chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extensive leg swelling around the knee on the left leg above where the Prevnar and another shot (DTaP?) were administered.  The knee area was hot to the touch, red, swollen, and extremely painful a few hours following the injections.  We brought him back to the doctor at 10pm on the same day of the shots.  He said to watch it and see what it looks like in the morning.  The knee was less swollen in the morning but the screaming persisted.  He also had (painful) orange diarrhea for the first time that day and it has continued since then, with gradually less pain (crying) associated with it.  Also, after the shots, he could not sleep at night - he just cried.  He was never like that before - we used to have to wake him up to nurse.  After the shots, it took 3 weeks for him to begin to smile and laugh as he did previous to the shots.  He also would not look his mother in the eyes for a week following the shots.  He is gradually getting better, with the exception of the watery diarrhea.  We do not intend to have any more vaccines administered to him.  Our other child has never had this type of reaction to her shots.
A report was received from a health professional on 0/22/02, concerning a 6 month old male vaccinee who inadvertently received the Fluvirin vaccine on 10/11/02. The vaccinee experienced no adverse event. There was insufficient information to determine the reporter's causality assessment. Cross referenced with PJP200200621 and PJP200200622.
Caller stated her siblings experienced the same inflammatory response/inflammatory reaction specifically stating burning, back pain and difficulty walking; Caller stated her siblings experienced the same inflammatory response/inflammatory reaction specifically stating burning, back pain and difficulty walking; Caller stated her siblings experienced the same inflammatory response/inflammatory reaction specifically stating burning, back pain and difficulty walking; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 73 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Mar2021 (Lot number: EP7534) at the age of 73 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "multiple health challenges" (unspecified if ongoing), notes: My sister has multiple health challenges, prior. Family history included: "diabetic (Both Type 1)" (unspecified if ongoing), notes: Brother and sister who had the same response are both diabetic (Both Type 1). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Anatomical location: Left arm, Batch/Lot Number: EN6203), administration date: 04Mar2021, when the patient was 72 years old, for COVID-19 Immunization.  The following information was reported: BURNING SENSATION (non-serious), BACK PAIN (non-serious), GAIT DISTURBANCE (non-serious) all with onset 2021, outcome "unknown" and all described as "Caller stated her siblings experienced the same inflammatory response/inflammatory reaction specifically stating burning, back pain and difficulty walking".  Additional information: Patient had an inflammatory reaction specifically stating burning, back pain and difficulty walking. Patient stated the side effects are continuing 6 months later. Patient said the side effects were a functional issue affecting quality of life. Patient stated the second dose nearly incapacitated her. Patient asked if her side effects were neurological. Patient asked if they are neurological, is it going to go away. How can her HCP determine if it is long term or short term.  Patient stated her siblings experienced the same inflammatory response. Patient stated other people she has talked to experienced problems. Patient took vaccine in Public Health Clinic. No Prior vaccinations within 4 weeks. Brother and sister, who had the same response are both diabetic (Both Type 1). I am not Diabetic. Brother and I were in good health prior to the vaccine. My sister has multiple health challenges, prior.  No follow-up attempts are possible. No further information is expected.
I am early pregnancy- I haven't even had an ultrasound yet to calculate an exact due date. I am approximately 6 weeks.  About 12 hours after receiving the vaccine I became ill with body aches, chills, nausea, vomiting, general malaise and headache. I was sick until approximately 1530 on 1/10.
Case number PHEH2013US018511 is an initial spontaneous report received from a medical assistant on 30 AUG 2013. This report refers to a female patient whose age was not reported. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: M12124) intramuscularly on unspecified date. She experienced intense swelling of 2 inch radius, warmth and itching on 23 AUG 2013. The outcome of the event was reported as condition unchanged. The seriousness and causality was not reported.
This case was reported by a healthcare professional, via a GSK representative, and described the occurrence of erythema in a subject of unspecified age and gender who was vaccinated with combined KINRIX, GlaxoSmithKline. On an unspecified date the subject received unspecified dose of KINRIX (.5 ml, route unknown). At an unspecified time after vaccination with KINRIX, the subject experienced erythema, hardness injection site, swelling injection site and injection site warmth. At the time of reporting the outcome of the events was unspecified. The healthcare professional considered the events were probably related to vaccination with KINRIX. This case corresponds to a pharmaceutical product complaint. The healthcare professional reported that 15 subjects experienced the same events in the same time period after vaccination with KINRIX. At the time of reporting, no additional information was available. This is case 12 of 15 (see case IDs A0860669A, A0860688A, A0860690A - A0860698A, A0860700A - A0860702A for the other reports.
one of our Ambulance staff inadvertently used the same syringe to vaccinate eight people ? he did change the needles in between each patient.
