chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the patient right deltoid became very swollen, with a red round area about 2 and a half inches, it is warm to touch, not necessarily painful but she running a low grade fever at 99.4 F; the patient right deltoid became very swollen, with a red round area about 2 and a half inches, it is warm to touch, not necessarily painful but she running a low grade fever at 99.4 F; the patient right deltoid became very swollen, with a red round area about 2 and a half inches, it is warm to touch, not necessarily painful but she running a low grade fever at 99.4 F; the patient right deltoid became very swollen, with a red round area about 2 and a half inches, it is warm to touch, not necessarily painful but she running a low grade fever at 99.4 F; the patient right deltoid became very swollen, with a red round area about 2 and a half inches, it is warm to touch, not necessarily painful but she running a low grade fever at 99.4 F; Initial information regarding an unsolicited valid non-serious case received from a nurse and transmitted to Sanofi on 15-Oct-2020.  This case involved a 80 years old female patient right deltoid became very swollen, with a red round area about 2 and a half inches, it is warm to touch, not necessarily painful (vaccination site inflammation associated with vaccination site erythema and vaccination site swelling and vaccination site warmth) but she running a low grade fever at 99.4 F (pyrexia), while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  Relevant medical history, past medical treatment, vaccination and family history were not provided.  At the time of the event, the patient had ongoing COVID-19.  Concomitant medications included INFLUENZA VACCINE INACT SPLIT 3V (FLUZONE HIGH DOSE) and PARACETAMOL (TYLENOL).  On 08-Oct-2020, the patient received a 0.5 mL dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot U6706AA, expiry date: 30-Jul-2022) via intramuscular route in the right deltoid for prophylactic vaccination.  On an unknown date, deltoid became very swollen, with a red round area about 2 and a half inches, it is warm to touch, not necessarily painful (vaccination site inflammation associated with vaccination site erythema and vaccination site swelling and vaccination site warmth) but she running a low grade fever at 99.4 F (pyrexia), 3 days (as reported) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Final diagnosis was the patient right deltoid became very swollen, with a red round area about 2 and a half inches, it is warm to touch, not necessarily painful but she running a low grade fever at 99.4 f and the patient right deltoid became very swollen, with a red round area about 2 and a half inches, it is warm to touch, not necessarily painful but she running a low grade fever at 99.4 f.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported events.
Five days post vax, this pt experienced fever, irritability, and decreased appetite. Medical attention was sought. A nurse practitioner reported that this event was not a vax reaction. The child had strep pharyngitis and the had a question only.
Patient describes tingling down her right arm where tha vaccine was administered and some numbness and tingling in her index finger.
Vomiting evening of shot, diarrhea for two days after shot, aching, chills, fatigue  for two and a half days following the shot
This spontaneous report as received from a registered nurse via Sanofi Pasteur refers to a 39 years old male patient with no known allergies and none illness at time of vaccination. The patient's medical history included coarctation of aortal repair in 1977. The patient was vaccinated with the third dose of PNEUMOVAX 23 (lot # 672962/0025AE) intramuscularly on his left deltoid at 04-SEP-2012 11:00 am. No other co-suspects were reported. There were no concomitant medications. At 05-SEP-2012 6:00 am the patient noticed area of redness measuring 8cm x 3cm and area warm to touch with skin intact, afebrile. It was unspecified if the patient had sought medical attention. There were no relevant diagnostics tests or laboratory data. The outcome of area of redness and area warm to touch was unknown at time of this report. Additional information is not expected.
Patient was given vaccine in left deltoid. Approximately 10-15 minutes later, father came to the window to report patient's throat feels tight and closing and patient is getting flushed. I verified with patient if she can breathe, and she stated she could only breathe through her nose, and her throat is tight and closing. I went out of the pharmacy and administered the EpiPen dose on outer left thigh as the other pharmacist was calling 911. The mother arrived at the pharmacy and stated to us she is an ER nurse and told us to cancel the 911 response as she would take the patient to ER immediately. Patient was given the vaccination card and mother took patient away to go to ER, as patient could still walk. The patient appeared stable.
He still has some ringing in the ear and heaviness around the head; He still has some ringing in the ear and heaviness around the head; If he hears the slightest noise it is louder than normal; This is a spontaneous report from a contactable consumer (reporting for himself) via the medical information team. A male patient of an unspecified age received his second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Jan2021 (reported as a month ago) to Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient stated that he still has some ringing in the ear and heaviness around the head. He consulted his doctor and his conclusion after the assessment was that it did not seem to be related to vertigo. The patient stated that if he hears the slightest noise it was louder than normal. The outcome of the event tinnitus and head discomfort was not recovered while unknown for the other event.  Information on the Batch/Lot number has been requested.
