chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional ae reported; MMR II was administered to 2 patient's; This spontaneous report was received from a nurse referring to a 13-year-old female patient. The patient's medical history and concurrent conditions were not reported. Concomitant therapies were not provided.  On 06-SEP-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection (lot #T029549 with an expiration date on 10-SEP-2022), administered for prophylaxis (strength, and route of administration were not provided) (expired product administered).  No additional adverse events were reported. This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2210USA001505:
Headache, Myalgia, Arthralgia, Fever, fatigue, chills, injection site pain Narrative:
Covered with chicken pox, more than 100 all over face and body. Sulfa: tx rx
soar thoart; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (soar thoart) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No medical history was reported.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (soar thoart). At the time of the report, OROPHARYNGEAL PAIN (soar thoart) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medication was reported , No treatment medication was reported .   Reporter did not allow further contact
This spontaneous report was received from a physician concerning a 26 year old female patient. The patient had no pertinent medical history or drug reactions or allergies. The patient was not pregnant. On 18-SEP-2015, the patient was vaccinated with the first dose of GARDASIL 9 (Lot#, dose and route not provided). There were no concomitant medications. On an unspecified date in 2015, after receiving the GARDASIL 9 the patient experienced swelling at the injection site. On an unspecified date in 2015, the patient's whole arm eventually swelled up and the swelling lasted for one full month. No treatment was given for the patient's adverse event. On an unspecified date, the swelling resolved on itself. The patient did not seek medical attention. Additional information has been requested.
Beginning in the first week in November I started developing a severe hives. I went to urgent care and was prescribed antihistamine. It was successful in treating the itching but not the hives. I was referred to a Dermatologist and she put me on a 16 day course of prednisone. At this time I have not improved. My next step would be to see an allergist if my condition does not improve.
This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. The patient's medical history, concomitant medications and drug reaction or allergies were not reported. On 08-JUN-2017 the patient was vaccinated with M-M-R II, albumin status unknown; and with VARIVAX (dose, frequeny, administration route, lot number, expiration date and indication were not reported for both vaccines). A sterile diluent (manufacturer unknown) (lot number and expiration date were not reported) was used in the vaccination. It was reported that on 08-JUN-2017, the patient was diagnosed with cellulitis after receive M-M-R II and VARIVAX. The pharmacist also reported two additional patients, who experienced the same reaction after vaccination (the patients' experience was captured in MARRS number 1706USA005020). The pharmacist also stated that on 08-JUN-2017, the patient went to the emergency room of an unspecified hospital. The patient's outcome was reported as not recovered. The causality assessment between M-M-R II; VARIVAX, the sterile diluent (manufacturer unknown) and the cellulitis event was unknown at the time of reporting. Upon internal review, the event of cellulitis was determined to be medically significant. Additional information has been requested. Sender's Comments: US-009507513-1706USA005020.
Very fast heart rate, didn't know it could be caused from the shot. Laid down awhile, tried to stay calm.  Told my son my heart was beating really fast, didn't know why.
Pfizer-BIONTECH COVID-19 vaccine EUA .  I broke out in a fast spreading rash that started out as a few small spots on my arms and legs and 8 hours later it completely covered my arms, legs, and waist.  I called a nurse who told me I was having a allergic reaction and to go to the emergency room where  I was given steroids to clear up the rash.  Two days later the rash was gone.
Fever (up to 100.8), diarrhea, vomiting, body aches, redness and heat at vaccination site, headache
blood clot; hand and legs cramps/ay 3 and 4 after the shot her cramps moved to both thighs, in lower right leg, in the sides; earache and pain in the right side of her neck; earache and pain in the right side of her neck; felt clammy; her voice is "rafty" now; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient's medical history included allergy to 6 other medications. The patient's concomitant medications were not reported. The patient stated that she experienced hand and leg cramps after the second dose. The patient further stated that her cramps got really bad and her doctor suggested her to drink tonic water each day. The patient stated that on day 3 and 4 after receiving the shot, her cramps moved to both thighs, in lower right leg, in the sides. The patient stated that she also experienced earache and pain in the right side of her neck, felt clammy. The patient stated that she could not check for fever. The patient thought like she has a blood clot traveling in the body, her voice was rafty now. The patient also stated that the pain in the neck right side, cramps in the legs were similar to her allergic reaction after medication. The case was considered as serious (medically significant). The outcome of the events was unknown.  Information on lot/batch number has been requested. Follow-up attempts not completed; information about lot/batch number cannot be obtained. No further information expected.
Fever , muscle fatigue in the legs and tingling in my legs  when I sit, lower back pain, mild headaches
Patient was given the vaccine while seated.  Patient was accompanied by a family member.  After shot was given patient decided to stay seated while family member paid.   Within minutes, patient passed out and rolled out of chair.   RPh and family member kept patient on her side until patient woke up,  patient remained lying down until medical assistance arrived.  patient only sat up with assistance,  and remained in the pharmacy for 20-30 minutes until felt comfortable to sit up.   Medical assistance checked vitals, and applied cold pack to back of neck.     When patient felt well enough and refused medical transport then medial assistance left.      When patient was comfortable she was transported to vehicle per wheelchair and taken home by family member.     Family member called back at end of day and stated that the patient had rested for several hours and was feeling much better.
