chrisvoncsefalvay/vaers-outcomes huggingface dataset:
itchiness; This is a spontaneous report received from two contactable consumers. A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection) via an unspecified route of administration in left arm on 09Apr2021 at single dose for COVID-19 immunization. Patient medical history included seizures and heartburn bot are ongoing. Concomitant medications included levetiracetam and phenobarbital both for seizures and dexlansoprazole (DEXILANT) for heartburn. It was reported as patient received her first dose of the Pfizer vaccine Friday. She is experiencing itchiness post vaccination on 12Apr2021. Outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Right side mouth and tongue tingling, PO 25 mg Benadryl given Vitals signs WIL
PATIENT REPORTED GENERAL MUSCLE WEAKNESS ON 4-14, NO SHORTNESS OF BREATH OR S/S OF CLOTTING
A solicited report has been received from a Health professional concerning a child patient, enrolled in a study. Patient relevant history, concurrent diseases and concomitant drugs were not reported. Patient had been receiving FLUMIST QUADRIVALENT (intranasal), started on 15-Oct-2014. The patient had influenza A on 21-Nov-2014. The outcome of the event of influenza A was unknown. The report was considered to be non-serious. Based on the information in this report, and awaiting the reporter's assessment, the company physician considered the event influenza A to be not related to FLUMIST QUADRIVALENT.
Maculopapular rash on trunk, neck, face, arms, legs. Patient seen in office at 2:00 pm 3/30/23
injection site swelling; This spontaneous report was received from a physician refers to a 51 year old female patient. The patient was diabetic and was having allergy/reaction (unspecified) to glyburide. Concomitant therapies included insulin human(HUMULIN).   On 28-AUG-2018, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (strength and dose were not reported) (lot # S012822 has been verified to be a valid lot number with expiration date 21-FEB-2021) via intramuscular route for prophylaxis. After receiving vaccination, the patient experienced injection site swelling. It was reported that the injection site swelling went away after rubbing the area (recovered/resolved) on the same day. The reporter's causality assessment was not reported. No product quality complaint was reported.
patient developed SOB, red face, pain in chest under breasts and rapid heart beat within 1 minute of flu shots, we called 911. EMT came and patient BP was 160/90. She felt better by 5:40pm and refused further TX.
REACTION TO BOOSTER  no issues with first 2 vaccines.   Had covid first week of december. 4 weeks later was told to get booster.   Redness/swelling at injection site hours after vaccine  Delayed allergic response  24 hours later ER visit for allergic response.  Elevated HR, Rash face,chest, and arms, leg spasms, tingling in both left and right legs,face puffy,  sinus tachcardyia  Issues still not resolved coming out of ER  ER Visit multiple times after  For reaction not being resolved  Eventually seen by allergist who starts anthistimaine medication round the clock
patient had red arm, but subsequently developed small itchy spots with white rims and hard white center. on both arms Saw internist who stated she thought it was a dermatitis and prescribed steroid cream.  Patient felt that since it developed a few days after her vaccination it might be from that
Patient is 17 year old female presented today for scheduled pediatric nurse visit. While covering for Pediatric nurse I brought patient into exam room with phone for interpretation for mother. Patient due for Meningococcal, Meningococcal B, and Covid-19 Vaccine. Asked patient and mother if she would like daughter to have all three vaccines and they both verbalized yes. Patient requested J&J vaccine, informed patient that Pfizer was the only vaccine approved for individuals under the age of 18. Both mother and daughter verbalized patient would like Pfizer, meningococcal and men B. Administered Meningococcal and Meningococcal B in right arm and Pfizer 0.2mL for ages 5-11 in Left arm as requested by patient. Realizing the error immediately, went to lead nurse and we reviewed guidelines for error. Went in room and explained error to patient and scheduled for correct Pfizer dosage to be given in 21 days per protocol. Patient and mother was very understanding and did not have any further questions or concerns.
