chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a nurse sales rep and described the occurrence of felt faint in a 16-year-old female patient who received BEXSERO. Co-suspect products included Hepatitis A vaccine and MENACTRA. On 1st September 2016, the patient received BEXSERO (intramuscular), Hepatitis A vaccine and MENACTRA. On 1st September 2016, less than a day after receiving BEXSERO and Hepatitis A vaccine, the patient experienced felt faint. On an unknown date, the outcome of the felt faint was not recovered/not resolved.  It was unknown if the reporter considered the felt faint to be related to BEXSERO and Hepatitis A vaccine. Additional details were provided as follows: the patient received BEXSERO and Hepatitis A vaccines on her arm. the patient also received a dose of MENACTRA concomitantly on her arm. the patient felt like fainting after vaccination. the manufacturer of co-suspect vaccine Hepatitis A was unknown. the lot number and expiration date of the vaccines were unknown. the sales representative noted that the office had files a VAERS report. This case has been linked with US2016128111 (twin's case), reported by the same reporter.
pt recv vax & pt exp MS;the pharmacist reported three patients;they were assigned WAES96051400 through 96051402;
REDNESS AT SITE BEGAN ON RIGHT UPPER ARM AND AREA CONTINUED TO INCREASE IN SIZE TO APPROXIMATELY SIZE OF EGG WITH A SMALL KNOT FELT UNDER SKIN IN SQ TISSUE.
The vaccine vial was opened on 11-Aug-2021. The vial was never removed from the refrigerator after that day and wasted/disposed of. The vial was accidently used for vaccines given on 20-Aug-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vaccine vial was opened on 11-Aug-2021. The vial was never removed from the refrigerator after that day and wasted/disposed of.  The vial was accidently used for vaccines given on 20-Aug-2021) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025C21A, 002C21A and 002C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 28-Dec-2020 and Kidney transplant on 01-Feb-2013.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (The vaccine vial was opened on 11-Aug-2021. The vial was never removed from the refrigerator after that day and wasted/disposed of.  The vial was accidently used for vaccines given on 20-Aug-2021). On 20-Aug-2021, EXPIRED PRODUCT ADMINISTERED (The vaccine vial was opened on 11-Aug-2021. The vial was never removed from the refrigerator after that day and wasted/disposed of.  The vial was accidently used for vaccines given on 20-Aug-2021) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Dec-2020, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was administered expired covid vaccine. The vaccine vial was opened on 11-Aug-2021 and one dose was given to a patient.  The vial was never removed from the refrigerator after that day and wasted/disposed of.  The vial was accidently used for vaccines given on 20-Aug-2021. This was the patient's booster of covid vaccine.  No relevant concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-Sep-2021: Follow-up information included patient details, medical history, lab data and vaccine administration details.
everything is shift on left side of my body and I am feeling this pretty much since I would say the second day of the Vaccine but pain has been more afterwards; feel the pain going from my shoulder, the top of my shoulder towards my neck it gets around my collar area; pain I would say shoulder cup area in the back and on the mid back area where that shoulder was going; pain, I would say around my shoulder cup area, I would say the cup area, sometimes its there, sometimes like the pain was running down my from shoulder cup area down my arm towards my wrist/felt it in my left hip; sore arm/I am feeling pain in my thigh area and in the back of my thigh/have feel the pain in the top of my hand and just to the back of my hand from around my finger bone area to the middle left; This is a spontaneous report via Pfizer-sponsored program from a contactable consumer (patient). A 30-year-old patient of an unspecified gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-119 VACCINE, Solution for injection, Lot Number: EW0185), intramuscularly on 22May2021 16:30 as 1st dose, single dose in left arm (on left shoulder as reported) for COVID-19 immunisation at pharmacy. Patient didn't receive any other vaccinations within 4weeks. Medical history included ongoing blood pressure measurement (takes Amlodipine 5mg to control blood pressure). Concomitant medications included amlodipine at 5 mg taken for blood pressure. It was reported that when I got the vaccine I had the normal side effect which was the sore arm which, I received like 12 hours later and it lasted for 25 hours but its been, I had the vaccine administered on 22nd and since then pretty much I have been having pain, I would say around my shoulder cup area, I would say the cup area, sometimes its there, sometimes like the pain was running down my from shoulder cup area down my arm towards my wrist. And sometimes I have feel the pain in the top of my hand and just to the back of my hand from around my finger bone area to the middle left and if I say feel the pain going from my shoulder, the top of my shoulder towards my neck it gets around my collar area. Then sometimes I am feeling pain I would say shoulder cup area in the back and on the mid back area where that shoulder was going. I would say I am feeling pain in my thigh area and in the back of my thigh, worried about my knee and the back of my thigh. Sometimes I feel it down and I also felt it in my left hip all on 22May2021. So everything was shift on left side of my body and I am feeling this pretty much since I would say the second day of the Vaccine but pain has been more afterwards." Therapeutic measures were taken for the adverse events was Tylenol. The outcome of the events was unknown.  Information about batch number has been requested.
