chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt recvd 1st dose of Hep B vax & devel h/a which persisted for 2 1/2 days; pt later recovered; pt recvd next 2 doses of Hep B & sx did not recur;
Patient received 0.25mL of Moderna COVID-19 Vaccine, Bivalent.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (Patient received 0.25mL of Moderna COVID-19 Vaccine, Bivalent.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.   No Medical History information was reported.    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) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (Patient received 0.25mL of Moderna COVID-19 Vaccine, Bivalent.) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Patient received 0.25mL of Moderna COVID-19 Vaccine, Bivalent.) 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 UNDERDOSE (Patient received 0.25mL of Moderna COVID-19 Vaccine, Bivalent).    No concomitant medication information was provided.  196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.  It was unknown that the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No treatment medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live follow up received updated patient age group.
Red, hard, warm, swollen area on right deltoid measuring 115mm x 85mm, Child has been chilling, and generally not feeling well per mother. Symptoms started around 2:00 PM 3/29/07. Child has had cool pks and Motrin.
Some reaction, feeling euphoric; High amount of energy; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of euphoric in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number 924E7, expiry date 18-AUG-2024) for prophylaxis.  Previously administered products included Shingrix with an associated reaction of euphoric mood (1st dose was received on 07-FEB-2023 and also she had experienced energy increased, refer case US2023063911).  On 18-APR-2023, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced euphoric (Verbatim: Some reaction, feeling euphoric) and energy increased (Verbatim: High amount of energy). Rechallenge with Shingrix was positive. The outcome of the euphoric and energy increased were unknown.  It was unknown if the reporter considered the euphoric and energy increased to be related to Shingrix.  It was unknown if the company considered the euphoric and energy increased to be related to Shingrix.  Linked case(s) involving the same patient: US2023063911   Additional Information: GSK Receipt Date: 02-MAY-2023 A pharmacist reported that the patient experienced some reaction after the 2nd dose of Shingrix. According to the pharmacist, the patient was feeling euphoric and with high amount of energy after the vaccination. The reporter stated that, same symptoms happened after both the first and second dose. The reporter had consented to follow-up.; Sender's Comments:  US-GSK-US2023063911:Same reporter
This spontaneous report was received from a physician who is also the female patient of unknown age. The patient's medical history, concurrent conditions and drug reactions/allergies. Her concomitant therapies included sterile diluent. On unspecified dates, the patient was vaccinated with the first two doses of M-M-R II as prophylaxis. On an unknown date, she reported that she was later exposed to measles when she cared for two patients from outside the country who had confirmed cases of measles, however, she did not developed measles. On an unknown date, due to exposure concerns she was required to be re-vaccinated with a third dose of M-M-R II. On an unknown date, she was required to have titers drawn which resulted negative for immunity to measles, mumps and rubella. As a result, the patient's facility required her to be re-vaccinated with a fourth dose of M-M-R II. On an unknown date she had titers measured again whiche resulted negative once more. On an unknown date, she received a fifth dose of M-M-R II (Dose, route, lot # and expiration date were not reported for any of the doses given), and this time her titers were drawn again which were positive for immunity to measles, mumps and ruibella. The outcome of measles antibody negative, rubella antibody negative and mumps antibody test negative was reported as recovered on an unknow  date. The reporter did not provide the causality between the events and M-M-R II. This is one of two reports received from the same reporter.; Sender's Comments: 1808USA011297:
Light headedness, 100° temperature,  lethargic, pain at injection site, tight muscles across shoulders & neck
Info. has been received from a registered nurse from an employee health department concerning a 38 y.o. female financial analyst employee w/acne who was vax'd w/her first and 2nd dose of Hep B vax recombinant on 12/3/01 at 8 a.m. and 1/4/02 at 8:00, respectively. Concomitant therapy included one dose of MMRII on 1/11/02 and minocycline HCl (Dynacin), for treatment of her acne. The nurse reported that on an unknown date in 2002 the PT alleged that she had elevated liver enzymes and verbal reports of Lab results from the PT herself revealed elevated serum alanine aminotransferase of 123, elevated serum aspartate aminotransferase of 70, and elevated serum lactate dehydrogenase of 263. The nurse also reported that the "doctor felt she had hepatitis." It was not known why the PT had her liver enzymes tested but it was known that she has had the test done previously related to therapy w/minocycline HCl (Dynacin). The nurse further reported that there was no proof of the elevated liver enzymes at her facility, that the PT was no longer employed there, and that attempts to have follow-up have failed. The PT sought unspecified medical attention. Add'l info is not expected.
itching starting night of 1/15/2021 followed by diffuse hives on 1/16/2021
Body aches, hot and cold flashes, night sweats, rash on left side of neck and upper chest.
