chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AEs were reported; Received GARDASIL 9 in alternate dosing schedule; This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. The patients' medical history, concurrent conditions, and concomitant medications were not reported.   On 18-JAN-2021 and 30-JUL-2021, the patient was vaccinated with the first and second doses, respectively, of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, as prophylaxis (routes of administration and injection anatomical locations were not reported). On 20-MAY-2023, the patient was vaccinated with the third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, as prophylaxis (route of administration and injection anatomical location were not reported) (lot numbers 1687290, T028583, W001498 [the specific dates of administration of each were unknown] were verified to be valid, expiration dates reported and confirmed as 06-SEP-2022, 04-MAR-2023, and 15-SEP-2024, respectively). It was stated that the patient received HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) in alternate dosing schedule (Inappropriate schedule of product administration). No additional adverse events or product quality complaints were reported.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. No patient's concurrent conditions, medical history or concomitant medications were reported. On 17-NOV-2015, the patient was vaccinated with ZOSTAVAX subcutaneous injection, Lot# L031274, expiry date 19-NOV-2016 (strength, dose, injection site were not reported). The patient had an immediate reaction once the vaccine was being administered. The patient developed an immediate "red rise" in her skin at the site of injection. The pharmacist stated that she stopped the administration of the ZOSTAVAX as a result of the immediate reaction to the vaccine upon administration. The patient had a red raised welt at injection site. Consequently, the patient was not administered the full dose of the ZOSTAVAX. There were no labs tests performed and no treatment given for the adverse event. It was reported that the patient had not recovered from the adverse events. The causality between the events and suspect drug was considered to be related. Additional information has been requested.
Estimated delivery Nov. 10, 2021. Intrauterine fetal death was diagnosed August 13, stillbirth delivered August 14th. As of now there is no known cause despite the tests that have been run.
Patient received the shot with no problems. Called on 10/28/2020 around 5pm and reported that she was hearing "sprinklers" in her ears. She said it had started that same day around noon but there are no sprinklers on in the area. She asked if this could be from the shot. I researched and found that ringing in the ear could come from the shot. She said that she wasn't worried about it. I informed her she may need to see her doctor if it did not go away but she said she was unconcerned and would still be getting a second shot. She said that she was sure it would go away and I again advised her to seek medical attention if it had not especially as we head into the weekend.  She said she was not concerned, she has had shingles in the past (age 19) and will not get them again she is going to continue with the vaccines just wanted to know if it was the vaccine or something else. I told her I couldn't be sure but it is possible.
Patient complains of Left arm pain since the day she received the Hep A vaccine. She stated the nurse told her the needle broke in her arm and then repeated the test in the same location.
Reports 11/12 with fever to 103.5 resolved 24 hours. On 11/15 woke with chest pain, evaluation at hospital with ECG mild ST elevations, elevated troponin. Probable vaccine associate myopericarditis.
On January 29,2021 at about 9 am I experienced extreme total body weakness as though I was about to faint. I managed to lie down. Concurrent with the extreme weakness I felt intense nausea. The weakness and nausea lasted for approximately 45 minutes to one hour when I had to rush to the toilet for a bowel movement. Within an hour to an hour and one half I was totally asymptomatic. There was no recurrence of the GI symptoms or exteme weakness. At the same time I felt itching at the site of the Covid 19 vaccination. When the GI symptoms and weaknes subdided and I looked at my upper left arm, there was swelling and redness surrounding the vaccination site and around the side of my left arm. The itching, swelling and redness lasted for 24 hours and began to subsdide until it was only faintly recognizable as a light pink discoloration around the original vaccination site. Today, February 6th, 2021 the redness has almost completely faded.
Syncope, hypotension, seizure-like activity within seconds after administration. Resolved and patient returned to her baseline and vital signs stable.
Redness swelling and heat at injection site ~48 hours post injection still ongoing  Dizzy, brain fog ~1.5 hours post and continue for 48 hours Severe headache ~2 hours post and continued 36 hours  Fatigue~ 6 hours post and continued for 15 hours Extreme joint pain and muscle aches ~10 hours post for 46 hours Fever, chills, nausea ~12 hours post with 100 for 8 hours, 101 for 12 hours and 102 for 24 hours breaking on day 2  Stomach cramps and diarrhea ~14 hours post and ending after 48 hours
I had a sore arm initially and then on Wednesday I felt really tired in the morning. My heart started pounding at around 7 or 8pm and heart rate was 100 which is abnormal for me. It stopped after I spoke with the provider but started again that night and has been ongoing since. I started having pain in my chest and the palpitations are off and on. Heart rate when at rest is usually mid 70's but its been remaining in the 80's and then last night. my heart rate dropped to the 60's.
