chrisvoncsefalvay/vaers-outcomes huggingface dataset:
unrelenting itchiness all over her body for 2 days; soreness at the injection site; overwhelming sleepiness for quite a few hours after the vaccine; tired; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246, expiration date: unknown), intramuscular (right upper arm) on 05Jan2021 at 11:45 at a single dose for COVID-19 immunization. Medical history was not reported. There were no concomitant medications. It was also reported that she had 2 shots in polio season in 1952 and did not go back for the booster. The patient had no prior vaccinations (within 4 weeks) following prior vaccinations. The patient had symptoms after the first dose of the COVID-19 vaccine, on 05Jan2021. Symptoms are as follows: soreness at the injection site, overwhelming sleepiness for quite a few hours after the vaccine. On 06Jan2021, the patient then had unrelenting itchiness all over her body for 2 days. The patient wanted to know if she can get the second dose, and if the second dose is stronger. She stated that she used to be 5ft 6in and stated that she still says that and did not want to confess that she is shrinking. She said that she took a 4-hour nap and was still tired and then took another hour nap. About 5 hours later, she was still tired and went to bed and slept until the morning. She stated that she normally goes to bed around 3am anyway and she had plenty of sleep that day. She said that she does not sleep all day and does not fall into a stupor. She received the injection on 05Jan2021. She said that she touched the injection site and she felt the soreness a few hours after receiving the injection. She clarified it was 5-6 hours after receiving the injection. She does not know the date when it went away. She said that she did not touch it again. The patient also said that she does not usually itch anyway herself; the itching went into the next day and was centered around the navel. The patient also said that she is no longer experiencing the symptoms that appeared. The patient also checked temperature with unknown results. The event soreness at the injection site and tired resolved in Jan2021, overwhelming sleepiness for quite a few hours after the vaccine resolved on 06Jan2021 while the event unrelenting itchiness all over her body for 2 days resolved on 07Jan2021.
Coughing fit; Burning in chest and on breasts which felt like jalepeno had been rubbed all within lungs and on breasts.; Burning in chest and on breasts which felt like jalepeno had been rubbed all within lungs and on breasts.; So uncomfortable; Breasts was very red and streaky; Rashes; Skin inflammation; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 20Apr2021 at 09:30 (at the age of 38-years-old), as a single dose for COVID-19 immunisation. Medical history included allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included fexofenadine hydrochloride (ALLEGRA) and multivitamins (MANUFACTURER UNKNOWN); both from unknown dates for unspecified indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 30Mar2021 at 11:00 (at the age of 38-years-old), as a single dose for COVID-19 immunisation. On 20Apr2021 at 12:00, within about 2 hours after the vaccination, the patient experienced coughing fit (which the patient had already been having due to allergies). The patient had a burning in chest and on the breasts which felt like jalepeno had been rubbed all within lungs and on the breasts. The patient was so uncomfortable. It was reported that the patient stripped down and saw that the breasts were very red and streaky. The coughing and burning sensations have occurred 4 times, but the patient had not noticed any more rashes or skin inflammation. The patient's left side was definitely more affected than the right. 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 coughing fit, burning in chest and on breasts which felt like jalepeno had been rubbed all within lungs and on breasts, so uncomfortable, breasts was very red and streaky, rashes and skin inflammation were unknown at the time of reporting.    No follow-up attempts are needed. No further information is expected.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown).  The patient's concurrent conditions, medical history and concomitant medication use were not provided.  In 2014, the patient was administered ZOSTAVAX, 1DF, (lot# and route unknown), at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of shingles. On or about 10-OCT-2016 the patient was treated by a Physician Assistant for complaints of radiating and burning pain on her ribcage and back, which was diagnosed as severe herpes zoster, or shingles. The patient has been prescribed gabapentin for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient has suffered and will continue to suffer significant medical expenses, lost wages, pain and suffering, and other damages.  Additional information has been requested.
Inj site red and hot swollen, itchy still there today, 2/1/21.
