chrisvoncsefalvay/vaers-outcomes huggingface dataset:
septic; did not know who she was or where she was; missed second dose; acting like she had a stroke; feeling ill; This spontaneous case was reported by a consumer and describes the occurrence of SEPSIS (septic) and DISORIENTATION (did not know who she was or where she was) in a 79-year-old 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 was provided by the reporter.  Concomitant products included LEVOTHYROXINE, CARBIDOPA, LEVODOPA (CARBIDOPA/LEVODOPA), PREDNISONE and VITAMINS NOS for an unknown indication.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced DISORIENTATION (did not know who she was or where she was) (seriousness criterion hospitalization) and VACCINATION COMPLICATION (feeling ill). On 25-Jan-2021, the patient experienced ABNORMAL BEHAVIOUR (acting like she had a stroke). On an unknown date, the patient experienced SEPSIS (septic) (seriousness criteria hospitalization and medically significant) and PRODUCT DOSE OMISSION ISSUE (missed second dose). The patient was hospitalized on 25-Jan-2021 due to DISORIENTATION and SEPSIS. At the time of the report, SEPSIS (septic), DISORIENTATION (did not know who she was or where she was), PRODUCT DOSE OMISSION ISSUE (missed second dose), VACCINATION COMPLICATION (feeling ill) and ABNORMAL BEHAVIOUR (acting like she had a stroke) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided by the reporter. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Upper legs have broken out into hives about 24 hours after vaccination and has been persistent and itching has gotten worse in the last 24 hours.  Treatment: A hydrocortisone cream
8:30PM devel redness on face, itchy throat & cough also swelling of lips;
1 day after the injection the injection site was red, warm and raised. Swelling then decreased. 1 week after injection the site worsened, increased swelling, redness, warmth, and itching.
Vaccine breakthrough, symptomatic.   Inpatient admit 9/21 to present,
Initial report received on 10 December 2009 from a consumer. A 42 year old female patient with a history of CROHN'S disease (treated with mercaptopurine) developed muscle pain in her right thigh six days after receiving a right deltoid intramuscular dose of Influenza (H1N1) 2009 Monovalent Vaccine (lot number UP002AA). The day after the muscle pain began, the patient developed twitching in her legs which became widespread, including her lips. The patient also complained of pins and needles in her feet and other locations on her body. The patient went to the neurologist and was diagnosed with neuropathy. Blood work and nerve conduction study were completed, however the results were not provided. The patient was reported as not recovered. List of Documents held by the Sender: none.
Swollen face, tiredness, headache, muscle pain, nausea, feeling unwell, Swollen lymph node and vomiting
This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4316080-00 (RA). A 55 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 28Feb2022 (Batch/Lot number: unknown) at the age of 55 years as dose 4, single, intramuscular, administration date 03Sep2021 (Batch/Lot number: unknown) as dose 3 (booster), single, intramuscular, administration date 24Jun2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 24May2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Lot number: 1159243) till 07Mar2022 for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BURNING SENSATION (hospitalization), outcome "unknown", described as "hands are burning again"; BLOOD GLUCOSE ABNORMAL (hospitalization), outcome "not recovered", described as "blood sugar over 400"; DRUG INEFFECTIVE (hospitalization), outcome "unknown", described as "Humira alone dose not work". The patient underwent the following laboratory tests and procedures: blood glucose: over 400. The action taken for adalimumab was dosage permanently withdrawn on 07Mar2022. The reporter did not stated any reasonable causal relationship between Humira and the following events: Lack of drug effect, Blood sugar abnormal and Burning sensation of upper limb. The manufacturer stated that there is no reasonable possibility of causal relationship between Humira and the following events: Blood sugar abnormal and Lack of drug effect. The reporter stated that there is a reasonable possibility of causal relationship between BNT162b2 and the following events: Lack of drug effect, Blood sugar abnormal and Burning sensation of upper limb. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on the currently available information the possibility of causal association between the events Blood sugar abnormal, Burning sensation of upper limb and the suspect drug BNT162B2 cannot be ruled out. Lack of drug effect (Humira) is assessed possibly unrelated to suspect drug BNT162B2. The case will be reassessed once new information is available. 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
metallic taste; salivating black; tongue is stained black; This is a spontaneous report from a contactable consumer (patient herself). A 47-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) intramuscular on the left upper arm on 04Mar2021 at 14:00 (at the age of 47-year old) (Batch/Lot number EL9264) at single dose for Covid-19 immunization. Relevant medical history included allergy to doxycycline described as vomiting from in 1990s or 1990. Concomitant medications were not reported. Starting about 07:45 on 05Mar2021 when she woke up she had a metallic taste in her mouth; she began salivating black, spitting up black saliva which turned her tongue black, tongue was stained black in stripes. She still had the metallic taste in the back of her throat; but was not actively spitting up black saliva any longer. The outcome of metallic taste was recovering, the outcome of other events was unknown.  No follow-up attempts are possible. No further information is expected.
