chrisvoncsefalvay/vaers-outcomes huggingface dataset:
urge to have a BM; left side of head had a funny sensation; Chills; hot flashes in my upper body; feels strange and voice has changed; feels strange and voice has changed; suddenly had to have a bowel movement; This is a spontaneous report from a contactable consumer or other non-HCP. A 76-years-old female patient (at the age of: 76-years) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6203; Expiration Date: 30Jun2021), via an unspecified route of administration, administered in Left Arm on an unspecified date as 1st dose, single for covid-19 immunization. The patient Medical history was not reported. Concomitant medication included losartan potassium 50 mg once a day, ergocalciferol (VIT D) and calcium taken for an unspecified indication, start and stop date were not reported. No vaccination within four weeks prior to the first administration date of the suspect vaccine and No Family medical history relevant to ae and relevant tests. The patient experienced chills, hot flashes in my upper body, feels strange and voice has changed, and suddenly had to have a bowel movement on 02Mar2021, urge to have a bm and left side of head had a funny sensation on an unspecified date.  she got the first dose of the Pfizer Covid vaccine this morning around 08:00 AM, then the person who gave her the shot asked her what medication she takes and she told them, they did not say anything to her about it. States she took her medication for blood pressure around 09:30 AM at her regular time to take the medication, wants to know if it is okay Takes Losartan Potassium 50mg one time a day, states she took it with Vitamin D and Calcium. And States her voice is changed, she feels strange, states around 10:20 wanted to take bowel movement suddenly, could be a regular thing, states she feels some sort of hot flash sensations not bad, here and there and then feel chills. The patient underwent lab tests and procedures which included weight fluctuates between 144 and 145 on unspecified date. The outcome of the events feels strange, and voice has changed was not resolved and other events was unknown.   No follow-up attempts are possible. No further information is expected.
Covid test result=Positive; covid_test_result=Positive; spread body rash all over my arms. Chest, torso, thighs and calves that got worse over time.; developed a wide spread body rash/that got worse over time; This is a spontaneous report from a contactable consumer (patient herself). A 41-years-old (non-pregnant) female patient received bnt162b2 (COMIRNATY, solution for injection, Batch/Lot Number: FC3183) via intramuscular route of administration in right arm on 02Sep2021 as DOSE 2, SINGLE (age at vaccination 41 years) for covid-19 immunisation and dose 1 of bnt162b2 (COMIRNATY, solution for injection, Batch/Lot Number: FC3181) via intramuscular route of administration in right arm on 12Aug2021 as DOSE 1, SINGLE (age at vaccination 41 years) for covid-19 immunisation. The patient had no known allergies. The patient concomitant medications were not reported. The patient's other medical history was reported as none. Patient received most recent COVID-19 vaccine at Pharmacy or Drug Store. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient had not received any other medications within 2 weeks of vaccination. The patient had not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. After 6 days of vaccination on 11Sep2021 patient experienced wide spread body rash all over her arms, chest, torso, thighs and calves that got worse over time. It lasted about 4 weeks. Rash has gotten better but still a little on her thighs. The patient underwent nasal swab test on 18Oct2021 with result positive. Adverse event resulted patient visited Doctor or other healthcare professional office/clinic visit. Patient received treatment for events with multiple medrol dose packs, 5 day course anti viral medication, z pack and topical steroid cream. The outcome of events were recovering.
Pt experienced vasovagal reaction within one minute following injection of HPV # 3.  She was sitting on the exam table during vaccine administration. Nurse completed administration, applied bandage, & turned to put syringe in sharps container. Pt fell off table and hit back/side of head on the floor. Pt was observed for approximately 30 minutes and examined by physician before being allowed to leave office. We feel that this was a vasovagal reaction not related to the vaccine itself.  Pt has had two other Gardisil vaccines without any problems.
Pt had red welts, warm to touch in deltoid area. Treated with Keflex, 500mg and Vistaril 25mg.
This spontaneous report was received from a vaccine coordinator refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions and allergies were not reported. Concomitant therapies were not provided. On 15-MAR-2018, the patient was vaccinated with an expired VAQTA lot # M022924 with an expiration date 24-JAN-2018 for prophylaxis (dose, route of administration and anatomical location were not reported). No adverse effects were reported.
fine rash (bumpy) on face spreading; recvd MMR 10 days ago;
first dose of Shingrix over 2 years ago; This case was reported by a consumer and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose over 2 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided are as follows: The case was reported by patient for himself/herself. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter asked that he/she could get the 2nd dose now or did have to repeat the 1st dose. The follow-up could not be possible as no contact details were available.
J96.00 ACUTE RESPIRATORY FAILURE- 6/10/2021 MITRAL VALVE REGURGITATION; J96.00 ACUTE RESPIRATORY FAILURE- 6/10/2021 MITRAL VALVE REGURGITATION; J96.00 ACUTE RESPIRATORY FAILURE-6/10/2021 COPD STAGE 2 MODERATE (FEV1 50-79%).
suffered a painful rash on the penis, testicles and anus. patient was diagnosed with herpes zoster; Information has been received from a lawyer regarding a case in litigation concerning a patient (pt) (age and gender unknown). The pt's medical history, concurrent conditions and concomitant medication were not provided. On or around 17-APR-2012, the pt was vaccinated with zoster vaccine live (ZOSTAVAX), (lot# and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) (date not reported), the pt suffered a painful rash on the penis, testicles and anus. The pt was diagnosed with herpes zoster. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event herpes zoster on the penis, testicles and anus was considered to be not recovered and causal relationship was assessed as related.  The reporter considered the event herpes zoster on the penis, testicles and anus to be disability.