Information has been received from a physician concerning a 58 year old female who on 16-NOV-2009 was vaccinated with a dose of PNEUMOVAX 23 (LOT# 664864/1365Y). Secondary suspect vaccination included an unspecified "seasonal flu vaccine" (name and manufacture unknown) which was received on the same day on different arm. On unspecified dates, the patient experienced symptoms like redness and swelling where the PNEUMOVAX 23 was given and also experienced headache, fever and nausea. Unspecified medical attention was sought and the patient's outcome was unknown. Follow up information has been received from the physician concerning this patient. It was confirmed that the patient received on 16-NOV-2009 a dose of PNEUMOVAX 23 (Lot # 664864/1365Y), IM, right deltoid, and a dose of FLUZONE, IM, left deltoid. Concomitant therapy included ALDACTAZIDE, verapamil, lorazepam, tiotropium bromide and PROVENTIL. The patient experienced on 17-NOV-2009 redness, vaccine site swelling, headache, fever and nausea. The patient recovered on unspecified date from all the adverse events. Additional information is not expected. This is one of the two reports from the same source.
19NOV91 pt to clinic reports went to hosp on 12NOV91 onset of pain, fever & ecchymodic lesions on lower legs; leg pain persists, fever 100.4, h/a; denies sore throat;
I had the second dose of the shingles vaccine almost a month ago and my arm is still in pain. It still feels like I've been punched very hard. I have difficulty sleeping because of the pain. I have no problem moving it but there's a constant ache. After second shot. First shot had arm pain for 3 to 5 days.
Pt had red, swollen, warm. Left arm. Size is 12x13cm pt denies pain on site. Pt was told to give 1/2 tsp Benadryl Q 6 hours and 1/2 tsp of Motrin Q 8 hours for 2-3 days. Pt will be back Monday 10/30/06 for follow up.
17JUN91 temp 99.8 (highest measured temp); had chills & fever seen by MD;
*Lightheaded *Brining up alot of mucus *Pain & swelling in right arm *Itching/slight burning under the skin- face and body *slight burning of the eyes with a little pressure * congestion  *sneezing  *partial loss of taste * tingling/burning feeling of my tongue *  headache
she had some "sharp pain" under the scapula and didn't know why.; This is a spontaneous report from a contactable consumer.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EL9262; Expiration Date: 31May2021) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6200, Expiration Date: 30Jun2021) via an unspecified route of administration on 05Mar2021 at single dose for covid-19 immunisation. The patient had rabies vaccine (She had a very bad experience 4 years ago when she got a rabies vaccine, it was given at 45°, the nurse gave the injection cutaneously, after 5 min she was so in pain.). The patient experienced some "sharp pain" under the scapula and didn't know why on an unspecified date. The outcome of the event was unknown.   No follow-up attempts are needed. No further information is expected.
The pt experienced a high fever on 12/28/00 to 1/1/01, chest tightness and hard to breathe from 12/28/00 to 12/29/00. The pt experienced weakness from 12/28/ to 1/13, hoarseness from 12/29 to 1/5 and muscle aches from 12/28 to 1/5.
Patient was given an under diluted dose of vaccine.  Patient had no issues related to the vaccine.  Attending physician was made aware.
(3-20-08) Patient noticed rash on both arms when awaking pruritic - Spread to entire body by that evening. Also developed blisters in mouth with lips swelling that evening (3-20-08). States Benadryl on 3/22/08. Began improving on 3/23/08.
has a doctor prescription for a / third dose. Patient is not immunocompromised; This case was reported by a pharmacist via call center representative and described the occurrence of intercepted drug prescribing error in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 1st june 2018) and Shingrix (received 2nd dose on 23rd august 2018).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced intercepted drug prescribing error. On an unknown date, the outcome of the intercepted drug prescribing error was unknown.  Additional Information was provided as follows: The age at vaccination was not applicable for this report. Pharmacist reported that the patient had received first and second dose of Shingrix. The pharmacist was looking for  information about a booster dose because the patient had a doctor prescription for a Shingrix third dose and till the time of reporting the patient had not received the third dose,which led to intercepted drug prescribing error. Patient was not immunocompromised. The reporter consented to follow up via email.
