chrisvoncsefalvay/vaers-outcomes huggingface dataset:
knot at the injection site; itchy at the injection site; sore at the injection site; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (knot at the injection site), VACCINATION SITE PRURITUS (itchy at the injection site), VACCINATION SITE PAIN (sore at the injection site) and NAUSEA (nauseous) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced NAUSEA (nauseous). On 10-Mar-2021, the patient experienced VACCINATION SITE MASS (knot at the injection site), VACCINATION SITE PRURITUS (itchy at the injection site) and VACCINATION SITE PAIN (sore at the injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) ongoing since an unknown date at a dose of 1 dosage form. On 09-Mar-2021, NAUSEA (nauseous) had resolved. At the time of the report, VACCINATION SITE MASS (knot at the injection site), VACCINATION SITE PRURITUS (itchy at the injection site) and VACCINATION SITE PAIN (sore at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Follow up received and patient email added
Noted Right shoulder joint pain that began on 2/15/2021.  Sharp, radiating pain that has increased in intensity over the last several weeks.  At times, I am not able to sleep on my right side or sleep through the night due to the right should joint pain.  I have no known injuries to my right shoulder.  Tonight, I literally am not able to lift my right arm, it was difficult to manage the steering wheel while driving due to the pain. It was 10/10.  Noted sharp pain in my left shoulder beginning around 4pm today 3/8/2021, and soreness in right hand finger joints beginning this morning 3/8/2021.  Also noted sore throat upon swallowing beginning today 3/8/2021 at 11am.
Incident happened 9/15/18. Mom did not report until 12/4/18. Mom states patient was walking around "like a drunken uncle" and would repeatedly just collapse 4 days after vaccines were given. Mom could not remember which leg had redness and swelling at shot visit - but states one leg was red and swollen instantaneously, so she is nervous that this was an allergic reaction. She thinks it was MMR because patient had already had PREVNAR x 3. Making you aware B/C she stated she will be very nervous to get second MMR when patient turns four. 03/05/19 (Tue Mar 5) 09:42 PM: mom reports that at patient's 12 month visit she has a a localized reaction to the MMR and we had her wait here for about 20 minutes, then reports that over the next couple of days patient's gait was "wobbly" and she had difficulty holding weight on her legs - although my notes do not state that she was walking...mom would like to report this to VAERS, but likely too late...she does not want to do anymore MMR's...I told her that based on that story, I WOULD NOT write a medical exemption, but we could check her titers. Please see if we have documentation that she had hives with the vaccines.
New dermatographism rash throughout body. Itchy, raised, red localized swelling caused by any slight scratch, touch, or period of use (hands).
Upon admittance to ER on 08/11/2021, I was diagnosed with dizziness (Vertigo), nausea, weakness.  Blood pressure was 180/78.  Had an MRI and CT.  Was told to follow up with neurologist and PCP.  Dizziness has been off and on since the ER visit with vestibular therapy as a treatment.  Have also experienced anxiety and have been under the care of a psychiatrist. Diagnosis is Vestibular Neuritis and anxiety.   Note:  have received the 2nd vaccine plus the booster.
This spontaneous report has been received from a nurse/administrator and referred to a 69-year-old female patient. The patient's relevant concurrent conditions included a drug/allergy to Iodine. She did not have any relevant historical conditions and concomitant therapies to be reported. On 10-MAY-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 intramuscularly in her right upper arm (strength, dose, and frequency were not reported; lot number M022947 with an expiration date 11-NOV-2017) for prophylaxis. Then on 11-MAY-2017, the patient went to the nurse's office and she presented at the injection site phlebitis, cellulitis, tightness (almost bursting) and was extremely painful. On the same day, the patient was ordered for an ultrasound to rule out a deep vein thrombosis (DVT) (results not provided). The patient was started on therapy with clindamycin, BACTROBAN, BENADRYL, and PEPCID. At the time of this report, the outcome of cellulitis, phlebitis, muscle tightness and pain in extremity was unknown. The causality assessment between cellulitis, phlebitis, muscle tightness and pain in extremity with PNEUMOVAX 23 was not reported. Upon internal review, cellulitis was considered as a medically significant event. Additional information has been requested.