pt recvd vax in AM; presented in facility w/in 60 mins of vax being administered w/nausea, vomiting & marked lethargy; epi & Phenergan given; had bilateral wheezing;
Patient reports getting first COVID vaccine on 6 Feb.  She got her second COVID Pfizer vaccine on 27 Feb.  The next day, she developed a rash to both lower extremities.  It is itchy and sun sensitive.  She did have hundreds of tiny blisters on her feet and legs.  Her rash was red.  Her rash improved a little when I saw her and was not as severe.  It partially blanches.  Rash appears like vasculitis without purpura.  We have a picture in our medical record.
Breakthrough case admission after 2 vaccines Pfizer 9/21/21 lot# FC3183;  Pfizer 10/12/21 lot# FF2589
Dysautonomic reaction when treated with mRNA 1273 (Dose 1); This spontaneous case was reported by a consumer and describes the occurrence of AUTONOMIC NERVOUS SYSTEM IMBALANCE (Dysautonomic reaction when treated with mRNA 1273 (Dose 1)) 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, the patient experienced AUTONOMIC NERVOUS SYSTEM IMBALANCE (Dysautonomic reaction when treated with mRNA 1273 (Dose 1)). At the time of the report, AUTONOMIC NERVOUS SYSTEM IMBALANCE (Dysautonomic reaction when treated with mRNA 1273 (Dose 1)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported No treatment medication reported  It was reported that on 05-DEC-2021 patient received covid-19 vaccine ad.26. cov2,s.(Janssen).  Dose number, route of administration and batch number was not reported. Indication was reported as prophylactic vaccination. Action taken with drug was reported as not applicable and dechallenge and rechallenge  also not applicable.  Patient reported that on 05-Dec-2021 had lab test includes heart rate increased (225).  Patient had adverse event after Janssen vaccine included woke up with heart rate of 225 (recovering/resolving), mild chest pain (not recovered), entire body cold (recovering/resolving) and entire body numbness (recovering/resolving).  Reporter and company causality for Janssen vaccine was reported as possible.
Patient developed a severe case of zoster on her lower extremity, then a disseminated rash.
I received my second dose of Pfizer on 4/23/2021. Early in the afternoon on 4/24/2021, I started having cardiac arrhythmias, which lasted for about 6 hours. I had never had this happen before. My only previous experience with palpitations was the occasional single palpitation following standing in one place or not having had enough water.
buzzing in ears/tinnitus; light-headedness/dizziness; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727) via an unspecified route of administration in the right arm on 25Mar2021 at 18:45 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, blood pressure high and depression. Concomitant medications included metformin (MANUFACTURER UNKNOWN), valsartan (MANUFACTURER UNKNOWN), pantoprazole (MANUFACTURER UNKNOWN) and thyroid (ARMOUR THYROID) taken for unknown indication and unknown if its ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202) via an unspecified route of administration in the right arm on 03Mar2021 at 18:45 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. The patient previously received amoxicillin (AMOXYL) taken for unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 07:00, about 2 weeks after second dose of the vaccine, the patient woke up and had a buzzing in her ears as well as light-headedness/dizziness. It happened constantly and have never had issues with tinnitus or dizziness before but this was non-stop. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events buzzing in ears/tinnitus and light-headedness/dizziness were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
12-12-2022:  presented with SOB   Hazard ARH  + for covid.  also   cough, headache, chills,   oxygen sat of 88-89 % on Room air.  remdesivir and covid protocol started.  cefepime also given.  increased hypoxia  12/15 requiring vapotherm. transferred to ICU  , cxr now showing bilateral infiltrates.  BARICI started.  12/16 cxr : ground glass opacity c/w ARDS due to covid.  Hypoxia worsened started on AVAPS.    12/18/22 started improving and was discharged home 12/24/22  with oxygen.   To local hospital 12-29-22 with shortness of breath.  CXR showed bilateral pneumonia, given vancomycin and zosyn and decadron and covid 19 supplements and albuterol.   Patient requested to be DNR status.  on 12-31-22 he passed away with diagnosis of  Acute Respiratory Distress Syndrome due to covid and acute hypoxic resp failure and bacterial pneumonia
1 day p/vax in lt arm-arm was sore &  had an area of erythema & edema larger than a silver dollar @ the site of the inj;applied cortisone cream & now is better still some erythema & itching @ the inj site;
Patient has no reported adverse reactions at this time. Pt. received the vaccine in May 2021, signed consent that he had not had it, and received it again on 7/28/21.