Slightly itchy rash  on inside of right arm between hand and elbow - 4 square inch patch
Pt received vaccine at approx. 1410, states she began having tightness in throat and left side of neck and shoulder. Also states she feels shaky and weird
Booster shot requested from a healthcare facility, EMS partner was assisting giving doses to pt.. Gave dose. When shot was to be entered it was found that she had already received her booster about a month prior to the dose given today. Contacted HCF after the 4th dose was found, asked them to watch for increased side effects due to it being the 4th dose.
a rash on a daily basis all day long, rash comes and goes every day, rash is all over the body.; right arm swelled up under the arm pit; This spontaneous case was reported by a consumer and describes the occurrence of RASH (a rash on a daily basis all day long, rash comes and goes every day, rash is all over the body.) and LYMPHADENOPATHY (right arm swelled up under the arm pit) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067F21A, 017B21A and 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced RASH (a rash on a daily basis all day long, rash comes and goes every day, rash is all over the body.). December 2021, the patient experienced LYMPHADENOPATHY (right arm swelled up under the arm pit). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency. In December 2021, LYMPHADENOPATHY (right arm swelled up under the arm pit) had resolved. At the time of the report, RASH (a rash on a daily basis all day long, rash comes and goes every day, rash is all over the body.) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported.  Patient stated that two days after receiving the booster dose, he experienced arm pit swelling under his right arm which lasted for about 24 hours. Two days after the swelling, he had rash which occurred every day all over his body.   This case was linked to MOD-2022-465007, MOD-2022-464998 (Patient Link).
This spontaneous report as received from a medical assistant refers to a unspecified multiple patients. The medical history of unspecified number of patient was unknown. Approximately in June 2014 (last month), unspecified number of patients were vaccinated with PROQUAD (Merck) (dose unit, route, lot# and expiry date unknown) that were improperly stored. No concomitant medications were reported. No adverse effects were reported. The outcome of PROQUAD, was stored improperly and were administered to unspecified number of patients and no adverse effects reported was unknown. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Patient state her arm is warm to the touch with hives around the injection site area, upper arm pain, more pain when moving it
ON DAY OF VACCINATION, NO SYSTEMIC SIDE EFFECTS NOTED.  aPPROXIMATELY 3-4 HOURS POST VACCINATION I DID EXPERIENCE A ORAL DISPLEASENT TASTE OF METAL OR COPPER FOR ABOUT AN HOUR.  THE FOLLOWING SATURDAY JANUARY 23, 2021, I BEGAN FEELING THE SENSATION OF NEED TO ITCH THE ARM OF INNOCULATION.  THROUGHOUT THE DAY I EXPERIENCED THE SENSATION 3-4 TIMES.  LATER THAT EVENING WHEN I DID ASSESSS THE FULL AREA,  THERE WAS A LARGE AREA OF LOCALIZED ALLERGIC (WELT) REACTION WHICH WAS ACUTE.  THE AREA MEASURED 6X3 AND HAD A RAISED, BORDERED EFFEACT THAT WAS WARM TO THE TOUCH AND RED WITHIN THE AREA, WITH A HARD PALPABLE SPOT WHERE THE INNOCULATION OCCURED 1 WEEK PRIOR.  THIS EVENT WAS NOVEL TO THE DATE OF 1/23/2021.  ASSESSMENT DESCRIPTION WOULD APPEAR TO RESEMBLE CELLULITIS,  THE AREA HAD IMPROVED OVER THE COURSE OF 2 DAYS BUT THERE TO DATE IS STILL A SENSATION TO ITCH, AND A CRUSTED SCAB AT THE SITE OF INJECTION.  i AM CONCERNED AS TO WETHER OR NOT i SHOULD RECEIVE MY 2ND DOSE.  i ALSO AM PERSONALLY A VACCINATOR AS WELL AS LOGISTICIAN AT THIS POD FOR THE HEALTH DEPARTMENT  I AM A LICENSED RN.
Atrial Fibrillation Shortness of Breath Fatigue  Eliquis 2.5 mg twice daily
After 12min started to get cold and shake, started to feel so slow even thinking, called my wife on the phone, walked slowly to the counter, and slowly started to have trouble talking, slow talking, neck felt like wierd muscles fighting to move. Then I sat down, monitored by people there. Then after 10 min felt better, but not a 100 percent since then, tierd, muscles. No hospital, Went home.
on 1/6/2022 Pt woke up with Nausea and headache. Pt has week of nausea and headache after dose 2 of moderna the previous year. around 10 am Pt used pulse ox to check HR/O2 due to feeling unwell.  HR was 132 sitting and jumped to 148 when standing. Pt drank fluids and went to lie down. After about an hour of rest hr was 105 laying down, 108 -112 sitting 133 standing  and still had Headache. After remaining up for a while HR stayed at 127 when sitting. Pt called PCP. PCP office advised to go to urgent care. Upon arrival to Urgent care EKG showed Snus Tachycardia with HR 134. Postural testing showed HR of 157 standing.  Fluid given repeated HR done.   Continued Tachycardia on 1/7/2022 and 1/8/2022 at a lower HR.
