chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient Mentioned that she got covid positive on 01Apr2022; fever; chills at night; little sore in the arm; Patient Mentioned that she got covid positive on 01Apr2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): MOD22-013255 (Moderna).  A 73-year-old female patient received BNT162b2 (BNT162B2), on 23Feb2021 as dose 1, single (Batch/Lot number: unknown), on 16Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 05Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 73 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 06May2022 as dose 4 (booster), single (Lot number: 057M21A) for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing), notes: Condition 1: patient mentioned that she has high blood pressure. The patient's concomitant medications were not reported. Past drug history included: Advil, reaction(s): "Allergy", notes: Patient mentioned that she has allergies with High doses of Advil 800mg. The following information was reported: COVID-19 (medically significant) with onset 01Apr2022, outcome "unknown", VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "Patient Mentioned that she got covid positive on 01Apr2022"; CHILLS (non-serious) with onset 06May2022, outcome "unknown", described as "chills at night"; PYREXIA (non-serious) with onset 06May2022, outcome "not recovered", described as "fever"; PAIN IN EXTREMITY (non-serious) with onset 06May2022, outcome "unknown", described as "little sore in the arm". The patient underwent the following laboratory tests and procedures: Body temperature: (unspecified date) 99.8 to 101.2, notes: According to the patient, she still has a low-grade fever about 99.8 to 101.2; SARS-CoV-2 test: (01Apr2022) Positive.  Clinical course:The Caller called in behalf of her wife who experienced side-effects after getting the second booster dose of Moderna. Both him and his wife got the second Moderna booster day before day 06May2022. He mentioned that his wife had a fever and chills last night which he read are general side-effects of the vaccine. Patient also mentioned that she still has low-grade fever about 99.8 to 101.2 and a little sore in the arm. The caller wants to know if his wife is contagious and if is it ok to have a covid test even if they got the vaccine. Patient also mentioned that the pharmacist told her that she could get the vaccine after 2 weeks of having positive with Covid on 01Apr2022. The caller gave consent to be contacted by safety  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
At time of injection pt. reported pain but did not note concerns. Noted continued pain in shoulder joint and limited range of motion over next 24 hours. About 48 hours post vaccine pain remained "10/10" and went to ER. ER Doc noted imm. likely placed in joint capsule. Pain meds given. Exam today WNL. Pain 3/10 Passive full ROM.
received coronavirus booster vaccine; sick; symptoms of arthritis flare in right arm; skin hot/ red around shoulder; skin hot/ red around shoulder; soreness; This is a spontaneous report from a contactable other hcp. A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported) via an unspecified route of administration on 25Aug2021 as dose 3, (BOOSTER) single for COVID-19 immunization (at the age of 56-year-old); tofacitinib citrate (XELJANZ XR), oral from 01Oct2020 (Batch/Lot number was not reported) and ongoing, at 11 mg, daily for rheumatoid arthritis. The patient's medical history and concomitant medications were not reported. The patient historical vaccine included dose 1 and dose 2 of BNT162B2 (Lot number and expiration date was not reported) via an unspecified route of administration on an unspecified dates for COVID-19 immunization. The patient received coronavirus booster vaccine on 25Aug2021 and experienced sick, symptoms of arthritis flare in right arm, skin hot/ red around shoulder, soreness on an unspecified date in 2021. It was reported that, after start of therapy "rarely" missed a dose of xeljanz, took later than normal schedule (morning) over the last few weeks. Unknown if change in symptoms and received coronavirus booster vaccine on 25Aug2021 and was sick for 1 day/no fever, symptoms of arthritis flare in right arm/skin hot/red around shoulder, soreness for several days, better today. MD was unaware and encouraged to notify MD. No additional information/details provided. The outcome of the event sick and soreness was recovered on an unspecified date in 2021, and for symptoms of arthritis flare in right arm, skin hot/ red around shoulder, received coronavirus booster vaccine it was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
pt came in for routine 5yr physical was nl-recv DTAP/OPV/MMR came back w/severe belly pain, swollen hands & feet, no fever, w/rash on head & neck given DPH;pt sent home w/sx fading;