Patient was diagnosed and treated for COVID-19 pneumonia at another facility from 6/27/2021 to 7/7/2021. She presented to the outside facility again on 7/8/2021 due to worsening shortness of breath, cough, chest pain, and oral thrush. Patient presented to emergency department again on 7/12/2021 at Covenant Healthcare for worsening hypoxia, shortness of breath, and cough. She was admitted for further management and is currently admitted at time of writing.
PT RECEIVED PNEUMONIA, AND FLU SHOT ON THURSDAY, ON FRIDAY THE PT HAD A RED TENDER AREA AT INJECTION SITE.. ON SUNDAY PT REPORTS THE RED AREA HAD SPREAD AND HAD TENDERNESS HAD INCREASED.  PT CAME TO ER FOR TREATMENT. MD NOTED MOTTED REDDNESS TO INJECTION SITE. (SITE LT UPPER LEG)
Patient was diagnosed on 4/22/21 SARS-COV-19 after completing the series of vaccinations.
-Arm swelling, red hot to touch, bruising, itching, sweats cold feeling fevers.  - Tennis ball size swelling -Swollen vein
?COVID Arm? - red itchy rash around injection point along with tightness. Roughly 2-3 inches wide.
Patient woke up two black eyes going from corner of her eye to her temple; This spontaneous case was received on 03-Oct-2023 from other healthcare professional via Company (reference number SEQW23-02899) with additional document received on the same date from Company (reference number: SEQW23-02899) (being processed together) and concerned an 80-year-old, female patient.  The patient's medical history was not reported. The patient's concomitant medications included Zetia (ezetimibe), losartan, alprazolam, hydrochlorothiazide (reported as hydroclorothyosine), rosuvastatin and warfarin, all used for unreported indication.  On 02-Oct-2023, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5ml, route of administration and anatomical location: not reported) as influenza immunization. The batch number reported was 370679 and expiration date 10-May-2024.  On 03-Oct-2023, one day after receiving Fluad Quadrivalent, the patient experienced two black eyes going from corner of her eye to her temple.  At the time of the initial reporting, the patient had not recovered from the event.  The reporter did not provide a causality assessment.   The case was assessed as non-serious.  Company comment: A 80-year-old female patient experienced eye contusion on both eyes one day after being vaccinated with Fluad Quadrivalent. Causality is confounded by therapy with concomitant medication warfarin. Patient's medical history and relevant diagnostic findings were not provided. Due to temporal plausibility, causal role of the suspect vaccine is assessed as possibly related for the reported event.; Sender's Comments: A 80-year-old female patient experienced eye contusion on both eyes one day after being vaccinated with Fluad Quadrivalent. Causality is confounded by therapy with concomitant medication warfarin. Patient's medical history and relevant diagnostic findings were not provided. Due to temporal plausibility, causal role of the suspect vaccine is assessed as possibly related for the reported event.
Patient received his HD flu shot 10/7/2015. at 5:40pm patient and wife showed up at clinic c/u inability to move bilateral legs at home, increased sweating, chest pain, and dyspnea. 911 called and patient transferred to ER.
60mm by 60mm reddened flattened area at injection site with hard "nodule" in center. Warm to touch and painful. Runny nose, fever of 102, sore throat, and bloody mucus symptoms started early in AM of 10/02/14. Patient seeking treatment at her PCP tomorrow 10/3/14.
I had extreme diarrhea a week after my vaccination and I have never experienced this before. I lost a total of 10 pounds because of it and it all happened after I got my Pfizer COVID-19 Vaccine. I had to see a doctor (Gastroenterologist) and was diagnosed with Microscopic Colitis and was prescribed with steroids (desonide), (3 tablets/day) on the 1st month and 2 tablets for the 2nd month and 1 tablet for the 3rd month. After the 1st day of taking desonide my diarrhea went away.
This spontaneous report was received from a certified medial assistant regarding a patient of unknown age and gender. information on the concurrent conditions and medical history of the patient was not reported. On 29-MAR-2016, the patients was vaccinated with unspecified doses of improperly stored GARDASIL immunization series lot # K011562, expiry date 08-APR-2017, dose #, units, frequency, route and anatomical location were not specified. Concomitant medication were not reported. There were no adverse effects reported. There was no Product Quality Complaint (PQC) involved. Temperature and time frame at which the product the product was exposed was 33 degree Fahrenheit for 72 hours. Temperature and time frame at which the product was exposed previously: 34 degree Fahrenheit for 72 hours and 47 degree Fahrenheit for 12 hours. This is one of several reports received from the same reporter. Additional information has been requested.