After the shot pain in arm at night tired and heaviness almost like jet lag. All I want to do is sleep for the next couple of days. Pain in arm for first week but went away, then it came back. Since it has been on and off pain even up to today. Also, had unusual aches at the joints where had injury 2years before the vaccine. PT finish recently and still has increased pain on bad days.
vaccine didn't help, still got shingles/suspected vaccination failure; shingles, under breast; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 18-Aug-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient stated that the so called vaccine did not helped him/her. The patient still got shingles under his/her breast. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Initial information received on 04-Dec-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves patient of an unknown age who received first dose of vaccine IMOVAX RABIES (Powder and solvent for suspension for injection) lot N1B05, expiry date: 26-Feb-2017 via unknown route in unknown administration site on an unknown date. Patient also received two doses from the series of three RABIES shots given by health care provider. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to expired vaccine used. He/she noticed that the first injection in the series of three was LOT NO: N1B05 (he/she not sure if that is a zero or the letter 'o') The expiration date on that was marked as 02/26/2017 - WELL OVER a year and a half EXPIRED. It was unknown if any adverse event was occurred. 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 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. Documents held by sender: none.
Chills and uncontrollable Shaking at 2 am approximately 15 hrs after the vaccine and nausea with vomiting at 4 am approximately 17 hrs after the vaccine
Very sick for three days as reported through CDC checking site. On 4/18 I began feeling extremely nauseous and had diarrhea and then began vomiting blood for over twelve hours.  I went to the ER on 4/19 where they did an MRI and found two hemmorhaging lesions on the right side of my brain.
Facial and truncal rash unrelieved by 50 mg diphenhydramine. No cough. No ocular symptoms. No malaise now. 3 days ago she felt weak and slept a lot -- felt as though she might be getting sick, but then felt improved the next day.
per patient's daughter: COVID vaccine was given on October 2020. Patient received 2 doses total.  He was admitted in the hospital 10 days ago due to COVID and pneumonia.
severe psoriasis; Large and small red welts and bumps; Large and small red welts and bumps; It is incredibly itchy; This is a spontaneous report received from a contactable consumer (patient). This 61-year-old male 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 24Mar2021 at 18:15 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included ulcerative colitis, and penicillin early generation allergy, both from unknown dates and unknown if ongoing. Prior to vaccination the patient was not diagnosed with COVID-19. The patient had no allergies to foods. Concomitant medications included prednisone 5 mg from an unknown date for an unknown indication. Prior to vaccination the patient received azathioprine from an unknown date for an unknown indication and experienced drug allergy; infliximab (REMICADE) from an unknown date for an unknown indication and experienced psoriasis; adalimumab (HUMIRA) from an unknown date for an unknown indication and experienced psoriasis; and received the first dose of BNT162B2 (lot number unknown) on 24Feb2021 at 18:15 (at the age of 60-years-old) for COVID-19 immunisation. The patient had not received any other vaccines in the four weeks prior to the COVID vaccine. The patient reported that on 04Apr2021 he developed severe psoriasis within three weeks of the vaccine; further stating he developed similar reactions to infliximab and adalimumab and generally had received methotrexate to control the reaction. He reported large and small red welts and bumps on his arms, torso and hands, as well as to a lesser extent his face, scalp, buttocks, legs and feet. He reported it was incredibly itchy, similar to poison ivy or bad psoriasis. He reported not having these symptoms prior to the vaccine, that there had been no intervening medicines, and that he had no food allergies. The clinical outcomes of severe psoriasis, large and small red welts and bumps, and it was incredibly itchy were not recovered. It was also reported that since vaccination the patient had not been tested for COVID-19.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient reports hx of back pain. States an episode began on 4/4/2021. His usual back pain episodes last 3 days, maximum. This round of back pain has continued. Patient reports only variance was receiving the Janssen COVID vaccine on 4/7/2021. Patient contacted his PCP for evaluation and is unable to be evaluated until July.
Chills all nite, then rash on arm 1st nite. Shot area chills, whole day in bed next day. Muscle left red - surface redness, now gone.
Pt has redness, swelling, hot to touch, approx 8 inches below the site wrapping around the site of injection per Medical staff at Clinic.