Within 1 week, it triggered a bad MS attack. It should not be given to autoimmune people. First I got numbness in one hand, then the other. My mri showed an enhancing cervical spine lesions cotreslsting with these symptoms. Then a week later I lost sensation in my foot, then the other, then spreading up my leg, I?m in the hospital now on days of high dose steroids. My nurse told me I?m not the only one she sees here this happens to as well as other autoimmune patients of other autoimmunity. I think those of us autoimmune who are not taking immune suppressing drugs get even worse flare ups. This needs to be a warning to people. They could become permanently disabled G-d forbid.
Patient reported feeling severe chills, shaking, warmth and aching the evening immediately following vaccination. This was more intense than the mild to moderate aching she experienced following Shingrix #1. She dosed 2 extra strength TYLENOL tablets which provided relief. Following morning symptoms largely improved, but continues to dose TYLENOL q6h.
Pain at vaccine site following injection. Persisted for 3 days.  Rash developed at vaccine site the day following injection.  Persisted for 3 days. On day 8, rash returned at vaccine site.  Mild rash developed on torso day followin injection, persisted for 3 days
pt was inadvertently given SQ instead of IM vax & exp dermatological effects only (redness, warmth & swelling) to face & inj site; these effects subsided p/3-4 days; no medical intervention was sought for tx w/prescription med;
On 07/12/2022 I got a big red bump but other than that I just felt tired. On Wednesday the 13th, I went out to breakfast and felt fine and was playing peek-a-boo and turned my head to the side and got extremely dizzy. It took about an hour before the dizziness went away but I didn't feel good. I went to the ER and they did a lung x-ray, EKG, blood work, and checked my blood pressure and said I was fine. The rest of the day I wasn't dizzy but I woke up at 1 AM the next day and had full blown vertigo and couldn't stop spinning and had nausea. Thursday I called PCP and she had me take meclizine 3x a day and ZOFRAN and it took 5 days before it was completely gone.
Allergic reaction; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunisation. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "Caller wanted to know the amount of polyethylene glycol in each dose of the Comirnaty vaccine as she is allergic to it and because her allergist informed her that she might have more problem with the second dose than the first dose".  Additional information: Reporter wanted to know the amount of polyethylene glycol in each dose of the Comirnaty vaccine as patient was allergic to it and because her allergist informed her that she might have more problem with the second dose than the first dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a Licensed Practical Nurse, referring to a 47 year old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions or drug reactions. The patient's concomitant therapies included sterile diluent (DILUENT MRK). On 10-NOV-2017, the patient was inadvertently vaccinated with PROQUAD subcutaneously, lot # N002917 and expiration date on 24-JUL-2018 (dose was not reported) for prophylaxis; instead of VARIVAX (dose, route lot number and expiration date was not reported) for prophylaxis (wrong drug administered) (drug administered to patient of inappropriate age).    The reporter stated that, the patient did not experienced any adverse event.
got / first dose of Shingrix on 11/27/20 but could not get the 2nd dose; This case was reported by a consumer via  interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 27th November 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The patient reported this case for herself/himself. The age at vaccination was not applicable to this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient wanted to know if he/she should get the 2nd dose only or get the first dose again. The reporter consent to follow up. This case has been linked with case US2021AMR150814, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR150814:same repoter (husband´s case)
Redness on left arm below injection site, warm to the touch. Rash on neck, chest, back, and stomach. Denies any shortness of breath or difficulty breathing. Reports previous similar reaction to a vaccine in the past. She reports she is going to take oral Benadryl and she has contacted her primary care physician.
I administered hep A 1440 el.u instead of 720 el.u to the patient by mistake. I called the manufacture for any possible side effects and they said they had completed studies on toddlers who received the 1440 el.u dose. The only reaction reported was redness at the injection site, headache, and mild swelling at the injection site. I called the mother of the patient and explained what had happened. She understood and had no other questions. I called back the next day and she reported her daughters arm was a little sore but no other side effects noted. I told her to call if she had any other question.
