chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vaccination in a pregnant woman with no adverse event; Initial information received on 04-Dec-2020 regarding an unsolicited valid non-serious case received from a healthcare professional (patient).  This case involved an unknown age female patient who received INFLUENZA VACCINE while she was pregnant with no adverse event (Exposure during pregnancy).  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. She was exposed to INFLUENZA VACCINE at an unknown gestation period.  The date of last menstrual period was not reported.  The estimated due date was not reported.  Medical history, medical treatments, vaccinations, concomitant medications and family history, were not provided.  Information regarding current pregnancy history was not reported.  Information regarding previous pregnancy was not reported.  Information regarding maternal drug exposure was not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) (lot number not reported) via unknown route at an unknown administration site as prophylactic vaccination.  Information regarding pregnancy complication was not reported.  It was not reported if infertility treatment was given or not.  Information regarding family history of congenital abnormality was not reported.  Information regarding prenatal testing was not reported.  At time of reporting, the pregnancy was still ongoing.  Information on the batch number was requested.
Pt recvd vax 26JUN92 & 26JUN92  exp soreness @ the inject site; exp nausea; face seemed warm to touch; devel large, blotchy patches accompanied by hives; facial flushing, h/a & photosensitivity;
a 72 year old male received a dose of fluzone quadrivalent in error instead of fluzone high dose/No AE; Initial information received on 03-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 72 years old male patient who received a dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] in error instead of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot number and expiry date not reported via unknown route in unknown administration site on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to wrong vaccine administered.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  List of documents held by sender: none.
had asymptomatic COVID test as had placement identified. COVID test returned positive so placement is on hold.  He reports no symptoms and is hopeful he can leave the hospital soon.
herpes zoster about 5 years after completing the 2 dose series / Suspected vaccination failure; herpes zoster about 5 years after completing the 2 dose series; neuropathic pain for the past 4 months/ The neuropathic pain has not resolved, but is manageable by reporter; vesicular rash on a dermatome in his back; This serious case was reported by a pharmacist via sales rep and described the occurrence of vaccination failure in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.  Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.  On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, 5 years after receiving Shingrix and more than 2 years after receiving Shingrix, the patient experienced vaccination failure (Verbatim: herpes zoster about 5 years after completing the 2 dose series / Suspected vaccination failure) (serious criteria GSK medically significant), herpes zoster (Verbatim: herpes zoster about 5 years after completing the 2 dose series), vesicular rash (Verbatim: vesicular rash on a dermatome in his back) and post herpetic neuralgia (Verbatim: neuropathic pain for the past 4 months/ The neuropathic pain has not resolved, but is manageable by reporter). The outcome of the vaccination failure was unknown and the outcome of the herpes zoster was not reported and the outcome of the vesicular rash was resolved (duration 4 weeks) and the outcome of the post herpetic neuralgia was not resolved.  It was unknown if the reporter considered the vaccination failure, herpes zoster, vesicular rash and post herpetic neuralgia to be related to Shingrix and Shingrix.  It was unknown if the company considered the vaccination failure, herpes zoster, vesicular rash and post herpetic neuralgia to be related to Shingrix and Shingrix.  Additional Information: GSK Receipt Date: 22-MAY-2023 The reporter was a PharmD. The reporter thought that the patient received the Shingrix about 5 years ago (2017-2018). The pharmacist had reported that, the patient was getting a herpes zoster about 5 years after completing the 2 doses series. He reported a vesicular rash on a dermatome in his back. He did not seek care for the rash from his Primary care physician (PCP). The rash had resolved after 4 weeks. He reported neuropathic pain for the past 4 months.  He had taken over the counter (OTC) pain medicine but did not seek further care.  He reported not being on any immunosuppressive meds or any awareness of compromising conditions.  The neuropathic pain had not resolved but was manageable by reporter. He said it did not stop him from his normal activities. The reporter had denied consent to follow-up.  This case was considered as suspected vaccination failure as detail regarding laboratory test confirming shingles were unknown at the time of reporting.