Almost immediately started with runny nose and cough, within 2 hours the exhaustion set in and I went to bed.  Over the next  36-48 hours I had extreme exhaustion (could barely stay awake for more than 10-15 minutes at a time), fever (100.2 at highest measurement), chills, shivering, sweats, nausea, no appetite, dizziness, very intense headache, and severe pain throughout my entire body.  Everything hurt, even my jaw, teeth, and toes hurt. I could barely  move and  definitely tried to not move due to the pain in every single muscle throughout my body.  I spent 2 full days in bed in this condition mostly sleeping and/or moaning in pain.  I did not eat for 2 days. By day 3, the fever broke and most symptoms disappeared although I continued to have an intense headache and still very tired now (day 4).
Patient was inadvertently given a third dose of moderna per his request, pt has memory loss it has been learned.
Muscle where shot was given was tender. Over the course of days, pain increased and I now have limited movement in my arm. Rotating my arm above my head or back or forward is very painful. The tendon or muscle hurts very much and pops if I go too far. I cannot take my shirt off over my head. It is difficult to drive and do other daily functions. I have a constant dull numbing pain from the site of the shot and now extends down my arm to, I believe, my middle finger. I am extremely healthy and have never experienced arm or shoulder pain before.
hives on abd, legs & arms day p/vax;next day 17SEP95 lips began to swell & went into MD office;pt was treated w/med & sent home w/med;20SEP95 2nd MD visit hives appeared worse;
Information has been received from a healthcare worker referring to 10 patients of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On unknown dates the patients were vaccinated with VAQTA (lot # L015460, expiration date 20-JUL-2017, dose, dose# and route unknown) which were improperly stored. The vaccines were stored under 48 F for 1 hour and had been back in range. The vaccines were not out of range before. No adverse event reported. This is one of several reports received from the same source. Additional information has been requested.
Patient was given vaccine that was beyond the expiration date.  However, per Pfizer manufacture, vaccine is still stable and does not need to be repeated.
SERONEGATIVE TYPE I AUTOIMMUNE PANCREATITIS; This is a literature report.  This case was the first case of suspected vaccine-induced seronegative Type I autoimmune pancreatitis (AIP) with IgG4-related disease occurring after a single dose of the Pfizer-BioNTech COVID-19 vaccine. A previously healthy 65-year-old male presented to a hospital with one week of jaundice. Two weeks prior, he had received his first dose of the COVID-19 vaccine. Admission labs demonstrated a cholestatic liver injury without eosinophilia. After initial imaging, an endoscopic ultrasound demonstrated a diffusely heterogenic pancreas with features of pancreatitis (lobularity, stranding). Endoscopic retrograde cholangiopancreatography (ERCP) demonstrated a 2cm distal common bile duct stricture. A sphincterotomy was performed and fully covered metal stent was placed (due to minor post-sphincterotomy bleeding). The patient's jaundice resolved, and he was discharged. He received his second dose of the COVID-19 vaccine shortly after hospitalization. The patient underwent the following laboratory tests and procedures: Blood bilirubin: 12 mg/dl, notes: 3 weeks post first vaccine dose; 2 mg/dl, notes: 6 weeks post first vaccine dose; 1 mg/dl, notes: 10 weeks post first vaccine dose; 4 mg/dl, notes: 12 weeks post first vaccine dose; 18 mg/dl, notes: 16 weeks post first vaccine dose (start of therapy); 12 mg/dl, notes: 18 weeks post first vaccine dose; 7 mg/dl, notes: 20 weeks post first vaccine dose; 2 mg/dl, notes: 24 weeks post first vaccine dose; 1 mg/dl, notes: 28 weeks post first vaccine dose; 1 mg/dl, notes: 34 weeks post first vaccine dose. Conclusion(s): We report a case of seronegative Type I AIP with IgG4-related disease in a previously healthy patient occurring after Pfizer-BioNTech COVID-19 vaccination. While this clinical presentation is typically associated with elevated serum IgG4 levels, our case implicates an alternate immunogenic trigger. Although such rare side effects of vaccination need to be recognized, they should not prevent physicians from recommending COVID-19 vaccination.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the event and suspect drug BNT162B2 cannot be excluded. 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.
