRIX (batch number LT533, expiry date 11th October 2020) for prophylaxis. Previously administered products included ZOSTAVAX (received in 2014). Concurrent medical conditions included atrial fibrillation. Concomitant products included CARDIZEM, flecainide, LIPITOR and XARELTO. On 8th June 2018, the patient received the 1st dose of SHINGRIX. On 8th June 2018, immediately after receiving SHINGRIX, the patient experienced back pain and fever. On 13th June 2018, the outcome of the back pain and fever were recovered/resolved. It was unknown if the reporter considered the back pain and fever to be related to SHINGRIX. Additional details were provided as follows: The patient experienced pain across top of back and fever, both events began immediately and resolved in 4 to 5 days. The fever has resolved without sequelae. The patient experienced the adverse event after 2nd dose for tolerance see linked case US2018GSK181164.
34-year-old female with possible allergic reaction to Johnson & Johnson Covid vaccine, seen by Dr. and treated with Benadryl, epinephrine, upset and Solu-Medrol.  She had evaluation emergency department consisting of Covid screen which was negative.  Care transferred to me at change of shift awaiting ongoing observation.   On reevaluation she is resting comfortably and dozing.  She and her mother report history of frequent reactions to multiple medications and foods.  She had a similar reaction to first dose of Pfizer vaccine.  She recently was evaluated by an allergist for reactions to multiple fruits and told that she has Ehlers-Danlos syndrome.    She describes her symptoms today as mucus in her throat, seeing flashing lights and then blacking out.  She denies itching or rash.  She had associated dyspnea.   Feels much improved currently with no further sensation of throat difficulties or dyspnea.  She is noted to have continued tachycardia of uncertain etiology.  Vital signs otherwise unremarkable.  SPO2 is 97% on room air.  She is normotensive.   She had additional liter of normal saline administered and ultimately improvement of heart rate to approximately 105.  She is resting quite comfortably and there approximately 8 hours on reevaluation reports feeling back to normal with no dyspnea or sensation of mucus in her throat.  Thinks that she will be able to rest at home.   In light of her efforts to obtain effective Covid vaccination as well as good symptom relief currently it is thought that deferral of additional steroid medication is indicated.  This is discussed with her and her mother who are in agreement.  Further treatment and indications for ED return are reviewed.  Good understanding.
This spontaneous case, initially received from a pharmacist on 24-Sep-2018, concerning an 80-year-old, elderly patient of an unspecified gender. The patient's medical history and concomitant medications were not available. Since 03-Sep-2018, the refrigerator's temperature fluctuated above 47F and FLUAD (TIV) vaccine exposed to temperatures in the range of 47F to 50.9F. On 12-Sep-2018, the patient was administered FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number and expiry date: not reported) which underwent temperature excursion. The patient did not experience any adverse drug reaction after the vaccination. The reporter assessed this case as non-serious. This case 201804092 cross-linked to original case 201804076 due to the same reporter. Non-significant follow-up received from the reporter on 14-Nov-2018: Added Med info number (SEQ18-04086) in the additional information tab. No changes were made in the narrative.
fever, aches, flu like sx by 8PM 27JUL93; began Advil q 4 hrs sx cont 28JUL93 & 29JUL93 came to clinic report sx; advised to call MD 30JUL893;
fever, chills, joint pain, nausea, headache, overall pain, insomnia
Occulo-respiratory-eyes-sclera very infected sore throat, chills, cough - eyelids with edema- onset 3-4 hours s/p FLUZONE inj.
Approximately 30 seconds after vaccine administration the patient's arm bruised (11 inch diameter) and swelled (1/2 inch raised). The patient did experience any other symptoms. Approximately 4 hours later the patient returned and some swelling had gone down and stated it was sore at the injection site but no other problems.
I had swelling and a rash on the left side of my face. I also had loss of hearing in my left ear and bleeding in my ear. I am having tingling and burning on the left side of my face. I contacted my doctor and was diagnosed with Shingles and was prescribed VALTREX. I was also prescribed some ear drops due to the bleeding in my ear that had an antibiotic and steroid in it. They thought I had Cellulitis at first and I was prescribed AUGMENTIN. I am still dealing with this at this time.
I had no previous health issues in general before my vaccinations. At about 15 min, my vision began to get blurred. It was like there were bright lights in front of me. After a bit it did go away, and that was after the first dose. After the second dose no symptoms until in August my vision changed, I went to an eye doctor, the doctor stated that my left eye seemed to show signs of diabetes. I then found out that I had a detached retina. My concern is that they began to give injections to treat the symptoms, and I am starting to see squiggly lines in my vision and some of my vision seems to be getting cut off. Symptoms are getting worse and there is no diagnosis other than the detached retina. My face is getting numb on one side of my body and tests have ruled out any signs of a stroke. Now I am beginning to have pain in my left eye.
Left arm sore immediately; difficulty moving/raising left arm"frozen shoulder" 2-3hours. Later patient reported this 11/22/02. Given Naprosyn 500mg BID for 3 days. Reports almost complete improvement
she had significant pain later in the day of vaccination and was unable to lift her arm for a week, she continued to have pain in this arm/shoulder for a couple more weeks
Lightheaded and dizzy for 24 hours after shot. Entire left arm in pain 24 hours after shot, as well as migraine headache and debilitating body aches. 48 hours after shot felt fatigue and brain fog. Then from 03/29 to 04/01 felt inflammation in rib cage that made it hard hard breathe and move. The last part was very similar to "Covid Relapses" I have had since getting sick in March 2020.