Event not reported until s/s disappeared. 3 min post 1st Tet shot donor had tingling fingers increase arms and body, chills, sweating, nausea, dizziness - duration approx 7 min. Also for about 2 min his breathing felt heavy. Donor went in rest room and stayed until s/s went away.
Lightheadedness and dizziness immediately after injection. Flushing, anxiety, rash around neck and shoulders, itching approximately 1 hour after injection.
Patient called on 05/3/2021 am and informed that she experienced muscle cramps the night of the vaccine. Was better in the am. Advised Patient to call physician if symptoms get worse. Called to see how patient was faring there was no answer. Left voice message to call the pharmacy back.
09/13/23 2300 arrived to emergency department  09/14/2023 0815 code started, chest compressions, epinephrine x 10 throughout code, plasmalyte, calcium chloride, plasma and packed RBC administered 09/14/2023 0930 code ended
Information has been received from 2 healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 02-FEB-2015, the patient was received improperly stored VARIVAX (Merck) (lot # K007979, exp date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Facial swelling/ Swelling was around the lips and jaw; rapid heart rate; a little bit of facial numbness; Swelling was around the lips and jaw; There was edema around the mouth and cheeks and under her right chin; There was a fold coming down from her mouth that didn't used to be there; This is a spontaneous report from a contactable consumer, the patient.     A 45-years-old female patient received first dose of bnt162b2 (PFIZER BIONTECH COVID 19 VACCINE, formulation: solution for injection, lot number was not reported) an unspecified route of administration, in arm left on 12Apr2021 at 10:15 as dose 1, single (age at vaccination 45 years) for covid-19 immunisation. Medical history included low thyroid, ongoing. The patient's concomitant medications included natural thyroid for low thyroid that she had been taking for years but does not have name and dose information for this product at the moment. On 16Apr2021 the patient was having facial swelling since 3 days after the vaccine. She got the vaccine on Monday and noticed this by Friday morning, so the fourth day. The swelling was around the lips and jaw on an unknown date in 2021. There was a fold coming down from her mouth that didn't used to be there on an unknown date in 2021. First noticed when she took off her mask. There was edema around the mouth and cheeks and under her right chin on an unknown date in 2021. The patient received treatment for the facial swelling, she had tried antihistamines and Advil, was thinking it might be getting a little better but waking up this morning, it was the same and had been persistent. She even tried acupuncture. Tried things for drainage, lymphatic drainage. The patient did not get any relevant tests done. The patient was told that this will go away, that it was just edema or something but it did not. There was no history of previous immunizations. No additional vaccines were administered on same date. The patient did not visit emergency room or physician's office. There were no prior vaccinations within 4 weeks. She has lots of autoimmunity in the family and sensitive to additives, preservatives and medications. The outcome of the events Facial swelling/ Swelling was around the lips and jaw was not recovered, of rapid heart rate and a little bit of facial numbness was recovered on 12Apr2021, and for the rest was unknown.  Description of Product Complaint: The patient mentioned regarding treatment for the facial swelling that she has tried antihistamines and Advil, was thinking it might be getting a little better but waking up this morning, it is the same and has been persistent.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pain on injection site; This is a spontaneous report from contactable consumer (patient) through a Pfizer sales representative.  A patient of an unspecified age and gender received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine,) at single dose, on an unspecified date, for COVID-19 immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, 8 hours after the vaccination, the patient experienced pain on injection site. Clinical outcome of the adverse event was unknown at time of this report.  No follow-up attempts are possible, information about lot number cannot be obtained.
Resident began having fever on 1/11/21 @0600. VS= T-102 B/P- 100/57 P- 112 RR- 24 O2 Sat 92% on RA. MD called. Rapid COVID Test was negative. CBC,CMP, U/A were ordered as well as CXR. Resident's condition declined. At 3:00pm resident started having respiratory distress and hypoxia O2 Sat 89%. Supplemental O2/mask @ 5LPM. Neb TX, EKG, and Rocephin 1 GM ordered. Condition worsened. Resident sent to nearest ER for evaluation. Later in the evening the staff AT Medical Center called to inform staff that resident had expired @ 2230 as a result of Respiratory Failure and Sepsis.