Reported pain, swelling, and erythema LUE at injection site. Exam revealed blanching erythemic patch with diffuse borders.  Advised follow up with PCP for assessment.
Two Hibs given on the same day - one separately and one included in the PENTACEL.
shots were not so hot; This case was reported by a consumer via interactive digital media and described the occurrence of injection site warmth in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site warmth. On an unknown date, the outcome of the injection site warmth was unknown.   It was unknown if the reporter considered the injection site warmth to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient. The age at vaccination was not reported. The shots were not so hot.  For tolerance of 2nd dose, refer case US2021AMR263517. The follow-up would not be possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR263517:same reporter
Started to develop palpitations in March 2021.  Went for a cardiac stress test in June 2021 which showed SVT.  The SVT lasted about 10 beats and would recur.  There would be 5 or more episodes per min.  SVT and PAC continues to this day.  Occurs daily every minute.
Information has been received from a physician concerning a male (age not given), who was vaccinated on an unknown date with a dose of MMR vaccine live (second generation) (lot # not given). At the time of vaccination the patient had an unknown immune deficiency. Following vaccination, the patient developed a morbilliform rash and fever, got better, then developed another morbilliform rash and fever for 3-4 days, the a serious illness. The patient had been diagnosed on an unknown date with hematophagocytic syndrome, and Epstein Barr virus was found. The patient had also been hospitalized on an unknown date. The patient died (cause unknown) on an unknown date. It was noted that this case took place some years ago, and had to do with a child. Morbilliform rash, fever, serious illness, hematophagocytic syndrome, Epstein Barr virus and the unknown cause of death were considered to be immediately life-threatening. Additional information has been requested.
Nausea, sweating, dizziness.  Low blood pressure and actually passed out and 911 called. Malaise and tiredness
pt reported in person to clinic; on lt arm there was a 3x5 cm hard, red, raised knot, hot to touch, stated woke up 27FEB93 w/lt arm itching & rash only @ inject site & stated hardened area was approx 4" in diameter; dx cellulitis;
Allergic arm rxn - 12cm of induration, swelling, erythema lt arm, fever;
This spontaneous report was received from the patients grandmother refers to a 12 year old female patient. The patient who had been menstruating for "about two years" normally has "very heavy" periods. Shortly after the GARDASIL (lot # expiry not reported) was administered on an unknown date in July 2013 (reported as mid July) the patient experienced a usual, normal menstrual period. On an unknown date in August 2013 the patient experienced only "a few days of spotting" and felt "bloated". Her period was much shorter and lighter than normal. No treatment was given to the patient. No medical attention sought. The outcome of felt bloated, her  period was much shorter and lighter than normal and a few days of spotting was unknown. Additional information is not expected.
Swollen and painful lymph node under left armpit beginning 2 days after booster administration
flaming red cheeks, hot spots appeared over weekend;total body rash, itchy;MD told mom to give DPH, itchy stopped, rash is subsiding;
Trouble breathing, SOB, increased BP. Admitted to ICU 4 days after vaccine.
This spontaneous report as received from a Community Nurse Practitioner refers to a patient of unknown age. On 26-APR-2013 the patient was vaccinated with a dose of GARDASIL (lot# not reported), intramuscularly. The nurse practitioner noted that the patient was administered a dose of CERVARIX on 26-OCT-2012 and another dose of CERVARIX on 26-NOV-2012. The patient was administered a dose of GARDASIL today (26-APR-2013). No adverse effect was reported. Additional information has been requested.
Since vaccination have felt lethargic, dizzy, have passed out, rapid heart palpitations, clamminess.
