chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Her face drooping on one side/when brushing teeth water dribbled out of side of her mouth/ Bell's palsy; Her jaw locked up, when / she could not open her mouth wide enough to eat; Her tongue felt like it was burnt and her food tasted funny; Her tongue felt like it was burnt and her food tasted funny; Her neck hurt; This is a spontaneous report from a contactable consumer (Patient herself). A 53-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 20May2021 (at 53-years age) as 2nd dose, single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 26May2021 a week after the vaccination patient experienced her tongue felt like burnt and her food tasted funny, and face still felt funny, her neck hurt. On 29May2021 her jaw locked up, when brushing teeth water dribbled out of side of her mouth, she could not open her mouth wide enough to eat. On next day 30May2021 her son noticed that patient's face drooping on one side called 911. She thought she was having a stroke but at the hospital said she had Bell's Palsy. The doctor at the hospital stated it was one of the side effects of the shot. The patient started to take 60mg of Cymbalta and .37mg of Synthroid daily as a treatment to event. The outcome of the events was unknown.
Patient called 2/2/2018 reporting severe pain to arm at injection site and radiating to shoulder and all of the left upper extremity. Pain was mild on day of injection and became increasingly worse (interfering with daily activities), reaching a plateau on 2/1/2018 and then continually decreasing. Client denied any swelling, edema, numbness, tingling, or loss of dexterity to area affected. This nurse reviewed Table 1 of GARDASIL insert regarding severe pain as injection site adverse reactions for her age group and sex. Patient reports some relief of pain with ibuprofen and cold compresses. She declines to seek care of medical provider.
This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 72-year-old female patient who received SHINGRIX for prophylaxis. On 7th November 2018, the patient received SHINGRIX. On 8th November 2018, 1 days after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling and pain in hand. On an unknown date, the outcome of the injection site erythema and injection site swelling were recovering/resolving and the outcome of the pain in hand was not recovered/not resolved. It was unknown if the reporter considered the injection site erythema, injection site swelling and pain in hand to be related to SHINGRIX. Additional details were provided as follows: The patient received the SHINGRIX on right arm. The patient experienced redness, swelling and pain at the injection site the morning after getting the vaccine. The pain progressed to the inside of the right arm and down to the elbow. It then went into the wrist and hand. The pain traveled down in was a gradual progression and had been in the hand for approximately a week at the time of reporting. The redness and swelling had improved and were almost gone but the pain was still present at the reporting time. The reporter gave consent to follow up.
where RUQ tenderness was noted on exam; BILI was 1.1; C-reactive protein (CRP) 25.8; She had persistent circulation sxs in her feet/ persistent Raynaud's type sxs primarily; her toes felt numb; patient noticed her toes felt numb, looked purplish; patient noticed her toes felt numb, looked purplish, and were cold; fever > 101 with chills and myalgias; fever > 101 with chills and myalgias; fever > 101 with chills and myalgias; This is a spontaneous report from a contactable Physician. A 38-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 38-year-old, via intramuscular on 05May2021 as single dose for COVID-19 immunisation.  Medical history included morbid obesity, fibromyalgia, Post-traumatic stress disorder (PTSD), Anxiety, Attention deficit hyperactivity disorder (ADD), depression, prehypertensiony. Known allergies: cefixime (FLEXERIL), tape. The patient previously received the first dose of BNT162B2 on 14Apr2021 at the age of 38-year-old, for COVID-19 immunization. Concomitant medications included bifidobacterium infantis (ALIGN); ergocalciferol (VIT D); iron; magnesium. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  Clinical course: On 19May2021 the patient noticed her toes felt numb, looked purplish, and were cold.  