Was on day 2 or 3 when received vaccine. Days 2-4 or 5 are usually heaviest for me. Within 24h ofreceiving vaccine period stopped. Have he period for 20 years. Never this short.; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0173) via an unspecified route of administration in the right arm on 03May2021 at 10:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had known allergy to lactose. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other vaccines within four weeks prior to the vaccination. The patient received Ok (unspecified) medication within two weeks of vaccination. On 04May2021 at 00:00 the patient's period stopped within 24 hours after receiving vaccine. It was reported that the patient was on day 2 or 3 when she received the vaccine. Days 2-4 or 5 were usually heaviest for her. Within 24 hours of receiving the vaccine, the period stopped. She had her period for 20 years and was never of this short. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had been tested for COVID-19. On 11Jan2021, the patient underwent Rapid COVID-19 virus test (nasal swab) and the result was negative. The clinical outcome of the event within 24 hours of receiving vaccine period stopped was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
10/11/06 given TD IM lot 03915 right deltoid. 10/16/06 had 70x115 local redness and warmth no tenderness.
I had palpitations within 15 min from the shot. My nervous system reactions escalated for the rest of the day, with a peak 2 hours after the shot : burning sensation on my chest, back of the head, down my spine, shakes, digestive issues etc. It seemed to have put my nerves in an electrical plug with little I could do at a cognitive level
Generalized hives appeared, with several around the injection site but most spread over my abdomen.
Patient became lethargic with shortness of breath (vasovagal syncope). Patient put in semifowlers position and 2L of O2. Patient placed in dark room while vitals monitored (stable). D/c in stable condition.
This spontaneous report was received from a physician and from a support services director via company representatives and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 20-FEB-2016, the patient was vaccinated with a dose of an improperly stored GARDASIL 9 (strength: 0.5 ml) lot # L014198 and expiration date: 05-SEP-2017 (dose, anatomical location and route of administration were not reported). No adverse effects were reported. The dose of the vaccine was exposed to a temperature excursion (date unspecified): lasting for 120 hours, with the highest recorded temperature of 53 degrees Fahrenheit (11.66 degrees Celsius). The vaccine was stored in a refrigerator. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Patient  received incorrect Moderna 6M-5Y formulation.  Patient was scheduled for Moderna Bivalent Booster and received a monovalent formulation for their age group.  Patient had previously completed primary series and did not require a 3rd dose of the monovalent formulation.
The morning after (04/15/21), I woke up with soreness and slight redness. As of today (04/28/21), a red circle with the diameter of more than 1 inch, slightly tender on my left arm. Gradually increased in size over the last 2 weeks. My whole body is itchier than normal. I'm now using a body lotion daily so I have not experienced much itchiness since. I've been very fatigued & irritable. My headaches have gotten worse and I haven't had much of an appetite.
Patient stated she  was still experiencing rash, itching, swollen rash on injection arm 10 days after vaccination.
No Adverse event; administered 13 doses of Moderna COVID-19 Vaccine after more than 30-day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered 13 doses of Moderna COVID-19 Vaccine after more than 30-day use by date) and NO ADVERSE EVENT (No Adverse event) in a 72-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 019H22A) for COVID-19 prophylaxis.     Concurrent medical conditions included Diabetes and Asthma.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 07-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered 13 doses of Moderna COVID-19 Vaccine after more than 30-day use by date). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered 13 doses of Moderna COVID-19 Vaccine after more than 30-day use by date) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (administered 13 doses of Moderna COVID-19 Vaccine after more than 30-day use by date).    No relevant concomitant medications were reported.  No treatment information was provided.
This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (ANTIHISTAMINE ALLERGY RELIEF) and LANSOPRAZOLE for an unknown indication. On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced FATIGUE (Fatigue). At the time of the report, FATIGUE (Fatigue) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication was reported. No treatment medication was reported. This case was linked to MOD-2021-103184.
COMPLAINED OF TONGUE TINGLING, NO SHORTNESS OF BREATH OR SWELLING. NO ITCHING, GIVEN 25 MG DIPHENHYDRAMINE. LEFT IN STABLE CONDITION
Patient passed out and had mild seizure or twitching after receiving BOOSTRIX vaccine. Called 911 everything ok - gave patient food since no breakfast - Left - called him at home 2 hours later - everything ok.