A patient received accidently rabies in the same area, about 3 inches from where the immune globulin dose went , no AE; Initial information regarding an unsolicited valid non-serious case was received from pharmacist via Regulatory authority  (Reference number- 00638528) and transmitted to Sanofi on 12-Jun-2021.  This case involves a patient (unknown demographics) who received accidently a dose of suspect  RABIES (HDC) VACCINE [IMOVAX RABIES] (lot number and expiry date not reported) via an unknown route in an unknown administration site for unknown indication in the same area, about 3 inches from where the immune globulin dose went on an unknown date (product administration error).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included IMMUNOGLOBULIN HUMAN ANTI-RABIES (IMOGAM) for prophylactic vaccination.  The caller was reporting potential adverse event (AE) information and she said they were wondering if they need to redose the vaccine, but they were not sure what to do.   The pharmacist also wanted to know if there was any information on giving a second Imovax vaccine. Upon call back the initial caller was on another call, so this information was given to another pharmacist and the e-mail address was not asked for since there was no information to provide. The reporter gave the vaccine around the bite and then gave the rest of the shot and the vaccine in the same spot in the arm. She stated that there did not seem to be a place for what to do in that situation and all they can do is find out that it shouldn't be given in the same area.   This was a case of actual medication error due to Product administration error (latency same day).  At the time of reporting, no adverse events were 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.  There will be no information available on the batch number for this case.
Arm soreness after received the Pfizer COVID-19 Vaccines; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient received BNT162b2 (BNT162B2), on 24Nov2021 as dose 3 (booster), single (Lot number: FJ8757) at the age of 64 years for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: BNT162b2 (Dose 1, Single, received on 02Apr2021. , Lot: ER8733, Expiry/NDC: Unknown), administration date: 02Apr2021, when the patient was 63-year-old, for COVID-19 Immunization, reaction(s): "arm soreness"; BNT162b2 (Dose 2, Single, received on 30Apr2021. , Lot: EW0173, Expiry/NDC: Unknown), administration date: 30Apr2021, when the patient was 63-year-old, for COVID-19 Immunization, reaction(s): "arm soreness".  Additional information: Verifies that her arm was sore with all of her Pfizer COVID-19 doses. States that if you give her any kind of shot, her arm will hurt. Her mother had cancer, and when they did radiation on her, her skin turned green. The doctors took a bunch of pictures and put her in a medical journal. Arm soreness after received the Pfizer COVID-19 Vaccines began the night she received the vaccine and lasted about 2-3 days. No additional Vaccines Administered on Same Date of the Pfizer Suspect. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Family Medical History Relevant to Adverse Events was None. History: States that she takes vitamins.  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 24Nov2021, outcome "recovered" (Nov2021), described as "Arm soreness after received the Pfizer COVID-19 Vaccines".
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Patient medical history and current condition was not reported. On 30-JAN-2015 the patient was vaccinated with improperly stored dose of VARIVAX (Merck) (dose, dose number, route, lot/batch number, expiration date were not reported) (reported as that underwent temperature excursions). No adverse event was reported. No product quality complaint (PQC) involved. The outcome of the event was unknown. This is one of several reports from the same source. Additional information has been requested.
I had an immune response (mid-grade fever, headache, body aches, dizziness) like I have never experienced with any vaccine except the Moderna COVID vaccine dose #2. The response felt almost exactly like that of Moderna COVID vaccine dose #2. My fever started around 1am, about 12 hours post vaccine. It lasted until 42 hours post vaccine and reached a maximum of 102.1 degF. I felt significantly dizzy/disoriented and painful aches near lymph node clusters, particularly hips. Major fatigue - stayed in bed all day. The fever and pain responded to ibuprofen.
Tiredness next day and second day after, napped, slept a lot overnight; Cold Sweat second day,  lay down and napped; Somewhat Upset stomach/diarrhea;  second day and after, otc meds for diarrhea
Janssen COVID-19 Vaccine EUA  Bruising and soreness around injection site, low-grade fever (~100.25 degrees Fahrenheit), muscle aches mostly along posterior chain from shoulders/neck to legs, sleeplessness, mild headache behind eyes. Symptoms first appeared approximately 12 hours after injection. Patient self-treated with 400 mg of Ibuprofen at approximately 9:00 AM on 7/8/21, roughly 19 hours after injection. Symptoms were minimized.