She took a shower, then spiked a fever > 101 with chills and myalgias. 48 hours later her fever was improved and she went for a COVID test (on 21May2021), which was negative. She had persistent circulation sxs in her feet. The reporter saw her on office on 25May2021, where RUQ tenderness was noted on exam. Labs were significant for white blood count (WBC) 8.0 with normal difference, Blood albumin (ALB) 3.3, Blood bilirubin (BILI) 0.3, C-reactive protein (CRP) 25.8, Red blood cell sedimentation rate (ESR) 54, normal Urine analysis (UA), Antinuclear antibody (ANA) 1:80 with a cytoplasmic pattern, neg cascade. Ultrasound abdomen (Abd U/S) was negative. Repeat labs 03Jun2021 her CRP was now 9.3 and BILI was 1.1, otherwise negative CBC and CMP.  Patient seen 08Jun2021 with persistent Raynaud's type sxs primarily. Repeat labs pending at the time of this report. The events were reported as non-serious. No treatment received for the events. The events resulted in physician office visit. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Case number PHEH2013US021748 is an initial spontaneous report received from the health care professional on 16 OCT 2013. This report refers to an 11-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with initial dose of MENVEO (batch number: A11082) at a dose of 0.5 ml intramuscularly in the right deltoid on 10 MAY 2013 at 09:15 AM. It was reported that the patient received vaccine which was compromised due to refrigeration malfunction (temperature error). He was re-vaccinated on 16  AUG 2013. No  adverse event was experienced following this a administration error (incorrect storage of drug).
Zoster up left arm and upper back developed over several days - treated 01/20/2005 with Zovirax
breakthrough covid infection; covid infection after first 2 doses of moderna; This spontaneous case was reported by a physician and describes the occurrence of INFECTION (breakthrough covid infection) and COVID-19 (covid infection after first 2 doses of moderna) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFECTION (breakthrough covid infection) and COVID-19 (covid infection after first 2 doses of moderna). At the time of the report, INFECTION (breakthrough covid infection) and COVID-19 (covid infection after first 2 doses of moderna) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  Company comment: This case concerns a patient of unknown age and gender, with no medical history, who experienced the unexpected non serious events of infection and COVID 19. The events occurred on an unknown date after the second dose of mRNA-1273. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a patient of unknown age and gender, with no medical history, who experienced the unexpected non serious events of infection and COVID 19. The events occurred on an unknown date after the second dose of mRNA-1273. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report.
PATIENT WAS IN AND OUT OF CONSCIOUSNESS.  NO SIGN OF ALLERGIC REACTION,ITCHING OR RASH OR SOB.  WAS WORRIED ABOUT HER AND CALLED EMS.
Pulmonary Embolism 27 year old female presented to ED with chest pain and shortness of breath that began within 24 hours of receiving second Covid vaccine injection on 1/29/21. Chest pain subsided with Tylenol and time, but shortness of breath persisted, worsening on 2/8/21 which brought patient to ED. CTA confirmed PE diagnosis and treated with out patient oral therapy - Xarelto.
Bells Pallsey event Left arm, face, tongue numbness and tingling, slurred speech,  no left facial movement Last approximately 1hr 1/2 then full function returned
Mother reported that pt had a low grade fever, very fussy and inconsolable, her eyes buldged and became stiff, then her eyes fluttered a little (she described this as a seizure). Some swelling to the R thigh.
This spontaneous report as received from a nurse practitioner refers to a 20 year old unspecified patient. On 16-MAR-2014, the patient was vaccinated with first dose of RECOMBIVAX HB Intramuscular Injection, that was 5 microgram (mcg) in strength, intramuscular. Concomitant medication was unspecified. Nurse practitioner also mentioned that the unspecified patient had a blood titer drawn (on an unknown date) and it was negative for antibodies. No product quality complaint was involved. Outcome of th e event was unknown. No further information was provided. Additional information is not expected.