14 yr old patient received lower dose than authorized - received 5-11yr  Comirnaty 0.2ml. in error
Hi I am a travel nurse. I was told to contact you as I had a reaction to the flu shot that I received on Thursday October 5th. Within an hour of receiving the vaccine I felt dizzy and light headed which lasted approx 3 hours. My cheeks, neck and chest became red and hot to touch worsening throughout the day. I had facial swelling (no shortness of breath) and swelling to the hand on the arm I which I received the vaccine. Also the middle and ring fingers on that same hand we're very painful. It took a multiple doses of Benadryl over the next 24 hours for the reaction to subside.
This case was reported by a consumer via out of hour services and described the occurrence of chills in a adult patient who received SHINGRIX for prophylaxis. On 8th August 2018, the patient received the 2nd dose of SHINGRIX. On 8th August 2018, less than a day after receiving SHINGRIX, the patient experienced chills, headache, general body pain and fever. On 10th August 2018, the outcome of the chills, headache, general body pain and fever were recovered/resolved. It was unknown if the reporter considered the chills, headache, general body pain and fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. In the evening of the date of vaccination, the patient experienced chills, headache, fever and achiness as being all over her body.
FEVER OF 101.6 (FEVERISH); ACHY BODY; This spontaneous report received from a patient concerned a 53 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 25-MAY-2021, the subject experienced fever of 101.6 (feverish). On 25-MAY-2021, the subject experienced achy body. Laboratory data included: Body temperature (NR: not provided) 101.6. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever of 101.6 (feverish), and achy body. This report was non-serious.
Cough She did have both of her covid vaccinations but with the symptoms will test.  Hand out given and she is to stay home and self isolate until her test is back Moderate persistent asthma with exacerbation She has using her every day and the albuterol.  She was wheezing in the office.  Could be exacerbated by cold or allergies.  Will place on steroid burst and she is to call with any worsening symptoms or questions or concerns.   Other orders -     predniSONE (DELTASONE) 20 mg tablet; Take 2 tablets (40 mg total) by mouth daily  for 5 days
Blistery rash occurred 10d after 1st dose of SHINGRIX, painful and red on opposite shoulder of injection, lasting 5 days- This is unusual as this is inactive vaccine - when receiving second dose 3 months later, pt had fever and felt sick GI upset and diffuse body aches within hours of the shot and lasted 5 hr.
Started day 5 after vaccine with body ache and low grade temp 99-100 degrees temporal thermometer. Tested for covid  rapid and flu day 6, both negative. Swollen joints started day 6, body ache and swollen joints continued for 5 days, fever lasted 3 days. Went to walk in facility again on day 4 of symptoms, tested flu again, negative. Sent out covid came back negative. Started feeling better day 6 after symptoms started. Felt short of breath for starting day 6 that lasted a week. Missed 1 week of work.
This spontaneous report was received from a medical assistant refers to a patient of unknown age. No medical history was reported. On 19-APR-2013, the patient was inadvertently administered with a single dose of ZOSTAVAX (lot # 672563/1649AA) subcutaneously that had expired on 21-JAN-2013. No concomitant medications were reported. No adverse effects reported. Additional information has been requested.
Patient reported swelling, redness and warm to touch arm below the injection site on the inside of the arm from armpit down to elbow.
red marks around her arm/ red circle around her arm; itchy on left arm; hard lump under the injection site; hives on left arm; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy on left arm), INJECTION SITE MASS (hard lump under the injection site), ERYTHEMA (red marks around her arm/ red circle around her arm) and URTICARIA (hives on left arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included DICLOFENAC (VOLTAREN [DICLOFENAC]) for Knee pain, LEVOTHYROXINE, DILTIAZEM, FAMOTIDINE, CHLORTHALIDONE, POTASSIUM, COLECALCIFEROL (VIT D [COLECALCIFEROL]) and ZINC for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced INJECTION SITE MASS (hard lump under the injection site) and URTICARIA (hives on left arm). On 24-Feb-2021, the patient experienced PRURITUS (itchy on left arm). On an unknown date, the patient experienced ERYTHEMA (red marks around her arm/ red circle around her arm). At the time of the report, PRURITUS (itchy on left arm), INJECTION SITE MASS (hard lump under the injection site), ERYTHEMA (red marks around her arm/ red circle around her arm) and URTICARIA (hives on left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported.  Patient was due for second dose of vaccine on 09-MAR-2021.