Pt recvd series of Hep vax 5yrs ago; Needed repeat series; About 2 wks p/first shot, pt noticed intense fatigue, a lot of sleeping; 3 days p/2nd shot pt became nauseated, weak, hives on hands & feet, swelling of lips, fever, vomiting;
administered one dose of the monovalent vaccine which was beyond the 30 day use by date on 26Oct2022; given vaccine which was beyond the 30 day use by date; administered one dose of the monovalent vaccine which was beyond the 30 day use by date on 26Oct2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered one dose of the monovalent vaccine which was beyond the 30 day use by date on 26Oct2022), PRODUCT STORAGE ERROR (administered one dose of the monovalent vaccine which was beyond the 30 day use by date on 26Oct2022) and NO ADVERSE EVENT (given vaccine which was beyond the 30 day use by date) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 053B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Oct-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 26-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered one dose of the monovalent vaccine which was beyond the 30 day use by date on 26Oct2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (administered one dose of the monovalent vaccine which was beyond the 30 day use by date on 26Oct2022) and NO ADVERSE EVENT (given vaccine which was beyond the 30 day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered one dose of the monovalent vaccine which was beyond the 30 day use by date on 26Oct2022), PRODUCT STORAGE ERROR (administered one dose of the monovalent vaccine which was beyond the 30 day use by date on 26Oct2022) and NO ADVERSE EVENT (given vaccine which was beyond the 30 day use by date) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (given vaccine which was beyond the 30 day use by date) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (administered one dose of the monovalent vaccine which was beyond the 30 day use by date on 26Oct2022) and PRODUCT STORAGE ERROR (administered one dose of the monovalent vaccine which was beyond the 30 day use by date on 26Oct2022).    No concomitant drug were reported.  Initial date the vial was placed in the refrigerator on 18-Aug-2022. Pharmacist reported that they administered one dose of the monovalent vaccine which was beyond the 30 day use by date on 26-Oct-2022.   Manufacturing expiration date was not looked up.  Vial size was reported as 5.5ml.  The vial did not undergo any temperature excursions. No treatment drug were reported.
the vial was initially stored in the refrigerator on 22Apr2022 and administered after 30 days beyond use date on 23May2022; gave a 2nd booster dose today of the Moderna Covid-19 Vaccine that was past the beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (gave a 2nd booster dose today of the Moderna Covid-19 Vaccine that was past the beyond use date) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 22Apr2022 and administered after 30 days beyond use date on 23May2022) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (gave a 2nd booster dose today of the Moderna Covid-19 Vaccine that was past the beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 22Apr2022 and administered after 30 days beyond use date on 23May2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (gave a 2nd booster dose today of the Moderna Covid-19 Vaccine that was past the beyond use date) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 22Apr2022 and administered after 30 days beyond use date on 23May2022) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The vials were initially stored in the refrigerator on 22-Apr-2022.  It was states that gave a 2nd booster dose of the Moderna Covid-19 Vaccine that was past the beyond use date. Vial did not undergo any temperature excursion. No treatment medications were reported.
Patient after 3 episodes of bloody diarrhea and non-productive cough over 10 days.
21MAR99 seen in ER for maculopapular, erythematous rash over face, arms,legs;+pruritus;negative hives;
No additional adverse effect reported; The second and third dose are also outside the administration schedule; This spontaneous report was received from a clinical coordinator refers to a 12 years old male patient. There was no information about the patient's concurrent conditions, drug reactions, allergies, medical history, and concomitant therapies provided.  On 28-OCT-2018, the patient received his first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # R008164, expiration date not reported, but upon internal validation established as 12-NOV-2020)(strength and anatomical location were not reported) intramuscularly for prophylaxis. On 06-JUN-2019, the patient received his second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # R011630, expiration date not reported, but upon internal validation established as 12-DEC-2020) (strength and anatomical location were not reported) intramuscularly for prophylaxis. On 22-OCT-2019, the patient inadvertently received a third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # R029512, expiration date not reported, but upon internal validation established as 08-JUL-2021)(strength and anatomical location were not reported) intramuscularly for prophylaxis(inappropriate schedule of product administration). The patient was eligible for a two dose series which was administered on 28-OC-2018 and 06-JUN-2019 which was within the 2 dose schedule listed in the prescribing information. It is unknown if there were any temperature excursions for the three lot numbers. No additional adverse effect reported.