Chills; Fever (101 deg F); Tiredness; The patient received booster/ third dose of BNT162B2; This is a spontaneous report from a non-contactable consumer, the patient. A 55-year-old female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2589) via an unspecified route of administration on 11Nov2021 at 18:30 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. It was reported that patient did not know if she had any allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration on 17Mar2021 (at the age of 54-years-old) and received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration on 07Apr2021 (at the age of 54-years-old) as a single dose for covid-19 immunisation. On 12Nov2021 the patient experienced chills, fever (101 degrees Fahrenheit) and tiredness. On the same day, the patient underwent body temperature test and the result was 101 degrees Fahrenheit. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, fever and tiredness was unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
Immediately had headache with an odd "kaleidoscope" vision around a central dark floater in his visual field.  worsened into a very intense headache, high fever (102F) and rigors. Next few days bad arthralgia. By Day 4 everything had resolved except a persistent "small dark rectangle" visual deficit which has persisted.
Pt recvd 3 doses of Hep B vax; 3rd dose was Engerix-B given 8AUG90; It was determined that the pt was not immune to Hep B;
sore left injection site arm.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left injection site arm.) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced VACCINATION SITE PAIN (sore left injection site arm.). At the time of the report, VACCINATION SITE PAIN (sore left injection site arm.) outcome was unknown.      Concomitant medications was not provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2022-546515, MOD-2022-546520 (Patient Link).
I had sudden onset of a rapid heart rate, it started at 170 and went up. I called an ambulance and was admitted and I also had a fever of 101.  I was discharged 3 hours later and advised to seek care from a cardiologist. On my discharge paperwork it shows diagnoses of Supraventricular tachycardia and severe adverse event to COVID-19 vaccine. I have pending appointments with a cardiologist and my primary care physician.
like I've got the flu; sick to my stomach; muscle aches & pains; joint aches & pains; chills; nausea; This spontaneous case was reported by an other health care professional and describes the occurrence of INFLUENZA LIKE ILLNESS (like I've got the flu), ABDOMINAL DISCOMFORT (sick to my stomach), MYALGIA (muscle aches & pains), ARTHRALGIA (joint aches & pains) and CHILLS (chills) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (like I've got the flu), ABDOMINAL DISCOMFORT (sick to my stomach), MYALGIA (muscle aches & pains), ARTHRALGIA (joint aches & pains), CHILLS (chills) and NAUSEA (nausea). At the time of the report, INFLUENZA LIKE ILLNESS (like I've got the flu), ABDOMINAL DISCOMFORT (sick to my stomach), MYALGIA (muscle aches & pains), ARTHRALGIA (joint aches & pains), CHILLS (chills) and NAUSEA (nausea) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment details were reported. It was reported that the events were Improved. It was unknown if the patient had ever tested COVID positive. Information on other vaccines given within one month prior to Moderna vaccine was unknown. Patient did not seek medical care due to Adverse events. Information on a similar events experienced by patient in the past was unknown.   This case was linked to MOD-2022-573328, MOD-2022-573336, MOD-2022-573339 (Patient Link).
c/o redness around the inj site w/itchiness poss cellulitis;given ATB;
Woke up in the next morning at 8am feeling feverish, injection site was red and warm to touch with a fever peaking in evening to 101.3 F. Midday symptoms progressed to feeling achy (flu-like symptoms). May 24th, fever subsided, Pt had an appt with dr and md prescribed prednisone and antibiotic for symptoms of the shot. Pt did not fill bc he started feeling better as day went on. May 25th, pt felt better after much rest May 26th, felt almost asymptomatic.
Sore arm; Shortness of breath; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 13Apr2021 at 12:00 (at the age of 64-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. The patient did not receive any other vaccines within two  weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 23Mar2021 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. On 14Apr2021 at 00:30 the patient experienced, sore arm and shortness of breath. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sore arm and shortness of breath was recovered on 14Apr2021.  No follow-up attempts are needed. No further information is expected.
