chrisvoncsefalvay/vaers-outcomes huggingface dataset:
nose has been bleeding profusely, some blood when they blow their nose,blow their nose there is a small amount of blood; fatigue,tiredess; sore arm; mild headache,somewhat of a headache; a bit of chills; This spontaneous case was reported by a patient and describes the occurrence of EPISTAXIS (nose has been bleeding profusely, some blood when they blow their nose,blow their nose there is a small amount of blood), FATIGUE (fatigue,tiredess), PAIN IN EXTREMITY (sore arm), HEADACHE (mild headache,somewhat of a headache) and CHILLS (a bit of chills) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No medical history was provided by the reporter.  Concomitant products included LANSOPRAZOLE (PREVACID), VITAMINS NOS and PROBIOTICS NOS for an unknown indication.    On 20-Jul-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2022, the patient experienced FATIGUE (fatigue,tiredess), PAIN IN EXTREMITY (sore arm), HEADACHE (mild headache,somewhat of a headache) and CHILLS (a bit of chills). On 22-Jul-2022, the patient experienced EPISTAXIS (nose has been bleeding profusely, some blood when they blow their nose,blow their nose there is a small amount of blood). At the time of the report, EPISTAXIS (nose has been bleeding profusely, some blood when they blow their nose,blow their nose there is a small amount of blood), FATIGUE (fatigue,tiredess), PAIN IN EXTREMITY (sore arm), HEADACHE (mild headache,somewhat of a headache) and CHILLS (a bit of chills) outcome was unknown.            Patient received Moderna vaccine for all 4 doses she received. Patient did not have vaccination card available to provide details on those vaccinations.  The patient did not had fever, and, body aches,  No treatment medications was reported.
cough; low grade fever; feeling tired; This spontaneous case was reported by a nurse and describes the occurrence of COUGH (cough), PYREXIA (low grade fever) and FATIGUE (feeling tired) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced COUGH (cough), PYREXIA (low grade fever) and FATIGUE (feeling tired). At the time of the report, COUGH (cough), PYREXIA (low grade fever) and FATIGUE (feeling tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   She wanted to know if the vaccine will cause false positive for Covid-19 test.She's referring to the home antigen test, and wants to get her granddaughter tested.  Caller denied providing further details for Safety reporting, stating it's her privacy'. Denied consent for follow up, caller said she will follow up herself as she's a nurse.  23 Dec 2021
I felt lightheaded - dizzy only the day after vaccine. Didn't need treatment. I have a tinnitus condition.
Ipsilateral swelling (focal erythema, edema, warmth, and tenderness) distal to the injection site.
She presented with a firm nodule along her right peroorbital rim; Having a reaction; This spontaneous case was reported by a physician and describes the occurrence of INJECTION SITE REACTION (Having a reaction) and NODULE (She presented with a firm nodule along her right peroorbital rim) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product BOTULINUM TOXIN TYPE A HAEMAGGLUTININ COMPLEX (DYSPORT) injection for an unknown indication.    No Medical History information was reported.   On 05-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-May-2021, the patient started BOTULINUM TOXIN TYPE A HAEMAGGLUTININ COMPLEX (DYSPORT) (unknown route) 150 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, the patient experienced INJECTION SITE REACTION (Having a reaction). On an unknown date, the patient experienced NODULE (She presented with a firm nodule along her right peroorbital rim). The patient was treated with VORHYALURONIDASE ALFA (HYLENEX) for Adverse event, at a dose of UNK dosage form. At the time of the report, INJECTION SITE REACTION (Having a reaction) and NODULE (She presented with a firm nodule along her right peroorbital rim) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided. It was reported that patient had Dysport injected in her glabella, forehead, and crow's feet. The Dysport was reconstituted with 1.25 ml of bacteriostatic normal saline, was stored in a temperature controlled refrigerator before and after injection, and was used within one hour of dilution. The patient was not pre-medicated prior to the injection. Patient wanted to see the doctor. Patient had a nodule on the area where she had previously had filler. On an unknown date in Nov 2020, patient had Restylane Lyft, a full syringe, injected in the left temple. Restylane 0.2 cc was also injected in tear troughs on both sides in Nov 2020. In Oct 2020, patient had Versa 1.2 cc injected superficially via cannula in each temple. In Jan 2021, an unknown filler was injected in lower face by another provider, as reported to HCP by patient. HCP viewed it as a delayed inflammatory nodule, injected treatment and advised her to massage it. On 21 May 2021, HCP gave her a touch up of Dysport as well, as she needed a little touch up in her crow's feet and forehead.