Patient sat for 5 minutes after vaccines, felt fine. Rose to stand slowly and was fine. Discharged from office. 5 minutes later felt dizzy while at the appointment desk. Color pale, clammy skin. Recovered with supine position and Oxygen, OJ to drink. Had no lunch today. Discharged from office at 3:30 pm.
full body rash, fever 101.5 not relieved by tylenol, lethargy, decreased appetite. resolved within 2 days. pt better as of 9/15/2022
Frozen Shoulder (adhesive capsulitis): shoulder pain and stiffness. Then, significant loss of range of motion.
Developed red, maculopapular rash over much of body within 2 hours of vax. Referred to ER, no action was taken.
11 minutes after vaccine this employee developed a metallic taste in her mouth, tachycardia and hives on her chest and neck. She reports her heart rate normalized quickly. Before she went to bed, she felt her tongue slightly swell and developed a scratchy throat. She reports the top portion of her throat feeling swollen as well. Benadryl resolved the symptoms.
at about 17 hours after injection: high fever 101.6, chills, nausea, muscle aches, very severe headache, lethargic, light sensitivity, sore arm
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030H218) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Pfizer / BioNTech (Dose Number: 1 Batch/Lot No: EN6205 Location of injection: Arm Right) on 02-Mar-2021 and Pfizer / BioNTech (Dose Number: 2 Batch/Lot No: ED6955 Location of injection: Arm Right) on 23-Mar-2021. Past adverse reactions to the above products included No adverse event with Pfizer / BioNTech and Pfizer / BioNTech.    On 03-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 05-May-2022 to 10-May-2022 for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-May-2022, SARS-CoV-2 test: positive (Positive) Positive home COVID test. On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.         Concomitant medication of the patient was not reported. It was also reported that, the patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment.  On 15-May-2022, on the 5th day after final dose of Paxlovid, the patient had rebound of symptoms.  Company Comment: This is a spontaneous case concerning  a  patient of unknown age and gender with no relevant medical history, who experienced the unexpected non-serious event of Covid-19. The event occurred on an unknown day after the third dose of mRNA-1273 COVID 19 Vaccine. Patient tested positive for SARS-CoV-2 test. Patient was treated with nirmatrelvir, ritonavir of unknown dose and frequency. The events was reported as resolving. It was noted that 5th day of the final dose of nirmatrelvir, ritonavir which was on May 15, 2022, patient had rebound of symptoms and tested positive for SARS COV -2 Test. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.; Sender's Comments: Company Comment: This is a spontaneous case concerning  a  patient of unknown age and gender with no relevant medical history, who experienced the unexpected non-serious event of Covid-19. The event occurred on an unknown day after the third dose of mRNA-1273 COVID 19 Vaccine. Patient tested positive for SARS-CoV-2 test. Patient was treated with nirmatrelvir, ritonavir of unknown dose and frequency. The events was reported as resolving. It was noted that 5th day of the final dose of nirmatrelvir, ritonavir which was on May 15, 2022, patient had rebound of symptoms and tested positive for SARS COV -2 Test. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.
Information has been received from a health professional concerning now a five year old female who on 10/22/1996 was vaccinated with one dose of varicella vaccine. Subsequently, it was reported that on 05/14/2001 the pt was diagnosed with a "mild case of chicken pox." Unspecified medical attention was sought. It was reported that in the spring of 2001, there was a very large chicken pox outbreak in the area. It was not specified whether or not the pt had an exposure to these cases. Subsequently, the pt recovered. No further info is available.
Flu shot - pt's arm hurt the night of the shot ("very sore"). She took Ibuprofen - dose not reported. Now 3 wks later she still has joint pain in the shoulder of the arm shot was given - no muscle soreness. Pt wanted reported due to joint pain.
pt devel cellulitis p/vax which was mixed in the same syringe & injected into one site;this is 1 of 2 pt from this site to devel cellulitis p/vax;MEDICAL AFFAIRS NOTE: it is recommended that flu vax & pnu-immune be inj into different sites;
ITCHING; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 2021, the subject experienced itching. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of itching was not reported. This report was non-serious.
Hives on face, head, neck, chest immediately after vaccine. Took Benadryl with no relief. Prescribed prednisone and steroid cream . Helped but hives returned after prednisone ran out.  Prescribed extra dose of zrytec- no relief after 2 weeks. Consistent use of steroid and albuterol inhalers starting day after- use 3-5 time daily, still after 2 weeks. Menstrual like cramping starting 1 week after- continues after week 2. I had a hysterectomy 10 years ago and haven?t had cramping since then. Sore, very sensitive nipples starting 1 week after.  Migraine like headache and fever of 102 after week 1 lasting 2 days.
headache, nausea, chills, aching but those went away by saturday ;however my arm has hurt from the second day and is red, quite warm to touch, swollen and painful (has kept me from hours of sleep)