Information has been received from a physician concerning a 5 month old female with a history of premature birth who was vaccinated PO with her first dose of Rotateq (lot# 655483/1116F).  Subsequently the patient experienced diarrhea "4 days after the dose."  Unspecified medical attention was sought.  Subsequently, the patient recovered.  There was no product quality complaint.  Additional information has been requested. Additional information from the reporting physician indicated that the 25 week old female with retinopathy of prematurity and "GEX" and a history of premature birth who on 22-MAY-2007 at 14:30 was vaccinated PO with her first dose ROTATEQ (lot # 655483/1116F). On 26-MAY-2007 the patient experienced acute diarrhea 4 days after administration. A laboratory test also confirmed that the patient tested positive for rotavirus. It was noted that the patinet was progressively getting worse (previously reported as recovered from diarrhea). Additional information has been requested.
Anaphylaxis. Face, lips, throat swelling. Epi in each leg. Benadryl in right arm.
Strong weakness, nausea, headache, chills, elevated heartbeat, and 37.5 C fever. Unable to perform my daily functions.
Patient received a second bivalent dose and it was a Moderna Bivalent; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (Patient received a second bivalent dose and it was a Moderna Bivalent) and NO ADVERSE EVENT (No adverse event) in an 89-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 051D22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer on 15-Oct-2022. Past adverse reactions to the above products included No adverse event with Pfizer.    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)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (Patient received a second bivalent dose and it was a Moderna Bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (Patient received a second bivalent dose and it was a Moderna 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXTRA DOSE ADMINISTERED (Patient received a second bivalent dose and it was a Moderna Bivalent).    No concomitant information was reported. No treatment information was provided.
Has patient ever had Covid positive test or diagnosis; Has patient ever had Covid positive test or diagnosis; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MOD22-023857 (Moderna).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and in Jul2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "diabetes (controlled with diet)" (unspecified if ongoing), notes: diabetes (controlled with diet); "Allergies: Sulfa" (unspecified if ongoing), notes: Allergies: Sulfa. The patient's concomitant medications were not reported. Past drug history included: Tetracycline, reaction(s): "Allergies: Tetracycline", notes: Allergies: Tetracycline. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Has patient ever had Covid positive test or diagnosis". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2021) Positive, notes: Has patient ever had COVID positive test or diagnosis? Jun2021 and Oct2021; (Oct2021) Positive, notes: Has patient ever had COVID positive test or diagnosis? Jun2021 and Oct2021.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Friday,15th January 2021, at 10.24, i had the first of the Montary inoculation. The next day, Saturday, i atended a oat show where is was jumpin ong and off different boats with no difficulity. the following Teusday, i went to ER due to a tingling feeling in my left are, along with very bad muscle spasms in my left are. I was told that this was normal with an inoculation of this kind and not to worry. throughout the  balance the week the pain got steadly worse until friday, icould hardly walk.  saturdy morning . I fell at home, my legs would not support my body. I went to the ER and was admitted. over the next several days, iwas examined, had mulitple blood work, eventually the Dr's came to the conclusion
Around 2 weeks after my first dose, I started having heart palpitations. The palpitations were on and off for a week and I didn't think of it much. A week after the palpitations started it started happening more frequently and I was feeling light headed and I went to ER. I was diagnosed with SVT and put on metoprolol to control my heart rate. 1 week after I was on metoprolol, I took my second dose. I was feeling a little dizzy after my second dose but it improved after like 10 minutes. I started getting very fatigued and difficult to concentrate after my second dose. I  spoke to my doctor and we thought it was because of metoprolol. My cardiologist took me off metoprolol but the fatigue didn't stop and I started having aches in shoulders, arms, neck and back. The aches and fatigue was more severe in the morning. After a week of being off metoprolol I started waking up with chest pain. One day the pain was severe and I had aches in shoulders, arms, neck and back and my heart rate was around 140 so I went to ER. The doctors put me on carvedilol and my heart rate has been controlled but my body aches and fatigue has been going on. The cardiologist and my PCP aren't sure if SVT or the medication is causing my body aches and fatigue. The only other thing I could think of was the vaccine so I wanted to send this report.
The 3rd day after shot, the pain in my arm worsened and I can't lift my arm without severe pain.  It hurts even when I'm not moving it.
Shingles after jab/Suspected vaccination failure; Shingles from the vax; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 27-Mar-2023 Reporter's comment: The case was received from the patient's cousin via interactive digital media. The reporter reported that the it was one of the side effects from taking the shot. The patient got shingles from the vax. The reporter reported that they both (reporter's brother and cousin) took the same one and it was sad, so many were duped including you. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. The case was linked with case US2023AMR036508, reported by same reporter for different patient.; Sender's Comments:  US-GSK-US2023AMR036508:Same reporter
She started with a sore throat on 10/6 late at night. She started with nausea 10/7. She was vomiting 10/8.