No Adverse event; Received doses out of the wrong vial/ were supposed to get the bivalent vaccine, but they got the original; This spontaneous case was reported by a medical assistant and describes the occurrence of WRONG PRODUCT ADMINISTERED (Received doses out of the wrong vial/ were supposed to get the bivalent vaccine, but they got the original) and NO ADVERSE EVENT (No Adverse event) in a 60-year-old male patient who received mRNA-1273 (Spikevax) (batch no. AR5186C) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Oct-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 17-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Received doses out of the wrong vial/ were supposed to get the bivalent vaccine, but they got the original). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Received doses out of the wrong vial/ were supposed to get the bivalent vaccine, but they got the original) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Received doses out of the wrong vial/ were supposed to get the bivalent vaccine, but they got the original).    No concomitant drug were reported.   Patient were supposed to get the bivalent vaccine, but they got the original. Date of administration was 17-Oct-2022. There were no temperature excursions involved, and the vaccine was not expired.   No treatment drug were reported.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-666046:Same reporter
3-31-08 Started with small red area, today 4-3-08 it was 5 1/4 in x 3 14 in area, red & warm to touch.  He was given Prelone 15/5 9 cc daily x3, ice & Motrin.
Injection on may 6th, on my seventh around 12pm, lymph nodes near ear and below jaw became wnlarged and sore,, noticed red hot itchy spot on left cheek. Progressively expanded through the day, accompanied by fever, body aches. Each day has gotten progressively worse. Rash spreading to scalp following day and migrating left to right across face. May 9th went to emergency room for treatment. Prescribed zyrtec, benadryl and prednisone along with Valtrex. Unable to identify cause of rash. As of May tenth the rash has continued to grow and is now on spread to the top of my scalp, back of my skull and pain as shown up in nerve in jaw on right side
presents with a potential reaction to the COVID19 vaccine. The patient was evaluated in his vehicle. The patient's wife (passenger) reported that as he pulled into the monitoring area, he become disoriented and pale. Upon evaluation, the patient was found to be significantly diaphoretic, pale, and mildly disoriented. Initial vitals revealed a pulse of 45, SpO2 of 86%. No BP was obtained at the time, but the patient was clearly hypotensive. The patient was laid supine in his seat and given aggressive oral hydration.  After aggressive hydration and close monitoring, the patient rapidly improved and returned to baseline with normal vitals. He was returned home with his wife as drive.
Pfizer-BioNTech COVID-19 Vaccine EUA Vagal Near-Syncope
Syncope with myoclonic jerks immediately following HPV vaccine last aprox 30 seconds, vital signs showed blood pressures 90's/50's, heart rate 50's-70's. Felt dizzy, unwell. After 1 hour of drinking fluids, resting, felt well again.
3 days after vaccine woke up with severe fever, sweating profusely, UTI that turned into kidney infection. Took antibiotics. Later passed several kidney stones. No history of kidney infection or UTI.
Left deltoid red/warm marked local reaction. Treatment -cold compresses, ibuprofen, Cephalexin 375 mg tid x 5-7 d
On 12/10/2022, I started experiencing symptoms of sore throat, which turned into a wet, productive cough, congestion and fatigue. I tested for Covid-19 on 12/10/2022 and it was negative but received a positive result on 12/11/2022. I contacted my physician to inform them of a positive result. I was not eligible for PAXLOVID, but I was prescribed medication for my cough. I tested today, 12/16/2022 and the test was still positive.
Taste was different and still hasn't gone away; Really nauseous; metallic taste; This is a spontaneous report from a contactable consumer. A 17-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on arm left 13May2021 (Age at Vaccination: 17 years) as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history was reported as none. Prior Vaccinations (within 4 weeks) and adverse events following prior vaccinations was reported as none. Family Medical History Relevant to Adverse events was reported as none.  The patient Concomitant medications were not reported. Historical Vaccine included She received allergy shots. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on 22Apr2021 (at the age of 17 years) as DOSE 2, SINGLE for COVID-19 immunisation. She got her second dose 6 weeks ago and on 15May2021, the patient experienced taste was different and still hasn't gone away. She was reading that it is kind of uncommon to still get a metallic taste. On an unspecified date in May2021, after the second dose, the patient experienced really nauseous and then started noticing her taste was different and she just stopped eating things that taste weird mainly meat. Treatment received for Taste was different and still hasn't gone away was reported as no. The Relevant Tests was reported as none. The outcome of the event nausea was unknown, while other events was not recovered.  Information on the lot/batch number has been requested
Severe pain in left arm, severe limited range of motion a few days after administration. Have seen Dr. 4 times since. Took steroids for 10 days.
little sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (little sore arm) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in 2020, Hypoxia (Oxygen level had dropped to 80) on 05-Nov-2020, Heart attack, STEMI (15 Stems), Hospitalization (for 6 days.) on 05-Nov-2020, Oxygen supplementation (On oxygen for 3 weeks), Bypass surgery (Triple bypass) and Weight control. Concurrent medical conditions included Diabetes.    On 25-Feb-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 PAIN IN EXTREMITY (little sore arm). At the time of the report, PAIN IN EXTREMITY (little sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient state they take around 20 different pills a day because of their heart condition. No treatment details were reported.   This case was linked to MOD-2022-440853, MOD-2022-440854 (Patient Link).