Breakthrough case of COVID-19 after fully vaccinated with 3 doses of mRNA vaccine.
blood pressure was high; mild stroke; transient global amnesia; sore arm; A spontaneous report was received from a consumer concerning a female patient of unknown age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced mild stroke/cerebrovascular accident, transient global amnesia, sore arm and high blood pressure.  The patient's medical history was unknown. Concomitant product use was not provided by the reporter.   On 02 Mar 2021, prior to the onset of event, the patient received their second of two planned dose of mRNA-1273 (Lot number: 010A21A) vaccine in the left arm for prophylaxis of COVID-19 infection.  On the same day as the second dose, the patient experienced a sore arm later in the day.  On 21 Mar 2021, she had mild stroke. It shocked her because she did not have medical issues that would have lead to a stroke. She did not immediately go to hospital. She followed up with her doctor who then asked her to go to the urgent care or emergency room (ER). She went to the urgent care first and they said she needed to go to the ER because of the symptoms she was having. She then went to the ER. She was there for 6 hours. She asked the nurse if they were going to admit her but nurse said no because she was not having the symptoms at that time. In the ER, she had an MRI, CAT scan, EKG, chest x-ray done and also had blood drawn.  The patient had high blood pressure noted while in the ER.  The ER doctor said she had transient global amnesia which they said was precursor to the stroke. The event was also considered to be medically significant. Treatment information was not provided.   Action taken with the mRNA-1273 in response to the event was not applicable.  The outcome of the events, mild stroke, transient global amnesia, sore arm and high blood pressure, was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
After the first Vaccine Patient started having Migraines. Migraines lasted for about 2 months. Patient stated that a few days after receiving the vaccine she lost her vision. she was disoriented and weak.
CAR ACCIDENT; WHIPLASH INJURY; CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; HEADACHE; This spontaneous report received from a patient concerned a 76-year-old  female. The patient's height, and weight were not reported. The patient's past medical history included measles, and chicken pox. On 20-MAR-2021, the patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805029, and expiry: UNKNOWN) dose was not reported, frequency 1 total, administered on left deltoid for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, the patient experienced headache on the day of vaccination. Treatment medications included: paracetamol. The reporter stated she was involved in car accident after 1-2 month of vaccination. The patient mentioned she received stem cell injections to treat whip lash injury following accident. On an unspecified date the patient reported that she had Covid-19 antibody test drawn by her primary care physician which came negative. On 24-JUN-2021, the patient had another lab test COVID IGG test, and the results came negative on 25-Jun-2021(confirmed immunological vaccine failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 21-MAR-2021, and the outcome of confirmed immunological vaccine failure, car accident and whiplash injury was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210660662- covid-19 vaccine ad26.cov2.s - Confirmed Immunological failure. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are no other factors more likely to be associated with the event(s) than the drug.
Arm started out sore immediately after the administration was completed. The arm has become more sore each day with ROM now limited with increased pain when lifted away from the body or up in the air. Opening the car door and applying a seatbelt is painful. Tingling and slight numbness began 10/25/18. Hot pack provided little relief. Ibuprofen helps with pain but not ROM. Point of admin remains tender but is not red or ecchymotic.
Case number PHEH2013US017916, is an initial spontaneous report received from a pharmacist on 20 Aug 2013. This report refers to a 19 year old female patient. Past medical history and concomitant medication was not reported. She was vaccinated with expired MENVEO (batch numbers: A10133 and expiry date: Feb 2013) intramuscularly on 20 Aug 2013. No adverse event was reported following this administration error.
Patient had softball size red swollen reaction at site of injection with quarter size darker red hard kast at site. KEFLEX 500 mg TID x 7 days. Arthus reaction.
At around 11pm I had the chills, I was shaking pretty bad, no fever and I had a major headache. I do not have any access to tylenol and I will wait to take some when I arrive home at 7am. Its about 530am and I still have a headache. I've been drinking lots of water and I feel nauseous now.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Apr2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 66 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypothyroidism" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing). Concomitant medication(s) included: ESTRADIOL; PROGESTERON; THYROID. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid.
facial/mouth tingling, dizziness, sensation of heat and flushing, shakiness, rapid heart rate (103), increased BP (153/94) rapid breathing, slight difficulty breathing. approx 50 minutes later bp still elevated (163/99) pulse 99, still with some facial/mouth "tingling", slight dizziness, breathing reported as "better". Took ativan at 2:40 and claritin at 3:00 pm. 4:30 pt symptoms just about resolved.
approx 3yrs p/ vax pt devel chickenpox w/lesions too numerous to count over top part of body.
Overnight developed a large red, hard area.  Mother is reporting as of 10/10/2023 there is still a large red area at the site of injection.
Administered by error a Shingrix adjuvant portion only; Administered by error a Shingrix adjuvant portion only; This case was reported by a physician via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.       Additional Information: GSK Receipt Date: 18-JAN-2023 Reporter's Comment: The reporter was a medical assistant reported on behalf of the physician. The reporter reported that they were administered Shingrix adjuvant portion only by error to the patient. The healthcare professional was disconnected the call and no other information was possible to obtain. Although agent was called several times to the phone number provided and finally, a front desk assistant confirmed that the physician had already received medical information on this scenario. The reporter did consent to follow up. Additional supportive information: The reporter gave by error only adjuvant of shingrix administered to patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
On the night of 2/21/2023, I began getting a scratchy throat and cough. On 2/22/2023, I had what seemed like a cold. I took a home antigen test and got a positive result. On 2/22/2023, I had a fever of 101, which lasted one day. I began taking PAXLOVID on 2/24/2023 or 2/25/2023. The symptoms went away pretty quickly, and I tested negative after about seven days. At the time of this writing, I feel great and feel that I have made a full recovery.