This spontaneous report was received from a female patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. In 2007, the patient was vaccinated with ZOSTAVAX (dose, route of administration, anatomical location, lot # and expiration date were not provided). Information regarding diluent was not provided. On an unknown date in April 2017, the patient developed shingles after receiving ZOSTAVAX. The outcome of the event and the causality assessment were not provided. No product quality complaint was involved. Additional information is not expected as the reporter declined to participate in answering questions within the adverse event.
Pain that began in back two days after getting vaccine.  Began to get worse and then also began to hurt under breast bone.  Doesn't go away.  Worse at night and in the mornings especially while sleeping.
The day after my second vaccine shot (it was a Saturday) I experienced a sore neck where it was becoming difficult for me to turn my head to either side.  By the next day (Sunday) I had SEVERE Occipital Neuralgia:  extreme pain at the slightest movement of my neck as well as pain just laying still and not moving - the neck pain was severe and it was radiating in a lightning fashion up the back of my skull.  The next pain was specific to the top of the neck at the base of the skull.  It was not a pulled muscle radiating down into my shoulders.  It was right at the base of the skull.  By the 3rd day (Monday) I was still in pain and it hurt to even touch my scalp it was so sensitive.  At the base of my hairline, the skin had a blotchy light red appearance throughout my hair.  While the intense pain only lasted the 3 days I am still experiencing soreness in my neck even to now 6/30/2021 and I have difficulty turning my head to either side.  It is not getting better at all.  Sometimes I even feel the nerves coming up to the base of my jaw, and, possibly that my neck lymph nodes are sore.
Child received MENVEO vaccine on 7/27/11 & started having large local reaction around the site. Area is red, indurated, & pruritic. Total diameter is about 15-18cm. Patient given steroid & told to use cold compresses & BENADRYL.
Immediately after the 2 vaccines were given, patient complained of not feeling good.  Pallor and sweating noted; also complaints of nausea- then vomiting, "lightheaded".  Symptoms resolved after 5 minutes.
Patient received injection and 5-10 minutes experience syncope as well as pain radiating in arm.  Patient recovered from syncope but still experiencing pain in arm
Weird feeling in armpit of injected arm; Inflammation of joints; Over all body ache; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY PAIN (Weird feeling in armpit of injected arm), ARTHRITIS (Inflammation of joints) and PAIN (Over all body ache) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Sulfonamide allergy and Allergy to antibiotic.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced AXILLARY PAIN (Weird feeling in armpit of injected arm), ARTHRITIS (Inflammation of joints) and PAIN (Over all body ache). On 07-Apr-2021, AXILLARY PAIN (Weird feeling in armpit of injected arm) had resolved. At the time of the report, ARTHRITIS (Inflammation of joints) and PAIN (Over all body ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication: Antihyperlipidemic medication.  No treatment provided.
PATIENT REPORTED "REALLY BAD" HIVES THE NIGHT OF VACCINATION.  THEN OVER THE NEXT COUPLE DAYS SHE DEVELOPED MULTIPLE BLISTERS ON HER TOE, LIP AND HEELS.  CURRENTLY STILL HAVING THESE SIDE EFFECTS, AND WILL SELF TREAT AT HOME FOR NOW.
At 20 hours after vaccine, experienced chills, extreme fatigue, headache, fever fluctuations between 97.1 and 104.3 degrees for about 24 hours
Fatigue, headache, chills, fever to 99.9 for 24 hours
tested positive with Covid-19/ he has recovered from the infection and he has no symptoms already; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a male patient of unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (manufacturer: Pfizer) on 12Mar2021 at single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included tetanus vaccine toxoid (TETANUS ADS IMPFSTOFF) on 20Mar2021, measles vaccine, mumps vaccine, rubella vaccine (MMR VACCIN) on 20Mar2021. Patient is due for the second dose of the vaccine tomorrow, 02Apr2021. However, on 22Mar2021, he has tested positive for COVID-19. He said that more or less he has recovered from the infection and he has no symptoms already. He wanted to know if he should be taking it tomorrow or not. Patient also mentioned that on 20Mar2021 he had 2 other vaccines, tetanus and MMR vaccines. Patient asked if they would interfere with bnt162b2. The outcome of the event was recovered. Event was considered serious as medically significant.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the temporal relationship, the association between the event COVID-19 with BNT162b2 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
I had chills; my temperature is 100.7/ fever; Joint pain; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 04Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "I had chills"; PYREXIA (non-serious), outcome "unknown", described as "my temperature is 100.7/ fever"; ARTHRALGIA (non-serious), outcome "unknown", described as "Joint pain". Relevant laboratory tests and procedures are available in the appropriate section.  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.