Pt called to find out if she can take her 2nd dose of hep A vaccine since she had what she claims as reactions. A week after receipt of vaccine she felt that she has something in her throat, hives in her neck/nape, redness/burning sensation of her ear.
SEIZURE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered on 08-APR-2021 to left deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 12-APR-2021, the patient experienced seizure which lasted for one minute 30 seconds. The patient did not take any medication for her seizure. She never had a seizure before and did not know if there was a correlation with vaccine or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from seizure on 12-APR-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0;20210424312-covid-19 vaccine ad26.cov2. s-seizure. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
I felt like I was coming down with a head cold and since I was going out to meet people, so I tested myself. I tested positive. I developed a stuffy head and a mild scratchy throat with no fever. On September 25, I tried telemedicine from the pharmacy, and they advised that since my symptoms were so slight to take TYLENOL. I contacted my primary care doctor on September 26, and he recommended that I take PAXLOVID. I completed the PAXLOVID on October 1. I tested myself again on this date and I was negative. I have completed recovered from all my symptoms currently.
had issues with the needle they used on the syringe, causing some of the vaccine to leak out with no AE; about 1/4 to 1/2 of the Flublok leaked out onto the patient's arm  with no AE; about 1/4 to 1/2 of the Flublok leaked out onto the patient's arm with no AE; patient who is 33 weeks pregnant was administered Flublok with no AE;Initial information received on 09-Nov-2021 regarding an unsolicited valid non-serious case from a pharmacist via Media Information (under the reference 00850145).   This case involves a 30-years-old female patient who was exposed to vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] and had issues with the needle they used on the syringe, causing some of the vaccine to leak out onto the arm (needle issue, underdose, exposure via skin contact and maternal exposure during pregnancy).  Data regarding this pregnancy were received prospectively.  The gestation period at onset 33 weeks.  The date of last menstrual period was not reported.  The estimated due date was not reported.  The patient past medical history, medical treatment, vaccination and family history were not provided.  The patient had unknown previous pregnancy.  On 09-Nov-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot QFAA2117 and expiry date: 30-Jun-2022, Injection) via intramuscular route in Deltoid not otherwise specified (nos) for prophylactic vaccination.  It was a case of actual medication error due to needle issue, underdose, exposure via skin contact (latency same day).  It was also the case of vaccine exposure during pregnancy (latency same day).   At the time of reporting, no adverse event was reported.   Pregnancy outcome was unknown at the time of report.
Patient was given a Pfizer 30 Mcg IM injection. Patient had a period of dizziness and feeling flushed. Patient reported her throat felt scratchy. Blood pressure was taken 114/82. Reaction stopped and no medications were given. Pharmacist was notified of the reaction. The reaction was noted at 10:50.
Information has been received from a registered nurse concerning a 11 year old female with no pertinent medical history or drug reactions/allergies who on 07-MAR-2011 (also reported as 08-MAY-2001) was vaccinated SC with 0.5 ml VARIVAX (Merck) (lot # 668602/1273Z, Exp. September 2012). There was no concomitant medication. On 08-MAR-2011 the patient's father called the physician's office to report that the patient had developed a painful, no itchy, "red welt" at the injection site that was the size of a golf ball. The patient was treated with MOTRIN and BENADRYL. On 10-MAR-2011 the patient came to the physician's office and the injection site was noted to be red and warm to touch. The diameter of the red area was 3-4 centimeters. The registered nurse reported that the patient's father reported that the diameter of the red area was growing in size, but that the redness was fading and the pain was less. The patient did not recover from these events at the time of this report. No lab diagnostic studies were performed. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The pharmacist heard that on an unknown date the patient was vaccinated with ZOSTAVAX (lot #, expiration date, dose and route unspecified). On an unknown date the patient might have developed type 1 diabetes after administration of ZOSTAVAX. The event outcome was unknown. Additional information has been requested.
By 12:30am I had fever of 100.4, my injection site was rock hard and I was sweating with chills. Throughout the night I began having severe body aches. My fever came and went several times, at one point hitting 103 degrees. I had extreme swelling in my face, hands and feet. On the 27th my fever broke and hasn't returned. I'm still fatigued but getting better.
Lethargic; Headache; Light headed; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 16Apr2021 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included heart PVCs (premature ventricular contractions). The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 19Mar2021 at 11:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. On 17Apr2021 at 11:00, the patient experienced headache and was light headed. The patient was also lethargic. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events lethargic, headache and light headed were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
flu; Initial information received on 28-Jan-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and gender patient who experienced flu after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was unknown if the patient had any medical history, concomitant disease or risk factor.    On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (dose, strength, formulation, expiry date and lot number not reported) via unknown route in unknown administration site for flu.  On an unknown date the patient developed flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if there were lab data/results available.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (flu).  At time of reporting, the outcome was Unknown for the event flu.