Patient came into clinic to have PPD read. Mom states both (R) and (L) upper arms red and swollen. Advised to apply ice to sites and RTC if symptom worsen.
pt had t101 & fussy; vomited @ 1AM on 5AUg; 11AM kept down formula but was running temp & crying & fussing; MD @ clinic saw pt 2PM & said did not beleive it was from shots;
pt recvd vax 4DEC92 & devel a sterile abscess which required incision & drainage on 14JAN93; because of pt's obesity reporter feels the pts may have recvd the inject SC; area of induration persists to date of this report;
This spontaneous report received from a patient concerned a 78 year old female. The patient's height, and weight were not reported. The patient's past medical history included ductal carcinoma, and ductal carcinoma surgery, and concurrent conditions included non-smoker, and non-alcohol user, and other pre-existing medical conditions included the patient had no known allergies. The patient had no medical history of drug abuse or illicit drug usage.  The patient was previously treated with lisdexamfetamine mesilate, and vitamins nos. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, intramuscular and batch number: 043A21A expiry: 05-AUG-2021) dose was not reported, administered on 02-JUN-2021 for prophylactic vaccination. Product properly stored from receipt to administration. Concomitant medications included letrozole. On 08-JUN-2021, the subject experienced dry irritated cough. On 08-JUN-2021, the subject experienced sneezy. On 08-JUN-2021, the subject experienced irritated throat. On 08-JUN-2021, the subject experienced dry, raspy and voice changed. On 08-JUN-2021, the subject experienced breathing changed. On 08-JUN-2021, the subject experienced chest irritated and irritation to lungs. On 08-JUN-2021, the subject experienced smell of chemical. On 08-JUN-2021, the subject experienced slight headache.The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dry irritated cough, sneezy, slight headache, irritated throat, dry, raspy and voice changed, breathing changed, chest irritated and irritation to lungs, and smell of chemical. This report was non-serious.
7 cm x 11 cm area of erythema & warmth with mild TTP on (L) shoulder / upper arm.
pain in my chest/stomach; pain in my chest/stomach; she couldn't sleep last night at all she was awake all night; had strange visions flashing in my head while trying to sleep; acid reflux/burping up acid; This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: TL9261, expiration date not provided), via an unspecified route of administration on 25Jan2021 16:30 at a single dose for COVID-19 immunization. The patient has no medical history and there were no concomitant medications. On 25Jan2021, the patient experienced having acid reflux, pain in her chest/stomach that lasted all night last night and was worse when lying down. When she burped, it relieved some pressure. She had strange visions flashing in her head while trying to sleep on 25Jan2021. The patient was wondering if she was having a reaction from the vaccine. On 25Jan2021, after over an hour after the vaccine, she started having severe pain in the chest and stomach area and she couldn't sleep last night at all. She was awake all night, burping up acid. She was wondering if those were reaction to the vaccine, should she go see her doctor or what should she do about that. She got her first dose on 25Jan2021 and she started having chest and stomach pain the same day at about 6 PM. She was burping acid all night and early in the morning of 26Jan2021 and she was having these strange things like pictures going to her head that were weird. She was not sleeping but they were strange images, they were strange, they weren't normal. She says with that added in it sounds crazy. She has her vaccine card that says she should get the next one 15Feb2021. She wanted to avoid catching the corona. She had drank acid yesterday and she was wondering if that was causing her to have acid reflux. She clarified that she drank a lot of acidic liquids on 25Jan2021 and she was wondering if that might have had something to do with it, like orange juice and cranberry juice so she is wondering did that have anything to do with it, the acidity maybe made her stomach have acid reflux because she has had that in the past. She asked if she should go to the doctor. The outcome of the events was unknown.