Information has been received from a Licensed Practical Nurse referring to an unspecified number of unspecified patients of unknown age and gender. Concurrent conditions and medical history of the patients were not reported. On unknown dates the patients were vaccinated with doses of improperly stored PROQUAD (Merck) (lot # L030585, expiry date 10-FEB-2017) (dose and route unspecified), Other suspect and concomitant therapies were not reported, No adverse effects reported, Additional information has been requested,
On 7/20/09 received a T booster F and first Hepatitis B vaccine- 3 days later hot red itchy urticarial rash - this spread from torso out to limbs. No other suspicious cause.
Patient reports that he began feeling tightness in his throat just a couple of minutes after receiving vaccine. Reported symptoms to RN at 0936. During assessment, he reported an increase in severity of symptoms. Epinephrine administered & patient transferred to ED.
Patient experience localized reaction in left are which consisted of upper left arm swelling above the elbow with redness, warm to the touch, pain that limited range of motion. Patient advised to take TYLENOL and took BENADRYL on her own. Reaction resolved after 4-5 days.
Adverse events: Chills, fever, and swelling under left arm Outcome: all better after 24 hours
Pain, swelling/firmness, increase in temperature at site of injection, low-grade fever, sore/achy joints, and fatigue.
I was receiving Tdap on my 3rd trimester of pregnancy (EDD: 10/31/2018). Within 30 minutes I developed severe fatigue, followed by fever (101), tachycardia (HR 140-150's), myalgia, arthralgias, nausea, vomiting, pain on site of injection, bruising on site of injection, severe headache, body aches, lethargy, lack of appetite, and chills. I had to be hospitalized for 2 days.
This spontaneous report was received from a registered nurse regarding unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. Since 14-DEC-2015, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (dose and route were not reported, lot # L012038, expiration date 07-APR-2017). There was no adverse event reported. This is one of several reports received from the same source. Additional information has been requested.
Initial Report Received: 07-Aug-2018 and 08-Aug-2018. Patient is a 67-year-old man (race not provided) who was administered with HEPLISAV-B for hepatitis B immunization. The patient reported that he tested negative for hepatitis B surface antibodies after completing the HEPLISAV-B series. Relevant medical history included remission for mantle cell lymphoma. Concomitant medications included ASA, citalopram, flecainide, and CRESTOR. The patient received the first injection of HEPLISAV-B (Lot # 1033384, expiration 06-Apr-2019) on 18-Apr-2018. The patient received the second injection of HEPLISAV-B (same lot #/expiration as first dose) on 18-May-2018. Rituximab and bendamustine, administered for mantle cell lymphoma, were both stopped in Mar-2018. On 25-Jul-2018, 99 days after the first administration of HEPLISAV-B and 69 days after the second administration of HEPLISAV-B, the patient tested negative for hepatitis B surface antibodies. No other information was provided. At the time of the report, the outcome of the event was unknown. The reporter did not provide a seriousness assessment for the events. Company comment:  The company assessed the event of Hepatitis B surface antibody negative as non-serious. The event of Hepatitis B surface antibody negative is listed per HEPLISAV-B USPI. Sender's Comments: The company assessed the event of Hepatitis B surface antibody negative as non-serious. The event of Hepatitis B surface antibody negative is listed per HEPLISAV-B USPI.
Migraine headache on waking days 1, 2 and 3. Joint pain, nausea, lack of appetite, dizziness on day 2. Same symptoms to a lesser extent Day 3. Day 4 no symptoms.
64y/o FEMALE presents to the ED for evaluation of facial itching after COVD vaccine in left arm. The patient states shortly after the vaccine (about 10 minutes) her nose and mouth started itching. She was given PO Pepcid and IM Benadryl PTA in ED. She denies any associated SOB, nausea vomiting wheezes or near syncope. Denies fever/chills, n/v/d or other complaints at this time. IMPRESSION/PROBLEM LIST:---------------------1. Adverse Reaction to Vaccine for COVID
Pt had a headache and a pain in the arm until 6/18. She also developed a bandage shaped rash on the arm. It was red and itchy. (A latex free bandage was used to cover the injection site.) No more headache and pain in arm. However, the rash has not gone away (as of 6/20/18).
On Wednesday April 21, pain in right big toe. Severity of pain increased over next two days so that it was extremely difficult to walk and sleep at night. Toe was swollen.
Rash on left arm- a few centimeters from location of vaccine injection.   Rash is oval and large and itches. It is pink/red.
Dizziness starting the second night after the vaccine. Dizziness was worse at night for the first three nights. on the fourth day after the vaccine, dizziness persisted throughout the day and persists currently. Mild to medium dizziness resulting in mild nausea, light headedness, loss of balance when changing directions while walking, some stumbling.