Patient presented to nurse A&O x3, with calm affect.  No history of reactions to vaccines.  After prescreening patient the vaccine was given.  Immediately, the patients eyes rolled back and he went limp. RN supported patient in chair until paramedic took over quickly..
My primary dr but I received vaccines via pharmacy.     4/2nd 1st vaccine: nausea, light headache & extreme fatigue. I fell asleep several hrs after I got it & was fatigued the next day. Additionally, began to feel jittery/clumsy w/ my fingers, eye twitching, some shooting pains on the legs, some vertigo. The jitters stayed for about a wk or so, eye twitching was bad & I felt a little anxiety ridden/panic attack like. After 4 wks passed, eye twitching had lessened, vision kept changing thruout this time & jitters seemed to be gone. Interesting, I had not had a menstrual cycle in many months but had one 3 - 4 weeks after vaccine.     5/2nd 2nd vaccine: I was a little tired the 1st day. Two days later, I was hit with fatigue, jitters, eye twitching too but lighter version. Along w/fatigue, I didn't feel like myself & felt anxious & short.  I started to have internal vibrations/shaking of tingling toes/fingers/abdomen/vaginal area - light burning too. Recently, a little on my left shoulder. As well, I had some highly infrequent but sharp, painful aching pains in foot area. Last 3 days I feel like my energy is up again, like myself. Vibrations & eye/vision issues continue though not as bad. I hope it all resolves and I continued in this better state.  I do hope to get back to 100% though.  This has all been concerning.
Vomit (only once), and then she was fine afterwards.  Normal color/mood/appetite/etc. shortly after vomiting.
pt recv vax & pt exp swelling of hands, bone crushing pain in pelvic area, flu like sx w/diarrhea, stiff neck, severe joint, pain in elbow, knee, shoulder & ankles;joint pain;
No adverse effects reported; was given ZOSTAVAX instead of VARIVAX second dose on 3/28/2019 inadvertently; This spontaneous report was received from a registered nurse referring to a patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not provided.     On 28-MAR-2019, the patient was inadvertently vaccinated with a dose of zoster vaccine live(ZOSTAVAX) (lot# reported as N028855 expiration date 13-JAN-2019 (also reported as 13-JAN-2020); route was not provided) instead of the second dose of varicella virus vaccine live (Oka/Merck)(VARIVAX); for prohylaxis. However, the reporting nurse stated that there was no product confusion. No adverse effects were reported.
This spontaneous report was received from a pharmacist via company representative referring to a 66 year old female patient. The patient's pertinent medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (anatomical route of vaccination, dose number, lot number and expiration date were not provided). The patient's concomitant medications were not reported. On an unknown date, the patient had a significant swelling from her elbow to her shoulder, also described as "illness at the time of vaccination" (conflicting information). Due to it, the patient required medical intervention to prevent any serious outcome. It was also reported that the patient was not prescribed with drug treatment for peripheral swelling, that the patient was not hospitalized and that peripheral swelling was not life threatening or significant disability. At the time of the report, the outcome of peripheral swelling was reported as recovered on an unknown date. The relatedness between the adverse event and vaccination with PNEUMOVAX 23 was not provided. Additional information is not expected as all information has been received to complete the case.
Cough, sore throat, extreme shortness of breath, slight dizziness, small headache, wheezing, congestive heart failure, heart attack. Was hospitalized Friday 10/15/10. Thursday 10/14/10 had cough, sore throat, hoarseness. They treated me for congestive heart failure and heart attack and pneumonia.