My tinnitus got much louder and has not subsided since May.   Along with my tinnitus getting worse I have had a continual Ulcerative Colitis flare up unlike any flare up  since May as well.
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.  An 81-year-old male patient received BNT162b2 (BNT162B2), on 06Apr2022 as dose 4 (booster), single (Lot number: FM9992), in left arm 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: "Known Allergies: Shell Fish" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.
COVID Rebound; COVID Rebound; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 74-year-old male patient received BNT162b2 (BNT162B2), on 12Feb2021 at 10:00 as dose 1, single (Lot number: EL9266), in left arm and on 05Mar2021 at 09:00 as dose 2, single (Lot number: ER6203) at the age of 72 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID Rebound". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (unspecified date) Positive, notes: COVID 19 Treatment; (18Aug2022) Positive, notes: COVID Rebound. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: No other medication in 2 weeks. Anti viral details includes covid 19 treatment for paxlovid,treatment start date is 05Aug2022 and treatment stop date is 10Aug2022. Indication for treatment of covid-19, no known allergies.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On unknown dates in 2014, reported as from 10-JUN-2014 to 18-JUL-2014, an unspecified number of patients were vaccinated with doses of VAQTA (dose number, dose, route and lot number were not reported), which were improperly stored. No adverse events were reported. Concomitant medications were not specified. Follow up was received from a medical assistant and refers to a 4 years old patient of unknown gender. On 10-JUN-2014 the patients was vaccinated with a dose of VAQTA lot # K000943 and expiry date 24-SEP-2016 (dose, route not reported) that on 10-JUN-2014 had been exposed to 51 degrees Fahrenheit for 51 minutes. This is one of several reports received from the same reporter. Additional information is not expected as no follow up was obtained.
6 year old received Pfizer Covid-19 Vaccine. Child could not walk 6 hours later. Ha to visit hospital. They diagnosed  it as Water on the Hip, due to inflammatory reaction to vaccine / virus. We consider this an adverse event to the recently approved children's vaccine. We are closely monitoring our child.
This spontaneous report was received from a Doctor of microbiology concerning to a male patient of unknown age. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route and lot not reported). No other co-suspects were reported. No concomitant medications were reported. The microbiologist stated that she received an isolette sample from the physician for the patient who received ZOSTAVAX and developed rash. The microbiologist stated this patient was taking immunosuppressives at the same time he received the vaccine and was hospitalized for 5 days. No treatment information was reported. At the time of the report, the patient had not recovered from rash. The relationship between the event and ZOSTAVAX was not reported. Additional information has been requested.
1/5/2021 at 3am I woke up feeling very lightheaded and dizzy. Went back to sleep and  At 7am  woke feeling same. I took routine vitamins and 2 extra strength  Tylenol.  Symptoms lasted all day with difficulty walking due to the dizziness. Also had difficulty focusing, blurry vision.  1/6/2021 still a little lightheaded just a little dizzy.  Headache ( I have routine headaches).   lightheaded and dizziness  decreased with each day.