Information has been received from a physician concerning a 16 year old female who on 10-JUL-2008 was vaccinated with the first 0.5 ml dose of GARDASIL vaccine (yeast) (lot no. 660389/1968U). On the same date the patient also received meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) and hepatitis A vaccine (inactive) (HAVRIX). After receiving the first dose the patient immediately became pale, lost her color and her arm felt numb at top of the arm. The patient was recovered after 15 minutes. The patient sought unspecified medical attention in office. This is one of two reports received from the same source. Additional information has been request.
Chills at 7 hours post vaccine; temp taken at 11 hours was 103; headache and nausea; terrible body aches; Worst symptoms resolved at 17 hours post vaccine; low level fatigue still at 48 hours post vaccine
This spontaneous report as received from a 29 year old female pharmacist who is also a patient. The patient's medical history and current condition was not reported. Approximately in 1997 (reported as at the beginning of 12 years of age) the patient was vaccinated with VARIVAX (Merck) (unknown strength, dose, frequency and lot number). Other concomitant medication includes prenatal vitamins (unspecified). It was reported that initially her titers showed immunity, titers drawn in JUNE-2014 or JULY-2014 showed no immunity to varicella. Lab test includes serological testing for immunity to VARIVAX (Merck). Cancer and overdose was not reported. The outcome of the event was unknown. Additional information has been requested.
sudden onset blurry and multiple vision both eyes; sudden onset blurry and multiple vision both eyes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 6 year-old male patient received bnt162b2 (BNT162B2), administration date 04Dec2021 16:00 (Lot number: FK5618) at the age of 6 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU taken for immunisation, administration date 22Nov2021. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FK5127, Vaccine Administration Time: 03:00 PM), administration date: 13Nov2021, when the patient was 6 years old, for COVID-19 immunization. The following information was reported: VISION BLURRED (non-serious), VISUAL IMPAIRMENT (non-serious) all with onset 06Dec2021 12:00, outcome "not recovered" and all described as "sudden onset blurry and multiple vision both eyes". The event "sudden onset blurry and multiple vision both eyes" and "sudden onset blurry and multiple vision both eyes" was evaluated at the physician office visit and emergency room visit. Therapeutic measures were not taken as a result of vision blurred, visual impairment.  Additional Information: Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination the patient not been tested for COVID-19. There were no known allergies.  No follow-up attempts are possible. No further information is expected.
Developed COVID-19 symptoms (fever, chills, cough and congestion). Used an at-home test July 17, 2022, which showed positive for COVID-19. I received the original two Moderna injections March 3 and 31, 2021; two booster Moderna injections October 30, 2021 and May 5, 2022. Contacted online doctor service following my positive test result, who prescribed Paxlovid. I completed the five-day regimen of pills. By the end of my five days of treatment, my symptoms abated.
Daily heart palpitations throughout the day. Chest pain/discomfort. Intermittent sharp pain near heart when inhaling deeply and diaphragm is fully expanded.
Pricking skin sensation; Itching; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Pricking skin sensation) and PRURITUS (Itching) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced PARAESTHESIA (Pricking skin sensation) and PRURITUS (Itching). At the time of the report, PARAESTHESIA (Pricking skin sensation) and PRURITUS (Itching) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was considered as not applicable. No treatment medication were provided. No concomitant medication were provided. .7 days ago patient had   itchiness .It's a prickly itchiness.
Vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported. revaccination offered.
Noticed Intense itchy scratchy far back of throat and feeling of lump (swelling) in laryngeal area Became very hoarse,Throat swelling and throat  itchiness lasted approx 20 to 30 mins then  gradually subsided. Hoarseness lasted approx  36 hoursOn Aug 16th 2021 intense itch all over body and at same time sudden diffuse wheezing and SOB but bc of psoriasis and other (unknown, not tested)allergies with same symptoms, can't be positive if related to Covid vaccine.
she developed hives; had slight swelling at the site of the injections; This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th February 2020, the patient received Shingrix. On 24th February 2020, less than a day after receiving Shingrix, the patient experienced injection site swelling and hives. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the injection site swelling and hives were recovered/resolved.   The reporter considered the injection site swelling and hives to be related to Shingrix.  Additional details were provide as follows: The patient picked up the vaccine from the pharmacy and took it to a clinic where it was administered so limited information was available. The patient had slight swelling at the site of the injections.  The evening of vaccination or the next day, the patient developed hives that seemed to have a pattern.   The patient took a dose of Benadryl and the hives went away.
MD saw pt on 28OCT93 & dx bacterial bronchitis, sinus infect & kidney infection which pt believes are the result of the flu vax; pt has had systemic lupus for over 25 hrs w/chronic systemic fungus infect;
Patients mother called office approximately after leaving clinic stating patient had broken out in a rash. Mother was instructed to bring patient back in for Dr. to evaluate. When patient arrived he was in no distress, brought to a room and Dr. looked at rash. Rash was an erythematous macular rash mostly on his face. We had patient and parents stay in clinic approximately 45 minutes to an hour. Patient was never in any distress, rash did not change at all. Dr. instructed parents to watch patient, if he became distressed call 911 or go to Emergency Room. 4/15/09 spoke with patients mom. She stated rash was almost gone, and patient was doing fine.