No additional AE reported; PROQUAD was inadvertently administered to the following patient after its labeled expiry date.; This spontaneous report was received from a nurse referring to a 6-year-old female patient. The patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies were not reported.  On 28-APR-2023, the patient was inadvertently vaccinated with expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin [rhA]) (PROQUAD) injection, lot #U029321, expiration date: 19-MAR-2023, administered for prophylaxis (strength, dose, and route of administration were not provided) (Expired product administered). The vaccine had not undergone any temperature excursions. No additional AE reported (No adverse event).  This is one of three reports received from the same reporter.
COVID-19 Symptoms; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19 Symptoms) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19 Symptoms). At the time of the report, COVID-19 (COVID-19 Symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medication was reported.   This case was linked to MOD-2021-046034 (Patient Link).
Drug ineffective; COVID-19; Sickness; ALLERGIES; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. Other Case identifier(s): 22K-163-4327620-00.  A 10 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 16Nov2021 (Batch/Lot number: unknown) at the age of 10 years as dose 1, single and intramuscular, administration date 15Dec2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at unk (citrate free). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SUSPECTED COVID-19 (medically significant), outcome "not recovered", described as "COVID-19"; DRUG INEFFECTIVE (medically significant), outcome "not recovered", described as "Drug ineffective"; ILLNESS (non-serious), outcome "unknown", described as "Sickness"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "ALLERGIES". The action taken for adalimumab was unknown.  The reporter's causality for the event(s) of Sickness (Illness) was reported as Possible and COVID-19 (COVID-19), Allergy  (Hypersensitivity)  Causality as per reporter (Drug/Vaccine):  Not Reported  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the Limited information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events. The case will be reassessed once new information is available.
This concerns a pt who was vaccinated with pneumococcal vaccine 23 polyvalent and influenza vaccine on 11/14/2000 on the opposite arm. On 11/15/2000 the arm was very swollen with red half dollar size raised area directly at site of injection. The pt had difficulty raising her arm due to muscle soreness. The nurse informed the pt to apply cold and take Benadryl or Actifed and to call if there was any additional problems.
In the morning I had fatigue for 3 days; minor runny nose; slight scratchy throat and low grade fever. I did a tele health on 07/22/2022 Friday with my the doctor who prescribed me PAXLOVID for 5 days. I had experienced a severe metallic taste from the medication. I tested negative for COVID-19 on 07/29/2022.
Within about 20-25 minutes of receiving my 1st dose, I started to get flushed from my neck up through my forehead and my face was BRIGHT red and my cheeks were very warm to the touch.  The whole reaction lasted no more than 30-minutes.
Father presented to ER for daughter having upper respiratory/flu-like symptoms.  Adds "I lied about my daughter's age so that she could receive a dose of the COVID Pfizer vaccine last week."
Received 2nd dose of Children's Pfizer vaccine on 12/10/2021.   On 12/14/2021 began c/o chest pain and feeling like heart was jumping while at school.   School nurse reportedly checked VS and they were stable.   Seen in our office 12/15/2021 and reported this to us.   EKG ordered.   Pediatric ECG analysis reads "normal sinus rhythm - ST Elevation Consistent with injury, pericarditis or early repolarization".   Referred to cardiology for consult. Clinically she was no longer symptomatic when seen by physician on 12/15/2021.   Awaiting consult report from pediatric cardiology.
Covid19 breakthrough.  1st vaccine received on 02/13/2021.  73 y/o PMH CVA secondary to carotid artery stenosis (s/p Right CEA 1/10/2022), COPD, DVT, Fibromyalgia, HTN, HLS, OSA, PVD, Seizures, dementia presents to ED with increased weakness, confusion, chronic cough and chronic nausea.  Husband called EMS with concern for stroke symptoms due to increased lethargy and being uncoordinated. Pt found hypotensive, room air sats 85%, placed on O2 2LNC. CXR interstitial/alveolar densities.  CT brain neg.  Started on IV ABX.
Stomach pain, loss of vision/ hearing-daily since shots "black out"/"seizure" activity, slight temp, skin cold to touch, clammy. Had this 8/6/10 and 8/17/10 with vision and hearing loss.