Discharge Provider: MD  Primary Care Provider: MD Admission Date: 3/8/2023 Discharge Date: Mar 26, 2023 PRESENTING PROBLEM: Severe sepsis (HCC)  Septic shock (HCC)  Sepsis (HCC) SBO (small bowel obstruction) (HCC)   HOSPITAL COURSE: 72 year old male with past medical history quadriplegic, bilateral AKA, neurogenic bladder, seizure, PVD, HTN presented from a nursing facility with lethargy, hypoxia and shock. He was found to be Covid-19 positive. He as placed on bipap then HFNC and improved on NC.  He then developed septic shock due to urinary tract infection, possible superimposed bacterial and aspiration pneumonia.  He was treated with multiple IV antibiotics including meropenem, vancomycin, cefepime and Zosyn with improvement.  While hospitalized he developed a small-bowel obstruction.  General surgery evaluated the patient and he underwent exploratory laparotomy with lysis of adhesion and small-bowel resection on 03/16.  Repeat imaging showed an ileus.  The patient had an NG tube but ultimately this was removed and the patient diet was slowly advanced.  He required TPN while NPO due to small-bowel obstruction.  He received Decadron for COVID with slow improvement in his respiratory status.  He was weaned to nasal cannula.  Also while hospitalized he developed atrial fibrillation and flutter.  He was treated with amiodarone and converted to normal sinus rhythm.  He was started on IV heparin drip with plan to transition to another facility on DC.  Ultimately the patient was discharged in stable and improved condition on 03/26/2023
Patient developed mental status changes within 5 minutes of vaccine administration. Unable to verbally respond to questions and unusual jaw movements progressing to complete unresponsiveness, drooling and eventual convulsions. Epi-pen was administered 15 mins after symptoms developed to right thigh.  From time of immunization to EMS transport to hospital approx 20 mins.
Information has been received from a nurse, via a company representative, concerning an unknown number of female patient's, who were vaccinated IM, with a dose of GARDASIL vaccine (yeast) (Lot # not provided). The nurse stated that "on a couple of occasions" a lump formed almost immediately at the injection site. The nurse confirmed that the lumps dissipated within 1 to 2 weeks. The patient sought unspecified medical attention. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additinal information will be provided if available. Additional information has been requested. This in follw-up  to report(s) previously submitted on 8/14/2007. Initial and follw information has been recieved from a nurse concerning approximately ten female patients, aged 17 to 19 years., who were vaccinated IM witha 1 to 1.5 gauge needle witha adose of GARDASIL vaccine (yeast) (lot # 657736/0389U). The nurse stated that a lump formed almost immediately
Itching at injection site; Swelling the size of baseball near injection site; Chills; Red at injection site; Strange Taste in mouth; This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (Strange Taste in mouth), VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE ERYTHEMA (Red at injection site), VACCINATION SITE SWELLING (Swelling the size of baseball near injection site) and CHILLS (Chills) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced TASTE DISORDER (Strange Taste in mouth), VACCINATION SITE ERYTHEMA (Red at injection site) and CHILLS (Chills). On 24-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itching at injection site) and VACCINATION SITE SWELLING (Swelling the size of baseball near injection site). On 20-Feb-2021, CHILLS (Chills) had resolved. On 21-Feb-2021, TASTE DISORDER (Strange Taste in mouth) and VACCINATION SITE ERYTHEMA (Red at injection site) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Itching at injection site) and VACCINATION SITE SWELLING (Swelling the size of baseball near injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.
PUNCTURED VIAL STORED IN REFRIGERATION BEYOND THE RECOMMENDED 6 HOURS; ADMINISTRATION OF A DOSE OF THE VACCINE THAT WAS STORED OUTSIDE OF THE RECOMMENDED STORAGE CONDITIONS; This spontaneous report received from a pharmacist concerned a 38 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: No known allergies. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: 21-SEP-2021) dose was not reported, administered on 24-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-AUG-2021, the patient experienced administration of a dose of the vaccine that was stored outside of the recommended storage conditions. On an unspecified date, the patient experienced punctured vial stored in refrigeration beyond the recommended 6 hours. The action taken with covid-19 vaccine was not applicable. The outcome of the administration of a dose of the vaccine that was stored outside of the recommended storage conditions and punctured vial stored in refrigeration beyond the recommended 6 hours was not reported. This report was non-serious. This case, from the same reporter is linked to 20210855201 and 20210855614.
After receiving immunizations, had started with severe desaturization and apnea requiring ambulation and NPO status. Continued with episodes for 24 hours and 48 hours after less severe but continued with desat. Required increased O2 and stimulation.
10/8/2011 PM. Patient complains of pain in arm and neck originating at injection site. A headache was also reported. The area of injection looked red and inflamed. Patient went to ER. Test results were negative. Patient's symptoms have improved since then with pain medication.