After the shot, my arm was very sore. It has progressively gotten worse over the last 7 months. I went to the orthopedic doctor and the office sent me to get Xrays and to PT. They are unsure what is wrong but have diagnosed me with should impingement syndrome. I have to do physical therapy for 6 weeks and hope that it improves.
2 days after 2nd dose of Moderna COVID vaccine had 2 hours of tachycardia with rates of 150-160, since then I have had irregular heart rate daily,  fatigue, some  shortness of breath, no specific chest pain, some days more than others and no correlation with activity, during night and day. This has been ongoing for 4 weeks, I have pending appt with Cardiologist, Nov. 3, 2021 to evaluate.
My feet had a situation called Morton's Neuroma, and was worsening after the booster. Contacted on 01/2022 for consult for surgery because the prior treatment of cortisone shot wasn't working. It, so far was an option that I am considering. This all started back in April of 2021 where my started hurting after knee injury in March. It was first thought it was because I was on crutches. Blood work was done during the summer and it discovered nothing, all normal Also, x-ray and ultrasound was done and that is when ultrasound tests discovered the plantar fasciitis and later found the Morton's Neuroma. So based on physicals and advice from doctor it was determined that I needed surgery. I have yet to determine if I want the surgery.
This spontaneous report was received from a medical assistant and refers to a 4 year old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 12-JUL-2018, at wellness visit, the patient was inadvertently vaccinated with 2 doses of (wistar ra 27-3) M-M-R II injection, lot # N025891, expiration date 19-SEP-2019 (exact dose, route of administration and anatomical localization were not reported), which were reconstituted with sterile diluent, lot # M040413, expiration date 25-MAY-2019. No adverse effects were reported. Lot number N025891 has been verified to be a valid lot number for (wistar ra 27-3) M-M-R II.
joint pains; metallic flavor in mouth; his joints, knees, and elbows were hurting; headache; discomfort; injection site soreness; slight flushness; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 47-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EL1283, Expiration Date: 30Apr2021) via an unspecified route of administration, administered in Arm Left on 13Jan2021 13:30 (at the age of 47-years-old) as dose 1, single for COVID-19 immunization. Medical history included shin splints (1991-1995 is when this started, that was more because of shoe cushioning wearing out ) and migraine (started 1992 or 1993 while in the military) from an unknown date and unknown if ongoing. Concomitant medication included unspecified vitamins and bifidobacterium bifidum, bifidobacterium lactis, lactobacillus acidophilus, lactobacillus brevis, lactobacillus bulgaricus, lactobacillus casei, lactobacillus paracasei, lactobacillus plantarum, lactobacillus rhamnosus, lactobacillus salivarius (PROBIOTIC 10) taken for an unspecified indication, has been taking for about 7 or 8 months. No investigation assessment was performed. No prior vaccinations within 4 weeks. On an unspecified date in Jan2021, the patient experienced injection site soreness, this happened and hour or two after receiving the vaccines. This didn't go away until the following day. Most of the other symptoms besides the injection site soreness happened when he woke up the following day after receiving the first vaccine. He had slight flushness, discomfort, his joints, knees, and elbows were hurting and headache. He mentioned that he had migraines and sinus infections before, but this was just a strong headache. The headache lasted about a day and a half. He had no fever but felt flushed- he felt warm. On 14Jan2021, the patient had joint pain and metallic flavor in mouth. He compared it to when a person was receiving a CAT scan or something and they give an injection, and the person gets a flavor in their mouth. He was drinking water and juice and the metallic flavor was still there.  He thought this was just normal since COVID makes people lose their sense of taste, so maybe the metallic flavor was a reaction. With the first vaccine, symptoms were pretty mild. He stated that  most events happened on the 14Jan2021, he was back to normal on 15Jan2021. No visit to ER or Physician. Therapeutic measures were taken as a result of joint pain. The outcome of the events was recovered on 15Jan2021.  No follow-up attempts are needed. No further information is expected.
a 11 year old had received a Menactra in 2016 and then another dose in 2017, no AE; Initial information received on 02-Mar-2021 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 12 years old female patient who received first dose of  MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] at 11 years old in 2016 and had received another dose in 2017 via unknown route in unknown administration site for prophylactic vaccination  (batch number and expiration date of first dose in 2016 were not reported; 2017's batch number :U5514AC expiration date12-Mar-2018) (extra dose administered). Also reported that now she was 16 year old, and should they give her the booster dose, since she got 2 doses earlier?   The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   It was an actual medication error due to extra dose administered.  No specific AE (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 holder's compliance with the requirements set out in the 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.
5/29 Had chills, dry throat, felt feverish-but had no thermometer to check temp. Noticed a mild, raised rash over neck and trunk. Not itchy, not very red, resolved within 24 hrs. 5/30 Feverish off and on, felt tired and weak, existing lymph node on right side under ear still hard. 6/30/04 has completed all vaccine series no further reaction.