Exhibited Premature Ventricular Contractions starting end of April and it continues presently
diarrhea; stomach cramping; sore throat; running a temperature; lymph node in right arm same side as shot is swollen the size of goose egg; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: FD8448, Expiration date: 31Oct2021) via an unspecified route of administration, administered in arm right on 04Sep2021 13:00 (age at vaccination: 46-years-old) as dose 1, single for COVID-19 immunization. The patient medical history included both herself and her husband had a pretty heavy case of covid-19 in Mar2020. Relevant medical history and concomitant medications included none. On 04Sep2021, the patient had experienced running a temperature, lymph node in right arm same side as shot was swollen to the size of goose egg, diarrhea, stomach cramping and sore throat. The patient underwent lab tests and procedures which included sars-cov-2 test: covid-19 in Mar2020; body temperature: 99.8 on 04Sep2021, and on unknown date in 2021 it was 101.3-101.8. Therapeutic measures were taken as a result of running a temperature, lymph node in right arm same side as shot was swollen to the size of goose egg, diarrhea, stomach cramping, sore throat and included Tylenol and Imodium. The outcome of the event running a temperature was recovering and other events was not recovered.
This report described the occurrence of sudden infant death syndrome in a two month old female pt who received DTaP and hep B vaccine for prophyalxis. This report was received from the pt's mother and has not been verified by a physician or other health care professional. The pt's medical history, concurrent conditions, and concurrent medications were not reported; however, the reporter stated that a younger sibling had "severe sleep apnea." The reporter stated that the pt received the first dose of hep B vaccine at the time of birth without incident. On 8/28/02, the pt received the first dose of DTaP and second dose of hep B vaccine. On the same date, the pt also received injections of IPOL, and HIB vaccines. Approximately 72 hrs post-immunization, on 8/31/02, the pt died at her residence. The reporter stated that the autopsy indicated that the pt had died due to SIDS. Additional info has been rerquested.
Adverse reaction to VARICELLA vaccine - Developed vesicular rash at injection site with surrounding cellulitic changes started on antibiotic therapy 11-12-09.
Her husband got a heart attack a week after the first dose; there are blood clots on his legs; This is a spontaneous report from a Pfizer-sponsored program. A male patient of an unspecified age received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 24Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter stated that her husband got a heart attack a week after the first dose and there are blood clots on his legs on an unspecified date. Outcome of the events was unknown.   Information on the Lot/Batch number has been requested.
Pt had verified seizure after a vaccine for meningitis and HPV. The seizure was brief - about 2 min and was accompanied by shaking and stiff limbs, incontinence and a bitten tongue..heart rate was never low. His seizure occurred roughly about 1-2 min after the injection.  He has dilated pupils afterwards. We kept him for 25 min after his seizure cleared and he was normal on exam before he left.
Initial report received from a health care professional on 03 December 2008. A 60-year-old male patient received a left deltoid injection of FLUZONE SV 2008-2009 (lot number U2764AA, route of administration not reported) on 20 November 2008. The patient started having flu-like symptoms of generalized achiness and congestion that evening (onset date of events was also reported as 21 November 2008). The patient then developed chest pain that worsened over the next two-to-three days, sending the patient to the emergency room for treatment. The patient was admitted to the hospital three days after receiving FLUZONE. Length of hospitalization was also reported as three days. The patient underwent an EKG, Stress Echo and lab work of cardiac enzymes and was diagnosed with pericarditis. Treatment during hospitalization was not reported. Patient outcome was reported to be unknown. Documents held by sender: None.
Injection site is now approximately the size of a baseball; Taste and smell just started to return; Taste and smell just started to return; Fever; Muscle spasms; Chills; Nausea; Headaches; Heart felt like it was skipping around, pounding; Heart felt like it was skipping around, pounding; Left arm has been expanding since the injection/Tightness in the left arm; Quarter size red area around the injection site; Case reference number MOD-2021-018713 is a spontaneous case report sent by a Non-Health Professional on 19-FEB-2021 00:00:00 , which refers to a Female aged 30 Years .  The patients past medical history included: Food allergy    , COVID-19 31-JAN-2021. The patient had a history of allergy to: Egg allergy .  The patient was administered the first dose of Moderna COVID-19 Vaccine for COVID-19 vaccination on 17FE2021 on her left arm.. Some  1 day later,  the patient developed Vaccination site erythema. Over a period of the next days, the patient also developed Smell loss,Fever,Muscle spasms,Chills,Nausea,Headache,Skipped beats,Heart pounding,Vaccination site swelling,Vaccination site induration,Taste loss.  The patient was treated for the event with  Ibuprofen.   The medical reviewer may provide a case evaluation statement, including other possible etiological and confounding factors, e.g. (only limited information has been obtained so far, it is difficult to assess the cause and effect relationship  Follow-up Required.  Terse Narrative (for PSUR narratives and signal review) Brief 3 line summary of above for CIOMS listing: Report Source- Non-Health Professional,  Age- 30 Years,  Sex- Female,  Suspect Drug- Moderna COVID-19 Vaccine,  Treatment-    Diagnosis\Outcome- Quarter size red area around the injection site - Unknown,Taste and smell just started to return - Unknown,Injection site is now approximately the size of a baseball - Unknown,Left arm has been expanding since the injection/Tightness in the left arm - Unknown,Heart felt like it was skipping around, pounding - Unknown,Heart felt like it was skipping around, pounding - Unknown,Headaches - Unknown,Nausea - Unknown,Chills - Unknown,Muscle spasms - Unknown,Fever - Unknown,Taste and smell just started to return - Unknown.