A 65 year old male patient received a 0.5 ml dose of a pneumococcal vaccine in the right lateral thigh during an INS physical on 05/02/2005. On 05/03/2005 he experienced hardness, pain and redness at the injection site and also a fever.
Pfizer covid vaccine administered after syringe was left at room temperature for approximately 21 hours.
Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. On unspecified dates, the patients were vaccinated with an unspecified number of improperly stored doses of GARDASIL 9 (lot # L007560, expiration date 15-JUN-2017, lot # L013429, expiration date 21-JUL-2017, route not provided. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
The evening of the vax, the pt complained of shortness of breath and requested use of inhaler. The pt's husband noted little or no relief. The pt was then transferred to bed from her motorized cart. the husband observed her to stare at the ceiling for approximately 20 seconds. She became frightened and asked him to get help. A neighbor (who happens to be a Pulmonologist) was called. He found the pt with "no sinus rhythm" and was unable to resuscitate her. There was no evidence of bronchospasm, no hives, and no report of audible wheezing. The death certificate lists "Pulmonary arrest" as cause of death. Reporting MD and Pulmonologist suspect pulmonary embolus as exact cause of death. Additional information has been requested. Follow up report received 11/07/2000: One of 2 spontaneous reports received from a physician, regarding possible adverse events associated with uses of Fluvirin, lot # H66340HA.  A 55 year old morbidly obese female (weight > 350 pounds), with a history of diabetes with diabetic neuropathics, possible transverse myelitis (recent development of neurogenic bladder control problems), and mild asthma, (requiring recent increased use of her inhalers), received vaccination with Fluvirin in October 2000.  Later that evening, patient complained of shortness of breath and requested use of inhaler.  Husband noted little or no relief.  Patient was then transferred to bed, from her motorized cart.  Husband observed her to stare at the ceiling for approximately 20 seconds.  She becaem frightened and asked him to get help.  A neighor (who happens to be a Pulmonologist) was called.  He found patient with no sinus rhythm and was unable to resuscitate her.  There was no evidence of bronchospasm, no hives, and no report of audible wheezing.  The death certificate lists "Pulmonary arrest" as cause of death.  Reporting MD and Pulmonologist suspect pulmonary embolus as exact cause of death.  Follow up information received, November 1, 2000 from the primary care physician.  Medical history significant for hypothyroidism, and allergies to penicillin, rvp dye, shellfish, and Tegretol.
STARTED WITH STOMACH ACHE FOLLOWED BY VOMITING.  PT VOMITED EVERY 1-1.5 HOURS THROUGH THE NIGHT, ONCE IN THE MORNING, FOR A TOTAL OF 5-6 VOMITING EPISODES.  LAST EPISODE WAS AT 9:30 AM. FEVER BEGAN IN THE MORNING. ORAL INTAKED INCLUDED WATER UNTIL 9:30AM AND THEN PT STARTED 5ML GATORADE EVERY 5 MINUTES.  PT SEEN IN THE OFFICE WHERE EXAM WAS NORMAL WITH THE EXCEPTION OF SWOLLEN AND ERYTHEMATOUS TONSILS AND ENLARGED ANTERIOR CERVICAL LYMPH NODES. A RAPID STREP TEST WAS PERFORMED AND RESULTED AS NEGATIVE. THE BACK-UP CULTURE WAS ALSO NEGATIVE.  PT GIVEN 1 TSP OF CHILDREN'S TYLENOL AND ZOFRAN 4MG ODT IN OFFICE AND ADVISED TO CONTINUE ANTIPYRETICS AS NEEDED FOR FEVER AND/OR PAIN. ENCOURAGE ORAL FLUIDS AND ADVISED TO CALL BACK WITH NEW/WORSENING SIGNS OR SYMPTOMS.