One day after the second dose I felt a large lump, approximately 14mm right below my clavicle, I'm assuming it was a clavicular lymph node.  It has now subsided 30 days afterwards.
within 48hrs severe chest pain; 12 hours of vomiting; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 34 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Sep2021 (Lot number: FF2588) at the age of 34 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LEXIPRON; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; PANTOPRAZOLE; DICYCLOMINE. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FF2588, Location of injection: Arm Left), administration date: 05Sep2021, when the patient was 34 years old, for covid-19 immunization, reaction(s): "pain in the injection area", "Five days of headaches", "Chills", "Aches", "fatigue". The following information was reported: CHEST PAIN (hospitalization), outcome "recovering", described as "within 48hrs severe chest pain"; VOMITING (hospitalization), outcome "recovering", described as "12 hours of vomiting". The events "within 48hrs severe chest pain" and "12 hours of vomiting" were evaluated at the physician office visit and emergency room visit. It was unknown if therapeutic measures were taken as a result of chest pain, vomiting.
Dizziness for 2 days, then resolved independently. Did not inform us until she presented for her next immunization 4 weeks later.
Injection site redness that radiated several inches past site, swelling, and painful area. Physician prescribed Keflex, and Medrol dosepack.
Left thigh with 2-3 in. erythematous ring with underlying nodule. (1) BENADRYL (2) OMNICEF 250/5 - 3ml BID.
p/ pt recv vax became preg. on 3/5/99 pt delivered by C-section a normal, health baby  at 41 weeks gestation. it was rpt fetus would not descend & fetal distress occurred.
Case number PHEH2013US005302 is an initial spontaneous report received from a medical assistant on 28 FEB 2013 with a follow up information received on 25 MAR 2013. This report refers to a 15-year-old female patient. She was vaccinated with MENVEO (batch number M11051 and expiry date: 31 MAR 2014) intramuscularly at a dose of 0.5 ml on 15 FEB 2013. This vaccine had undergone temperature excursion. The first temperature excursion took place on 23 JAN 2013 and the vaccine reached 54 degree Fahrenheit for less than four hours. MENVEO was not re-constituted at the time of excursion. The reporter confirmed that the patient did not experience any adverse events as a result of temperature excursion. The patient would be re-vaccinated. No further information was reported.   Follow up information received on 25 MAR 2013: Reporter's comment updated.
Weekly Migraines from 4/24/2021 through the end of June 2021 when I had my Neurologist give me a shot to stop them.  I am still getting them at least once per month.  I also had menstrual bleeding for one day.  I have not had my period in almost three years after an uterine ablation stopped my periods completely.
Large blister on lower lip-never occurred before; Fever; Chills; Muscle aches in legs; Headache; Tiredness; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 10 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Nov2021 (Lot number: FK5127) at the age of 10 years as dose 2 (tris), single for COVID-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19: Yes. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1 (TRIS), SINGLE ; Lot Number: FK5127; Anatomical site: left arm; Route of administration: unspecified), administration date: an unknown date in Nov2021, when the patient was 10 years old, for COVID-19 immunisation.  The following information was reported: LIP BLISTER (non-serious) with onset 30Nov2021, outcome "not recovered", described as "Large blister on lower lip-never occurred before"; PYREXIA (non-serious) with onset 30Nov2021, outcome "not recovered", described as "Fever"; CHILLS (non-serious) with onset 30Nov2021, outcome "not recovered", described as "Chills"; MYALGIA (non-serious) with onset 30Nov2021, outcome "not recovered", described as "Muscle aches in legs"; HEADACHE (non-serious) with onset 30Nov2021, outcome "not recovered", described as "Headache"; FATIGUE (non-serious) with onset 30Nov2021, outcome "not recovered", described as "Tiredness". The events "Large blister on lower lip-never occurred before", "Fever", "Chills", "Muscle aches in legs", "Headache" and "Tiredness" were evaluated at the physician office visit. Therapeutic measures were taken as a result of lip blister, pyrexia, chills, myalgia, headache and fatigue.  Additional Information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. The patient also had a fever, chills, muscle aches in legs, headache, and tiredness which are already known side effects. It was not sure if the challenge to the immune system allowed a previous exposure to a virus causing lip blisters to surface. Therapeutic measures included unspecified over-the-counter (OTC) cold sore medicine. Since the vaccination, the patient had not been tested for COVID-19.