Received vaccine on Tuesday -> symptoms started on Friday but got more severe on Saturday & Sunday. Symptoms included constant sneezing, severe headache, fatigue, running nose migraine medicine on Sunday was helpful to headache.
PUI is currently hospitalized for COVID symptoms. Updated patient representative information with son's phone number and name. PUI symptoms include: fever, chills, cough, difficulty breathing, fatigue, headache and abdominal pain. Symptoms have not resolved and PUI was transported by ambulance to the hospital 8/31/21. PUI has been taking Tylenol with possibly the last dose taken on 8/30/21. PUI has diabetes, asthma, and is currently on kidney dialysis.  Patient is fully vaccinated.
Within 15 minutes, I began feeling dry throat; Within 15 minutes, I began feeling dry throat, then itching, then it felt like I had a lump inside my throat.; it felt like I had a lump inside my throat.; Then I began to have difficulty swallowing my saliva.; difficulty breathing; very groggy; This is a spontaneous report from a contactable pharmacist. A 47-year-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0140), intramuscular in left arm on 20Dec2020 at a single dose for COVID-19 immunization. Vaccination was administered in a hospital. Prior to vaccination, the patient was not diagnosed with COVID-19. Medical history included hypertension, overweight, and known allergies to bee stings and hair dye. The patient's concomitant medication included multivitamins. On 20Dec2020, within 15 minutes, the patient began feeling dry throat, then itching, then it felt like she had a lump inside her throat. Then she began to have difficulty swallowing her saliva. And then the lump inside her throat started to feel larger and larger. By this time, the doctor had already injected the patient with Epipen and the pharmacist injected her with Solumedrol and she still felt as if she was having difficulty breathing and then she was taken to ER and she really can't remember too much after that. The patient was very groggy and then was discharged from ED about 9:30 pm. The outcome of the events was recovered on an unknown date. Treatment for the events included epinephrine, methylprednisolone, diphenhydramine. Since the vaccination, the patient has not been tested for COVID-19.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of feeling dry throat, itching, felt like having lump inside her throat, having difficulty swallowing saliva, difficulty breathing and very groggy cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product.  Severe allergic reaction is the known risk for the product. The underlying predisposing condition of allergies to multiple materials may put the patient at high risk of anaphylactic reactions. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
I hadn?t experienced PMR symptoms for 2 years. The evening after my 2nd dose I began experiencing PMR symptoms and have since. The symptoms are manageable and vary in pain level and occurrence. I did get blood tests at my Dr. Office and the results did not warrant prescription treatment.
On 5/31/21 He had a seizure which lasted approximately 2 minutes. Myself (wife) and 2 friends witnessed the whole thing. He complained of being extremely hot and sweating profusely and extremely dizzy. He was unconscious for approx  8 or 9 minutes. I called the paramedics who took vitals and his blood pressure. By the time they got there, he was awake but still on the floor. They found nothing. They told him that his body had to ?reset?, whatever that means. He refused to go to the hospital since it was a holiday and didn?t want to spend the entire day there.
On June 20 of this present year,  I went to a Vaccination room to get 4 doses vaccination here in locally, the fourth dose with the Moderna vaccine, after that I felt normal symptoms after vaccination, but after 2 days the normal pain in shoulder disappeared. But after 5 days I began to feel pain in the arm Joint (elbow), which does not allow me to do my daily activities normally, I have tried to take pain medications, such as paracetamol, dolocordralan, ibuprofen, Diclofenac, Naproxen and Vitamins such as B Complex, etc.
27 April 2003, Single episode of seizure activity (felt to be related to MUFLOQUINE), followed by new onset migraines, fatigue, cognitive changes and vertigo - see attached detailed history.  Patient also feels his infertility may be related to deployment vaccines.  (not discovered until 2008, but fathered last child in 1991).
This case was reported by a consumer and described the occurrence of red bump at injection site in a 4-year-old female subject who was vaccinated with KINRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included seasonal allergy. On 5 August 2014, at 10:15 AM, the subject received unspecified dose of KINRIX (unknown, left leg) which led to a maladministration (vaccine administered at inappropriate site). On 6 August 2012, at 7:30 AM, 1 day after vaccination with KINRIX, the subject experienced red bump at injection site. The reporter's daughter woke up she had a large red bump the size of a quarter on the injection site. The subject's mother put cream/ointment on the bump and it seems to be getting smaller in size and not as red. The subject's mother called the doctor office this morning, and they told her it was normal and just to put it on ice and give ibuprofen. At the time of reporting, the red bump at injection site was improved.