8 days after vaccination, i began to have hives over most of my body, starting 8:00am on 1/2/2021. On 1/3/2021, i went to a walk in and was prescribed prednisone which seemed to make it go away pretty quickly.
Really sore upper arm, could barely touch; red area, even around to front of upper arm; by evening: chills; at bedtime a bit over 100 degree fever.
pt stated that after he got the vax on 3/8/2021 his pulse went to 170 and BP went to 170/100.  He developed tremors, rash, and chest tightness. Vax clinic did an EKG w/ abnormal results.  Pt was transported to the Medical Center ER.  PT had Chest XRAY, 3 EKGs, and lab work.  Pt was released after 5 hours.  His DX was vaccine and biological substances causing adverse affects.  Pt was told to FU w/ PCP.
Information has been received from a pharmacist concerning herself who in May 2009, was vaccinated with 0.5 ml of the first dose of GARDASIL IM, in July 2009 received 0.5 ml of the second dose of GARDASIL IM, and in December 2009 0.5 ml of the third dose of GARDASIL IM. Concomitant therapy included NUVARING. Three days after the third dose she had a PAP test and biopsy. The results show mild dysplasia of CIN1 and an aggressive type of HPV. No treatment at this time. The patient sought unspecified medical attention. Additional information has been requested.
Large, 6cm diameter, red - blistered area. Warm to touch, tender. Tender lymph left axilla. Prescribed Cephalexin 250mg 15ml x 10 days.
Subsequently, after each dose, the pt developed injection site soreness and swelling. It was noted that the pt subsequently received a dose of hepatitis B vax and developed a red, raised rash as well as blistery areas.
A report has been received from a health professional concerning a 21 year old, female subject, who had been receiving nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT STARTED ON 14-Jan-2014. The patient was administered expired FLUMIST QUADRIVALENT (preferred term: expired drug administered) on 14-Jan-2014. The outcome of the event of expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
Within 24 hours of receiving the 1st vaccine shot my menstrual cycle started 17 days after my last period.  This is 10 days early and is not normal for me.; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 22Mar2021 at 15:30 (at the age of 40-years-old) as a single dose for COVID-19 immunization. Medical history included paraguard (intra uterine device) IUD (no hormones). Concomitant medications included multivitamins (MANUFACTURER UNKNOWN) and fish oil vitamin (MANUFACTURER UNKNOWN). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Mar2021, the patient had nasal swab test (Roche Rapid Antigen Test) and resulted negative. On 23Mar2021 at 16:30, the patient experienced abnormal menstruation within 24 hours of the first dose of vaccine. It was reported that, menstruation was 10 days early and this was not normal for the patient. Her menstrual cycle started 17 days after my last period. From the last 7 years the patient tracked the cycle and it was always 4 weeks apart. The patient had not experienced any recent weight loss or gain. The patient stress level was not any higher than it was over the last year. The patients mother did not go through menopause until her mid 50's. The patient was a healthy active adult. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No treatment received for the event. The clinical outcome of event abnormal menstruation was resolving at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information expected.
Temperature Excursion. Vaccine was stored refrigerated (2-8 degrees Celsius) for greater than 10 weeks.  Vaccine was stored for a total of 7 days past its beyond use date in the refrigerator.  Patient did not experience any adverse events.
Pt's boyfriend reported that Pt was feeling like passing out. Noted pt. Pale assisted to the floor carpet, with out patient losing consciousness. No SOB, no pain. No evidence of allergic or anaphylactic reaction to the immunization. VS taken, per pt she has Hx of low BP's. PT reports that she usually gets anxious and has panic attacks when  she has Immunizations or blood drawn. States has similar reaction because she is afraid and gets nervous. States she had little to eat and earlier had a test. VS taken and recorded. Pt taken to IM and report was given to Dr. A TAV was booked at 4:55 PM. Pt stable VS stable. Pt was picked up by boyfriend and mother and taken home, she left stable steady gait at 5:05 PM.
About 10 days after recieving the flu vaccine I noticed pain, numbness, and superficial burning sensation along the lateral side of my left arm extending to the small finger.  These symptoms continued for about 1.5 months.  I tool ibuprofen 400 mg about every 12-24 hours to control symptoms.  These symptoms have subsided.  I now have persistent weakness in my left arm and mild soreness along the outaspect of my left lower from below the deltoid to my midforearm.
Pain at injection site; egg shape & size hard lump at site; redness at site; lump hurts with pressure
After initial side effects resolved, new swelling, warmth to the touch in comparison to other arm, and redness at injection site.