Fever, chills, headache for 1.5 days, fatigue for first shot. Second shot joint pains, fatigue, headache for 14+ days
herpes simplex keratitis causing corneal decompensation; This is a literature report.  An 82-year-old female patient received BNT162b2 (BNT162B2), on 07Feb2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "open-angle glaucoma" (unspecified if ongoing); "uveitis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: OPHTHALMIC HERPES SIMPLEX (medically significant) with onset 14Feb2021, outcome "recovered", described as "herpes simplex keratitis causing corneal decompensation". The patient underwent the following laboratory tests and procedures: examination: she had a significant decrease in her vision from, notes: baseline in her left eye; Slit-lamp examination: she was found to have corneal edema, notes: with Descemet folds as well as microcystic edema. Therapeutic measures were taken as a result of ophthalmic herpes simplex. Clinical course: An 81-year-old woman with a past ocular history significant for open-angle glaucoma as well as uveitis presented with severe pain and decreased vision in her left eye 1 week after receiving her first dose of the Pfizer COVID-19 vaccine. On examination, she had a significant decrease in her vision from baseline in her left eye. On slit-lamp exam, she was found to have corneal edema with Descemet folds as well as microcystic edema. She had no signs of iritis. The patient was diagnosed with herpes simplex keratitis causing corneal decompensation and was started on valacyclovir as well as topical prednisolone. The diagnosis was made based on her acute presentation and history. In follow-up visits at 2, 4, 8, and 12 weeks, the patient showed no improvement despite medical management. She was not on any prostaglandin analogues leading up to or during this period. Due to unresolving vision loss that was affecting the patient's functioning, a Descemet stripping automated endothelial keratoplasty was successfully performed 3 months after the onset of symptoms. At post-op month #1, the corneal transplant was clear, and the patient's vision improved.; Sender's Comments: Based on the available information and the known product safety profile, a causal relationship between the reported event ophthalmic herpes simplex and BNT162B2 is considered possible. 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.,Linked Report(s) : US-PFIZER INC-PV202300145291 Same article/ drug/event and different patient;
I started to have sinus symptoms and I had a little bit of a cough. I was congested and I thought my Asthma was acting up. I thought I had a Sinus Infection. I tested positive for COVID-19 on 10/01/2021. I went to get tested because I had no sense of taste two hours after I ate lunch which I could taste. I tested positive right away. The next day I felt awful. My sense of smell came back first at five days. I could not taste anything for about 10 days. My coughing got worse and I had a severe headache for a few days. I did not have a fever the whole time. I used Tylenol and Motrin but I did not spread it to the rest of my family. I still have a lingering cough and brain fog after three weeks. The brain fog started during my quarantine; I could not concentrate on reading. I could not remember things I had read repeatedly.
Immunization given 10-19-06.  Child begin summary running fever 10-20-06.  Had febrile x1-went to ER. Gave Motrin and sent home.  Alternated tylenol with motrin-went back to ER Sun 10-22-06. Diagnosed with kidney infection, ear infection.  Took Bactrim, had allergic reaction.  Left deltoid red. No further problems noted.
TINGLING OF THE LEFT LEG; SWELLING; SORENESS AT INJECTION SITE; This spontaneous report received from a patient concerned a 42 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included no alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no drug abuse or illicit usage of drugs. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808982 expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced soreness at injection site. On 12-APR-2021, the subject experienced tingling of the left leg. On 12-APR-2021, the subject experienced swelling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tingling of the left leg, and swelling, and the outcome of soreness at injection site was not reported. This report was non-serious.
Adult client given pediatric Hepatitis B vaccine. Contacted state immunization dept. who advised to contact client to return same day if possible and given second dose to make full adult dose. Client contacted; returned to clinic; situation explained; consented and given second pediatric dose. Age of patient at time of event: 36 years.
Headache Narrative: employee states that she has been experiencing severe headaches since vaccination whish she has not previously experienced.
Sudden onset of swelling of upper lip and swelling and bruising of feet and ankles. Few hours later developed red raised irregular itchy rash in groin area. Tenderness of his feet developed. Child was seen in ED. Symptoms started when they were traveling.