From the injection site to her fingers, she feels tingling; Thumb and index fingers were numb; Tingling; Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm), HYPOAESTHESIA (Thumb and index fingers were numb), PARAESTHESIA (Tingling) and VACCINATION SITE PARAESTHESIA (From the injection site to her fingers, she feels tingling) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B2(Z)1A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and High cholesterol. Concomitant products included LOSARTAN, ATORVASTATIN and FENOFIBRATE for an unknown indication.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm). On 06-Apr-2021, the patient experienced HYPOAESTHESIA (Thumb and index fingers were numb) and PARAESTHESIA (Tingling). On 25-Apr-2021, the patient experienced VACCINATION SITE PARAESTHESIA (From the injection site to her fingers, she feels tingling). At the time of the report, PAIN IN EXTREMITY (Pain in arm), HYPOAESTHESIA (Thumb and index fingers were numb), PARAESTHESIA (Tingling) and VACCINATION SITE PARAESTHESIA (From the injection site to her fingers, she feels tingling) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: TCR received  No new information reported. reporter hung up the phone.
administered only the diluent portion; administered only the diluent portion; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.       Additional Information: GSK receipt date: 01-AUG-2022 Reporter's comment: The Nurse reported that an unknown patient was administered only the diluent portion of the Menveo. They had discovered this after going to the clinic where they found one vial of the lyophilized vaccine. The reporter gave consent to follow up. Additional supportive information: The patient was administered only the only the diluent portion of the Menveo which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Having numbness in right arm and face and neck on right side; And some vision issues; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0158) via an unspecified route of administration in the right arm on 15Apr2021 at 16:30 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism (reported as Low thyroid). Concomitant medications taken within trwo weeks of vaccination included gemfibrozil (LOPID) (reported as Synthetic lopid), omeprazole (PRILOSEC), tramadol (MANUFACTURER UNKNOWN), naproxen sodium (ALEVE) and calcium vi; all from unknown date for unknown indication. The patient previously took metronidazole (FLAGYL) and experienced drug allergy. The patient previously took fentanyl (MANUFACTURER UNKNOWN) 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. The patient was having numbness in right arm and face and neck on right side. Started two days after vaccine on 17Apr2021. And some vision issues. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events having numbness in right arm and face and neck on right side, some vision issues was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Apr-2021 at 3:54 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 29-Apr-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 33.53.  Concomitant products were not provided. On 29-Apr-2021, Excursion time was 10 AM temperature was 33 total doses given for the day was 201, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 19-Apr-2021, vial was moved to clinic on 29-Apr-2021. 5 vials were sent to clinic. Vaccine BUD date was 19-May-2021.  On 29-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 36, 10 AM: 33, 11 AM: 44, 12 AM: 45, 1PM: 45, 2 PM: 44, 3 PM: 45, 4 PM: 44.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Patient began experiencing fuzzy tongue and itchiness all over within 15 minutes of receiving vaccination. Patient was provided 50mg Benadryl and observed for 15-20 minutes at which point they began improving. Patient was checked in on after about an hour and was doing okay.
papular rash on left forearm 2 days after administered. similar rash on right forearm a few days later, then similar rash on lower back one week later. Rash not vesicular, not painful. Intermittently itchy.
20 mins p/shot pt had swelling 1st knuckle w/itching; broke out s/rash on face w/1 hr p/shot; w/15 mins of shot had knot on ball of rt foot w/swelling up to rt knee w/itching;
First dose: Had headaches after receiving the first dose Pfizer Covid Vaccine and they literally only lasted a day; This is a spontaneous report from a contactable consumer or other non-health professional (patient). A 37-years-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; Batch/Lot Number: EW0158, expiration date not reported) via an unspecified route of administration, administered in Arm Left on 23Apr2021 (age at vaccination 37-year-old) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient had no medical history and no concomitant medications. Patient did not have COVID or anything like that. Family history was reported as one of the patient sisters had Covid. The patient stated she had to receive the Pfizer Covid Vaccine because the patient was on the list, because of genetics and testing positive for stomach cancer in genetic testing. Patient stated its weird, a lot of cancer going on right now. On 25Apr2021 patient had headaches after receiving the first dose Pfizer Covid Vaccine and they literally only lasted a day. The patient stated she received the first dose Pfizer Covid Vaccine on Friday, 23APR2021 and the headaches began that Sunday, 25Apr2021. Reportedly, patient took second dose of Pfizer Covid Vaccine on 14May2021. There were no prior vaccination within 4 weeks of vaccination. The patient recovered from the headache, just made sure to stay hydrated and took Ibuprofen. There was no investigation assessment or relevant tests. The outcome of the event was recovered on 26Apr2021.  Follow up needed, further information has been requested.
Narrative:  79 year old male admitted on July 19 2022 with low grade fever and hypoxia. He had received Moderna vaccine x 4 on December 28 2020, January 25 2021, October 29 2021, June 7 2022. He was treated with remdesivir 200 mg x 1 then 100 mg IV daily x 4 days and dexamethasone 6 mg daily x 9 days. Patient clinically improved and was transferred back to long term care isolation on 7/28. Patient passed away on the evening of 7/28 with immediate cause of death as dysphagia complicated by aspiration pneumonia and COVID-19. Appears that patient started cough after taking a sip of water and went into cardiopulmonary arrest.