I inquired if he had received his Moderna Bivalent vaccine and he stated no. Only the previous Moderna series with the two boosters. Offered the Moderna Bivalent vaccine and he accepted. After Vaccine was administered, I gave him his vaccine card and he pulled out another card showing he had already received the bivalent vaccine in September. The doctor on site was notified.
Patient Under the age of 18 was inadvertently given Moderna instead of Pfizer vaccine.
I received the vaccine on March 24, on a Blue Day, when I was physically at work.  I stayed in the office until 5:00 pm and felt normal.  I could feel the place of the injection, but that was all.   The next day, March 25, I worked from home.  I woke up with a medium pain in the arm at the place of the injection and with a headache.  I said to myself, these are normal reactions following the vaccine.  The headache did not go away, although I took a Ibuprofen rapid tablet of 400 mg.  In the afternoon I checked my blood pressure and it was 171/90 and the pulse 86.  I took immediately additional blood pressure medicine (Captopril and Tertensif) to lower it.  In 2 hours it lowered it to 166/89 P81, at the advice of my physician, whom I called, I took the medicine I take for blood pressure Atacand and a pill to eliminate the water in the body.  Finally at 9:00 pm the blood pressure measured 149/81 P71.   On March 26 I came to work, with my blood pressure device, and at noon it was 198/94 P95.  I took two pills of Atacand and Furosemid and I came to the physician measured a blood pressure of 159/95, and subsequently 144/86.  She did an EKG which was normal.   On March 27, Saturday the blood pressure ranged between 132/74 P72 in the morning and 104/60 P 65 in the evening, taking only my usual medication for blood pressure.  And since then my blood pressure returned to normal taking only my usual treatment.      On March 29 I went to my cardiologist who examined me and did not find anything out of the ordinary, told me to continue with the same treatment, and monitor the blood pressure twice a day.  She of course, as anyone else, could not say it was due to the vaccine, but she could not dismiss the fact that maybe the vaccine had an influence over the blood pressure.  She encouraged me to take also the second dose of the vaccine.
In October the numbness and tingling started on the left side on the nerve area. I called my doctor last week. I had appointment with my primary and he prescribed me Lyrica. He said to try that for the nerve pain.
This patient had a red swollen patch 1" wide by 2" across, heat and pain in area; shortness of breath, paleness. The physician stated 1 1/2 " wide by 3" across, local not systemic.
Covid Arm-red rash, itchy, warm to touch on arm where the vacine was administered.
VERY SORE ARM 12 HOURS AFTER SHOT: CHILLS AND FEVER OF 99.1; SENSITIVE SKIN RASH; ACHY JOINTS; TIRED.
This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered 2 booster doses (1 to each patient) to 2 patients who were less than then age of 18 years/Less than 18 years of age) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051F21A) for COVID-19 vaccination. No Medical History information was reported. On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Nov-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered 2 booster doses (1 to each patient) to 2 patients who were less than then age of 18 years/Less than 18 years of age). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered 2 booster doses (1 to each patient) to 2 patients who were less than then age of 18 years/Less than 18 years of age) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No Concomitant informations were reported.No Treatment informations were reported.
Woke up 1am with extreme headache crown of head. Chills, nausea. Weak limbs. Barely made it to bathroom, had dhiarrhea. Fainted on bathroom floor. After about an hour was able to get back into bed. Shivering with 100 fever for 3 hours. Loud ringing in ears. Was blacking out. Still sick but the fainting and extreme episode at 1am seemed worth reporting and extreme