My cheeks and upper lip became swollen hours after having the vaccine. I had no other signs of an allergic reaction. In the past, I have had similar, but more severe, facial swelling that from antibiotics containing sulfonamide and fenugreek tea that also did not progress past facial swelling. I took Benadryl (two capsules). The swelling did not progress. They did have me wait 30 minutes after receiving the vaccine due to my history of allergic reactions to other things and nothing occurred during that time frame.  My cheeks and lip are still  very slightly swollen and I plan to take a second dose of Benadryl to make sure it completely dissipates.
Chills Body aches Fatigue  Pain in right arm  Headache  Started around 12:30pm on February 4,2021 until  Resolved morning of February 6, 2021
I had headaches ever day. They didn?t go away with Motrin. After I realized I had headaches every day for a month I called my Dr. They said go to the ER. The IV treatment at the ER gave me relief for one day then the headaches came back. My Dr tried Prozac in case it was stress and anxiety, but after two weeks I had an allergic reaction and the headaches weren?t helped. Then I went to a neurologist. I had daily migraine non-stop for 4 months before I started finding relief. My life has been completely changed. The pain was so terrible. Now I am on a lot of daily medicine and a monthly shot which looks promising but I haven?t been in it long enough yet.  I lose a day of work occasionally.  My triggers are many and instant. This is nothing like the two migraines and some headaches a year I used to have that didn?t affect my daily life so much.
Onset of daily headaches/migraine/neck; extreme pain in center of back/spinal cord; extreme tightness in band around ribcage; tightness in abdominal muscle and muscle of ribcage; pain in lower spine and into legs/feet -include burning weakness and numbness. Extreme fatigue. After Medrol 2X, inflammatory pain subsided. Muscles left weak - difficult to maintain correct posture. Scoliosis in parts of spine worsened. Continuing to treat with massage, ice, physical therapy, muscle relaxers, pain meds and aspirin. Fatigue continues.
I began experiencing fatigue / ? body heaviness and sleepiness? about an hr after vaccination . I developed a migraine headache and ? leg cramps and aching ? about 6 hours after the vaccine which lasted about 8 hours . It took about 24 hrs for the fatigue to get better .  I took ibuprofen and Tylenol for the leg cramps and headache , but the leg cramps were not relieved by this.
Bilateral eye swelling. Difficulty breathing through nose. BENADRYL at 2:40 pm (5mL PO).
About two or three days after receiving the shot, i developed an itchy rash on both my hands and also had patches on my lower back.  I am not sure if this was related to my psoriasis or not, but it appears different as red dots throughout my hand whereas the psoriasis rash was never there before.
Aching joints; severe headache; blotchy skin on arms; This is a spontaneous report from a contactable other hcp reported for herself. A 49-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL1282), via an unspecified route of administration on the left arm on 21Jan2021 11:15 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history was not reported. Concomitant medication included sertraline (SERTRALINE). The patient previously took the first dose of bnt162b2 (lot number: EL0142) for covid-19 immunization on 31Dec2020 and diflucan and experienced drug hypersensitivity. The patient experienced aching joints, severe headache, blotchy skin on arms on 22Jan2021 04:00 AM . The patient underwent lab tests and procedures which included sars-cov-1 test: negative on 22Jan2021. No treatment was received for the events. The outcome of the events was not recovered.
my right eye has begun twitching about 24 hours after my vaccine and is continuing today (about 56 hours post vaccination)
After completing his plasma donation, the donor was administered his first Hepatitis B vaccine of his 3-shot series. The vaccine was administered in the deltoid muscle of his right arm while he was seated upright in a chair.  Immediately after the vaccine was given, the donor lost consciousness for less than 10 seconds.  His body went limp, and his head went down to his chest.  Symptoms included lightheadedness, feeling hot/sweaty, and pale appearance.  Donor was provided Powerade, crackers, and was fanned.  Vital signs were obtained and were at his baseline measurement.  Donor then stated he was feeling better and his symptoms subsided.  Vitals were obtained again and were at his baseline.  Donor recovered appropriately and left center in good condition.