Soft tissue swelling in hands, lips, orbital area and tongue along with recurrent times over the last three weeks starting 2 days after vaccine, treated with Benadryl , cortisone cream and a metrology dose pack, this am half of my tongue is swollen with difficulty swallowing but not an emergent life threatening . My symptoms have not yet resolved and have been recurring
I am hurting so bad in my arm, below my arm, up to my shoulder; I am hurting so bad in my arm, below my arm, up to my shoulder; I really feel sick tonight; I am not feeling too good; I am not feeling well at all; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient had a Pneumonia shot, the patient believe it was Prevnar 13 and the patient was hurting so bad in arm, below the arm, up to the shoulder and the patient really feel sick tonight. Consumer was informed about Medical Information department and was also informed to contact the Physician regarding for the concern. The patient was not feeling too good and was not feeling well at all on an unspecified date. The outcome of events was unknown.  No follow up attempts are possible. Information about the lot/batch number cannot be requested.
Miller Fisher Variant Guillain Barre with ataxia, weakness, ophthalmoplegia.  Patient was treated with 5 days of IVIG therapy and was discharged home in good condition with outpatient PT and near full recovery in 2 weeks.  Has follow up appointment in 1 week from today.
This spontaneous report was received from a registered nurse and refers to an 18 year old female patient with no pertinent medical history or concurrent conditions. On 24-JUN-2015 the patient was vaccinated with a fourth dose of GARDASIL. No adverse effects were reported. The outcome of extra dose administered was unknown. No further information was provided. Additional information has been requested.
Broke out in a rash on entire neck & collar bone (upper part) itched, burning, stinging for about 2 wks, better now, rash seems to have cleared up. Had headaches, also better.
Pt received VARIVAX & eyes on 5-29-08 4pm 10:45 pm-worsening rash, cough, sore throat, some disorientation. Mom took into steaming shower, gave diphenhydramine with good effect; F/u here 5-30-08- Sx's have resolved.
Extensive skin rash in right arm. I started on my own treatment with Cephadroxil  Hydrocortisone Cream and cold pads.
25 minutes after injection, my nose, the skin between my lip and nose, and my upper lip went numb. My tongue also felt less sensation- and minor swelling on my upper lip/nose. Ringing headache in ears. No issues with breathing or swelling in mouth
Severe hives 3 days after shot. 7 days fever 103, chest congestion, sore throat, head cold, weakness, sweating, no energy, lasting 3 wks joint soreness still ongoing.
This spontaneous report as received from a registered nurse refers to a 20 week old patient (gender unspecified). The patient received the first dose of ROTATEQ on 20-MAR-2013 at 20 weeks of age. Lot# and administration route were unspecified. No adverse symptoms reported. It was unspecified if the patient sought medical attention or not. Additional information has been requested.
having a heart attack; having a panic attack; nervous person; Feeling sick; might throw up; This spontaneous case was reported by a consumer and describes the occurrence of ANGINA PECTORIS (having a heart attack), PANIC ATTACK (having a panic attack), NERVOUSNESS (nervous person), MALAISE (Feeling sick) and VOMITING (might throw up) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939904 and 017Moderna) for COVID-19 vaccination.     Concurrent medical conditions included Disability.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ANGINA PECTORIS (having a heart attack), PANIC ATTACK (having a panic attack), NERVOUSNESS (nervous person), MALAISE (Feeling sick) and VOMITING (might throw up). At the time of the report, ANGINA PECTORIS (having a heart attack), PANIC ATTACK (having a panic attack), NERVOUSNESS (nervous person), MALAISE (Feeling sick) and VOMITING (might throw up) outcome was unknown.            No concomitant medication reported.  No treatment information was provided.  Patient states that all these symptoms are being triggered by the stressful situation of having lost the information of her second dose   Company Comment: This case concerns an adult female patient of unknown age, with no medical history, who experienced the unexpected events of Angina pectoris, Panic attack, Nervousness, malaise and the expected event of Vomiting. The events occurred on an unknown date after the third dose of mRNA-1273 Vaccine. At the time of the report the outcome of the events was unknown. The rechallenge is not applicable since no further dosing is expected. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This case concerns an adult female patient of unknown age, with no medical history, who experienced the unexpected events of Angina pectoris, Panic attack, Nervousness, malaise and the expected event of Vomiting. The events occurred on an unknown date after the third dose of mRNA-1273 Vaccine. At the time of the report the outcome of the events was unknown. The rechallenge is not applicable since no further dosing is expected. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored LIQUID PEDVAXHIB Lot#K02500 and K015462 (dose was not reported). No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.