Nausea and dizziness starting around 24 hours after the injection, followed by chills and diarrhea.  I took one imodium, but threw it up almost immediately.  Took another one mid day and it stayed down and stopped the diarrhea.  I vomited three times yesterday, but hadn't eaten anything to speak of.  Drank only water.  No fever until this morning, 48 hours after the injection, when I had a fever of 99.5, about 2 degrees more than usual.  still nauseous and dizzy, but not as bad as yesterday.  Have not thrown up nor have I had any bouts of diarrhea.  I called my doctor, and she said it could be as long as three days, so I'm just sipping water and hoping for the best.
injection site pain; scheduled to get my 2nd dose of the Pfizer Covid vaccine today, I am currently 19 weeks pregnant; This is a spontaneous report from a contactable pharmacist (patient). This is a maternal report. A 38-year-old pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN5318), via intramuscular, administered in deltoid on 12Feb2021 afternoon (at the age of 38-year-old) as dose 1, single for COVID-19 immunization. Medical history included seasonal asthma, obstetrical history included 3 previous pregnancies and 1 other child. She had 2 miscarriages/2 live births (one of the live births was preterm). Concomitant medications included Prenatal vitamins (capsules) for pregnancy at the frequency of once a day, orally from Dec2020 and ongoing and acetylsalicylic acid (ASPIRIN) 81mg tablet taken for pregnancy from Dec2020 to Jul2021. The patient had no prior vaccination. The patient was pregnant at the time of vaccination. The last menstrual period date was on an unknown date Oct2020 and estimated date of conception was in Nov2020. On 12Feb2021, the patient experienced injection site pain. The mother reported she became pregnant while taking bnt162b2. The mother was 19 Weeks pregnant at the onset of the event. The mother was not smoking, drink alcohol or used illicit drugs during pregnancy. The mother delivered the pregnancy via cesarean delivery. The baby was delivered full-term. Gestational age at birth was 39 weeks 4 days. The baby weighed 2721grams. APGAR Score 1 was 9, APGAR Score 2 was not provided, APGAR Score 3 was not provided. The fetal outcome is normal. Neonatal Information- Infant Details: Gender: Female Weight at birth: 6 lbs 7 oz Length at birth: 19 in Head circumstance at birth: 34cm. The patient did not have any problem before delivery and during delivery (including delivery complications, fetal distress, amniotic fluid abnormal, abnormal placenta). After delivery she had high total bilirubin. No treatment was received by the patient for the event. The outcome of the injection site pain was recovered on an unknown date in 2021.   Follow-up attempts are completed. No further information is expected.  Follow-up (27Aug2021 and 14Sep2021): This is a follow up-spontaneous report from a contactable Pharmacist (patient). This Pharmacist (patient) reported in response to HCP letter via follow-up letter which included that: Age at vaccination, dose 1 details (date of vaccination, lot/batch no, dosing details), new events (injection site pain and maternal exposure during pregnancy, second trimester), medical history, pregnancy details and other clinically relevant information added and updated in narrative accordingly.
lit ref- pt taking OTC pseudoephedrine for wt loss died suddenly during exercise shortly p/vax;pt collapsed in mild weather while exercising 75min p/vax; presented in asystole w/ core temp 42.2C(108F), no urticaria or angioedema;
Parent called on 10/4/2023 Reporting deep lump to left thigh.  States she believes it emerged soon after the vaccines were given, but has not gone away.  about the size of a half dollar per mom. Recommended warm compress and massaging site, follow up in office if still present >2 weeks.
Developed hives, headache, and neck pain on the evening of 8/13/15 which lasted approximately a week.  Did not seek medical care at this time.  On approximately 9/7/15, developed headache, fatigue, dizziness, weakness, joint pains (without redness or swelling), and loss of typical skills (unable to complete dance moves as she could previously), intermittent palpitations.  Seen in office on 9/21/15.  Symptoms are continuing.  Normal cardiology consult.  Neurologist recommends MRI which is pending.