CLAIMANT ALLEGES THAT SHE FELL TO THE GROUND AFTER TAKING COVID SHOT. THE CUSTOMER SUFFERED A LACERATION TO THE LIP
Client received Influenza vaccine 10/29/07.  Reported to HD 11/7/07 after office visit with MD.  Stated she started with rash on her abdomen 11/2/07 that looks like small mosquito bites.  Continued to spread.  Hives type rash noted on abdomen and pelvic area today with itching.  Was put on Medical Doze Pack by MD.  Denies allergies to eggs.  Client to discuss with her allergist prior to next flu shot.
12/19/2021 - Presents to ED from Nursing home SOB, productive cough, weakness.  HR 112, RR 18, BP 185/80, afebrile. WBC 14.1,D-dimer 466, Hb 10.7, CRP 5.2, and Covid +. On admission for Covid pneumonia - saturating 92% Rm air with diffuse bil crackles/Ronchi. Met sepsis criteria.  Started on Cefatriaxone, Doxy, Vitamins, Remdesivir x4doses followed by Decadron x10 days, and O2 to maintain above 88%, Heparing for DVT prop.  12/20 - Baricitinib added for 14 days 12/24 - Remdesivir d/c maintaining o2 sat 96% on RA. 12/27 - Doxy and Ceftriaxone completed. 12/29 - Covid with sepsis resolved. WBC-12.5 Discharged to Nursing home - negative Covid swab.
45 minutes after injection both palms and index finger and middle finger  on both hands were red and itchy.  It lasted 30-45 minutes (while driving home).
Fever (chills), body ache, nausea and generally feeling bad - Extreme on the first night (couldn't get out of bed.).  Lessened the next day.
This spontaneous report was received from a nurse practitioner concerning an approximately 12 year old female patient. On an unknown date in November 2011, the patient was vaccinated with the first dose of GARDASIL (lot number, expiry date, dose and route unspecified) and was in clinic to complete the vaccination series with a second dose of GARDASIL on 06-SEP-2013. No concomitant therapy was reported. No adverse effect was reported. Additional information has been requested.
March 30, 2018 at 4:00 am: vomited twice and was running fever. 6:00 am syncopal episode. Unable to do normal activities for 24 hours. Injection site swelling and muscle aches for 4 + days.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On 18-FEB-2016 the patient was vaccinated with am improperly stored dose of PROQUAD (Merck) (lot # L044055, expiration date 02-MAY-2017. dosage and route not specified). It was reported that the vaccine was stored at -13.7 degree centigrade for 15 hours. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
PERSISTENT NUMBNESS IN LEFT LEG, BOTH ARMS AND RIGHT LEG HALFWAY FROM SIDE OF LEG TO HALFWAY AROUND THE CALF, BETWEEN ANKLE, KNEE AND HIP; LIGHTHEADEDNESS; SORE ARM; MUSCLE ACHES; This spontaneous report received from a patient concerned a 56 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included the patient takes no prescription or over the counter medications and has no medical conditions and describes self as healthy. the patient had no known allergies and was not a drug abuse or illicit drug user.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced sore arm. On 10-MAR-2021, the subject experienced muscle aches. On APR-2021, the subject experienced persistent numbness in left leg, both arms and right leg halfway from side of leg to halfway around the calf, between ankle, knee and hip. On APR-2021, the subject experienced lightheadedness. Laboratory data (dates unspecified) included: Cholesterol (NR: not provided) within range. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lightheadedness, and sore arm, and muscle aches on 12-MAR-2021, and had not recovered from persistent numbness in left leg, both arms and right leg halfway from side of leg to halfway around the calf, between ankle, knee and hip. This report was non-serious.
moderate body aches; fatigue; headache; This is a spontaneous report from a contactable consumer. A 59-years-old male patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration, administered in arm left on 12Apr2021 at 10:30 as a single dose for COVID-19 immunization. Medical history included high blood pressure management. Concomitant medications included atenolol taken for an unspecified indication. Historical vaccine included first dose BNT162B2 on 22Mar2021 at 04:00PM. On 12Apr2021 at 18:00 patient experienced moderate body aches, fatigue and headache. The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Patients received vaccine from vial that was punctured for almost 48hs; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received vaccine from vial that was punctured for almost 48hs) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received vaccine from vial that was punctured for almost 48hs). On 12-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Patients received vaccine from vial that was punctured for almost 48hs) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment information was unknown.