Admitted for dehydration and orthostatic hypotension. COVID positive. Fully vaccination in March 2021.
acute demyelinating polyneuropathy-GBS onset 3wk p/vax; supportive care/rehab;
68 yo male presented 10/8/2021 for atypical chest pain consisting of chest pain worse with leaning forward to tie his shoe but better with standing. When asked patient thought initially that Pfizer shot #3 was around the same time, but later looked at calendar and does think he got the shot a few days prior to onset of the chest pain. He received it 9/27/2021 and has a not on his calendar of starting to have pain around 10/4/2021.  ECG though and labs including CRP were normal though our cardiologist thought history still concerning  for pericarditis and recommended echo which is pending. patient also had taken ibuprofen already which had helped and has continued ibuprofen with near resolution of symptoms now
Information has been received from a medical technologist concerning a middle aged female who was vaccinated with a dose of hepatitis B virus vaccine rHBsAg (yeast).  The reporter indicated that the pt complained of a "funny feeling" in the liver after vaccination.  The reporter noted that the pt had negative titers for hepatitis B virus and hepatitis C virus.  Unspecified medical attention was sought.  A product quality complaint was not involved.  Additional information has been requested.
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Medium, Systemic: Hyperventilation-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: During observation period, Patient had a fluttering sensation in chest, tingleing in chin/neck. She appeared flushed and speech became slow. Took pulse and blood pressure readings which were elevated but not concerning. However, tingling spread to arms and legs and mental confusion persisted. Team called 911 and patient rode in ambulance to ER. Patient reported that ER doctor said reaction was likely because she had Covid only a few weeks ago, which was not reported prior to immunization.
This spontaneous report was received from a female patient of unspecified age, referring to herself. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On unspecified dates, the patient received three shots of unidentified Merck HPV vaccine intramuscular injection (name and lot number were not reported) for prophylaxis of human papilloma virus (HPV) infection. Patient reported that she did not know if the vaccine was GARDASIL or GARDASIL 9. She reported that while receiving the third shot of vaccine her physician used a larger needle and a bigger vial (drug administered in wrong device). She mentioned that she thinks the last shot was administered incorrectly (wrong technique in product usage process) and an incorrect dosage was administered. She developed pain and swelling at the injection site. Patient reported that she contacted doctor's office but no one answered her questions. No treatment was provided for the adverse events. Outcome of the events, pain and swelling at injection site was reported as not recovered. Causality assessment was not provided. Additional information has been requested.
Out of body, heart palpitation, extreme depression & anxiety. Chills/sweats. Fear of dying. Feeling that I'm on a mind altering drug. Feel the need to urinate, but didn't need to. Doctors say I had a panic attack for bout 30 mins. The next 3 months I had these episodes on a daily basis, doctors were calling them panic attacks. I have no history of panic attacks or anything mentioned above. The attacks stopped after 3 months but the palpitations never stopped, I have them all day everyday.