A report was received from a health care professional on 11/22/02, concerning a group of vaccinees less than 4 years old of unknown demography who inadvertently received Fluvirin from approximately 11/07/02 onwards. There was no reported adverse events. There was insufficient information to determine the reporter's causality assessment. Update (1) 12/10/02: A follow up was received from a health care professional on 12/10/02 indicating that a 18 month old male vaccinee was inadvertently administered Fluvirin intramuscularly on 11/12/02. The vaccinee experienced no adverse event. Cross reference with: PJP200200848, PJP200200849, PJP200200850, PJP200200851, PJP200200852, PJP200200853, PJP200200854, PJP200200855, PJP200200856, PJP200200857, PJP200200858, PJP200200859, PJP200200860, PJP200200861, PJP200200862, PJP200200863, PJP200200864, PJP200200865, PJP200200805, PJP200200867, PJP200200868, PJP200200869, PJP200200870, PJP200200871, PJP200200872, PJP200200873, PJP200200874, PJP200200875, PJP20020876, PJP200200877.
Syncope episodes. 13 in total. 7 with a loss of consciousness to date.  Syncope episodes start with a tunnelling of vision and lack of focus. Mental acuity loss.  Syncope episodes last about 1 minute or less with eye movement and occasional extremity movement.
off label use; Extra dose administered; very tired; she slept all day; This is a spontaneous report from a contactable consumer. This 63-year-old female consumer reported for herself that.  A 63-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: FC3180), dose 3 via an unspecified route of administration on 24Aug2021 16:15 as (At the age of 63-years-old) dose 3, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. No Other Products, Patient History and no Investigation Assessment ware reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: unknown) on 13May2021 and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: unknown) on13May2021. It was reported that patient received extra dose administered (off label use) on an unspecified date. It was reported that Consumer calling regarding the Pfizer booster for COVID 19. Mentions she got the first and second dose and the booster. They wanted her to call in so Pfizer can keep up with what people are having. She is not at home and does not have her other vaccination card but does have information for the booster. When ask to report caller states if she had known it was this big a deal she would not have called. It was reported that patient first dose 13May2021; second dose 03Jun2021. Caller states she doesn't have the card and cannot provide lot number. No NDC, expiration date or dose known to caller. Booster 24Aug2021 at 16:15PM in the left arm; lot FC3180. Caller states there is no other writing on the card for the booster; no NDC, expiration or dose. Administered at doctor's office. Caller reports she was very tired on 25Aug2021; she slept all day. She didn't have that with the first ones. The outcome of events was unknown. No follow up attempts are possible. No further information is expected.
PT. RECEIVED 2 FLU VACCINES IN SAME SEASON ON 9/10/15 & 10/15/15.  PT. WAS ASKED PRIOR TO VACCINATION IF SHE HAD GOTTEN VACCINE THIS YEAR?  PT. STATED NO.  SHE DIDN'T REMEMBER GETTING VACCINE OVER 4 WEEKS AGO.  THIS PT. DID NOT HAVE ANY SYMPTOMS OR COMPLICATIONS @ TIME OF VISIT AND HAS NOT REPORTED ANY TO DATE.
covid vaccine breakthrough event  dose 1 3/31/21 Pfizer ER8730 dose 2 4/21/21 Pfizer EW0162
Pzifer contacted, vaccine dilution error.  Patient contacted  had not adverse event at the time of reporting.
Bilateral weakness from knees down.  Numbness and tingling progressed to hands. 12/16/22 presented to Hospital with symptoms. Reported having upper respiratory infection 1 week prior.
Headache,  runny/stuffy nose, muscle aches, chills, low grade fever and loose stool.
Onset of low grade fever 99.7 - 100. 9 for 7 days. Diarrhea.  Loss at appetite.
measles type of rxn-rash, nausea, diarrhea, lymphadenopathy, fever, myalgias;
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NUS2022US071662. A 64-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 64 years for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunization. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "he got the covid booster and it 'knocked me out for a few days.". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
J18.9 - Pneumonia, unspecified organism N17.9 - Acute kidney failure, unspecified I21.4 - NSTEMI (non-ST elevated myocardial infarction) (CMS/HCC)
Within minutes of receiving flu shot, soreness/pain at injection site. Within 20 min, pain extended to elbow. < 2hrs, entire arm in a lot of pain. Pain continued, although easing. Started losing mobility. 3 1/2 months later, arm still painful, mostly around injection site, and loss of mobility. Treatments: Dr. visits, X-ray (negative), physical therapy (stopped per Dr orders), blood test. Has impacted everyday life (dressing, washing, reaching, etc).
Patient presented today with rash on neck. She said it was very similar to her shingles outbreak last April. It is red itchy patches. Most likely triggered dorment virus to become active. Patient is following up with PCP for treatment options.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2009, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 10-JAN-2015, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events is unknown. Additional information has been requested.
patient woke up this am at 9:00 with swelling to left side of face near jaw line.  Came to clinic to see Dr., states swelling down from 3 hours ago.  Had Menactra vaccine at 9:30am on 10/25/07