Within 5 minutes of receiving the 2nd Covid vaccine, my daughter started having a headache and blurry vision. She was seated at the time these complaints started. She then began staring into space and would not acknowledge me when I called her name. Next, her body contracted (legs tightened and went underneath the chair). She screamed. I caught her body as she slid out of the chair. I moved her to the ground. Her eyes were open and fixed. Pupils were normal in size. Skin was normal in color. No sweating noted. There was no sign of respiratory or cardiac distress. She was unresponsive for 2-3 minutes, but eyes were open and fixed. When she became responsive, she did not remember anything that happened or how she had gotten to the floor. She reported a "huge ball in her stomach." We remained at the facility for one hour following her vaccination. We contacted her doctor that afternoon. They encouraged us to continue monitoring her at home. The remainder of the afternoon and evening she was fine. The next day (Saturday) she was extremely lethargic. She could barely hold her eyes open and she would crawl whenever she needed to get up from the couch to go to the bathroom or kitchen. She ran a fever of 100. 3 degrees F. We administered Tylenol times 2 doses that day. The following day, Sunday, she was fine. Then on Monday, she developed severe abdominal pain followed by diarrhea and vomiting. She had one occurrence of diarrhea and vomiting that day. The following day, Tuesday, she was fine. We stayed in contact with her doctor during this time. We followed up with a visit to discuss this event with her pediatrician. We are uncertain exactly what happened following our daughter's vaccination, but we believe it may have been a vasovagal response. Together, with our pediatrician, we decided to file this report in case other similar instances have occurred.
Nausea starting at noon on 5/17/2021. Vomiting grade 1/2 at 1AM 5/18/2021. Fatigue/lethargy/lack of appetite throughout.
Sudden onset gallbladder attacks and sludge and stones being present in the gallbladder with multiple ER visits for attacks, which eventually led to removal of my gallbladder, and then a sudden onset in severity of my stomach issues which was later diagnosed as delayed gastric emptying.
Felt "yicky"; Dizzy; Felt similar to when she was pregnant; Threw up; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FEELING ABNORMAL (Felt "yicky"), DIZZINESS (Dizzy), MALAISE (Felt similar to when she was pregnant), VOMITING (Threw up) and FATIGUE (Fatigue) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced FEELING ABNORMAL (Felt "yicky"), DIZZINESS (Dizzy), MALAISE (Felt similar to when she was pregnant), VOMITING (Threw up) and FATIGUE (Fatigue). At the time of the report, FEELING ABNORMAL (Felt "yicky"), DIZZINESS (Dizzy), MALAISE (Felt similar to when she was pregnant), VOMITING (Threw up) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment information were not provided.; Sender's Comments: Based on the current available information which includes a temporal association between the use of mRNA-1273 and the start date of the reported events, a causal relationship with the event cannot be excluded. Fatigue and vomiting are consistent with the known safety profile of the vaccine.
This spontaneous report as received from a pharmacist refers to an approximately 67 year old female patient. The patient's medical history included Knee replacement (right) (knee arthroplasty). There was no drug reactions or allergies reported. On 17-JUL-2015 the patient was vaccinated with ZOSTAVAX (lot # L011535, expiry date 03-JUL-2016) 0.65 ml, subcutaneously (dosing regimen and frequency unknown). No concomitant medications were reported. On an unknown date approximately in July 2015 the patient experienced inflammation in her right knee (arthritis). It was reported that the patient sought medical attention and saw a physician who prescribed a MEDROL pack. No lab diagnostics studies were performed. The patient was treated with a MEDROL pack for the event. The action taken with the therapy with ZOSTAVAX was unknown. The outcome of arthritis was unknown. The relatedness of the events to the therapy with ZOSTAVAX was unknown. There was no product quality complaint reported. Additional information has been requested.
The following day also had a nose bleed; Scratchy throat; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 22Apr2021 at 09:45 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to nuts, allergy to shrimp and penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included mometasone furoate (NASONEX), cetirizine hydrochloride (ZYRTEC), ciclesonide (ALVESCO) and vitamins; all taken on unknown date for unknown indication and unknown if ongoing. The patient previously received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 01Apr2021 at 09:45 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 22Apr2021 at 10:05, after receiving the second vaccine, the patient started to develop a scratchy throat 20 minutes after the injection that lasted the entirety of the day, and on the following day, 23Apr2021, the patient also had a nose bleed. The patient did not receive any treatment for the events. The events did not result in any of these 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. No therapeutic measures were taken for the reported events. The clinical outcome of the events scratchy throat and nose bleed was recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.