chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm muscle soreness; Some chills; Muscle tension; This is a spontaneous report from a non-contactable consumer, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 11Apr2021(at the age of 42-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy and crustaceans/shellfish allergy. Concomitant medications included Multi-vitamins (MANUFACTURER UNKNOWN, ascorbic acid (VIT C), colecalciferol (VIT D3), fish oil (MANUFACTURER UNKNOWN), ascorbic acid, vaccinium spp. (CRANBERRY) and mexiletine hydrochloride (MELATE); all for unknown indication from an unknown date. 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 11Apr2021, the patient experienced arm muscle soreness, some chills and muscle tension. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events arm muscle soreness, some chills and muscle tension were unknown at the time of this report.  No follow up attempts are needed. No further information is expected.
Patient got his 2nd covid vaccine on 3/19 and has not been right since. wife reported a few days later to the pcp that his blood sugars are low and wife states he is suddenly having a hard time putting his thoughts together. Wife also says he his having a harder time breathing. was sent for blood work and chest x ray by pcp and placed on steroids. wife called back on 3/25 to pcp reporting no improvement in his breathing or condition.   He was admitted to hospital on 3/31 for b/l pneumonia and UTI. treated with antibiotics. Hospitalization complicated by delirium.  discharged home on 4/3. readmitted on 4/26 with acute/idiopathic pancreatitis. work up reveals no cause for the pancreatitis and is being reported as a possible immune mediated adverse side effect from his vaccination. He remains hospitalized in the ICU as of 4/28
Initial and follow up information has been received from a wholesaler's representative and a certified medical assistant concerning a 65 year old German female certified nursing assistant.  On 05-OCT-2006, at 10:00 AM, the patient was vaccinated intramuscularly in the deltoid with the second dose of PNEUMOVAX (Lot# 651404/0352F).  There were no illnesses noted at the time of vaccination.  On 06-OCT-2006, at 7:00 AM, the patient developed mottled erythema, tenderness and swelling distal to the injection site by a few centimeters and circumferential (previously reported as soreness, infection at the injection site, symptoms that consisted of severe subcutaneous edema which appeared down past the elbow near the forearm and edema accompanied by severe pain).  There was no reaction at the injection site.  At the time of this report, the patient had recovered from the events (date unknown).  No further information is available.
By 9:50, at injection site:  pain, swelling. By 12:00 PM:  location 4-5 inches surrounding injection site:  increased pain, increased swelling, itching, muscle harder/firmer, redness.  Above symptoms continue throughout the first and second day with following additional symptoms: patient tired, sleepy, crying, chilled, decreased appetite.
This was a cluster of eight patients who experienced adverse events after administration of intradermal FLUZONE (lot number not reported) instead of a TB test. One patient had been identified and was captured in case number 2012-03923. Initial report was received from a health care professional on 12 April 2012 which also involved a case of misuse (wrong route of administration and wrong drug administered). Seven patients (genders, ages and date of birth not reported) had received a 0.5ml intradermal injection of FLUZONE (lot number not reported) instead of a TB test in March of 2012. In March of 2012, the patients experienced immediate burning and itching, cellulitis at some degree, pain from the axillary area down arm to hands, numbness and tingling into arms and hands which is intermittent and a lump at the injection site. The patients had no illness at the time of vaccination. Concomitant medications and past medical history were not reported. Of the eight total patients, three patients were still having symptoms and five patients symptoms had resolved. Documents held by sender: None.
(R) arm and axillary lymph node swelling approximately 48 hours after received Td in the hospital ER for tetanus prophylaxis after hand laceration. Diagnosis of cellulitis. Patient treated with antibiotics, improved and discharged.
08/25/22 presents to ED for "COVID". PMHx of "dementia, aortic valve replacement on coumadin, spinal stenosis with recent rhizotomy"
vaccine administration error. tdap given in error instead of dtap. no adverse reaction noted in patient at time of this report. mother notified of error.
This spontaneous report was received from a registered nurse refers to unknown number of patients of unknown demographics. No relevant medical history of the patients was reported. On an unknown date the patients were vaccinated with ROTATEQ (strength, dose, lot number and expiration dates were not reported) orally. No concomitant medications were reported. It was reported that since 18-AUG-2014, unknown number of patients were administered with ROTATEQ which was improperly stored. This was supported. No adverse effects were reported. There was no product quality complaint involved. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Developed facial urticaria, swelling, and shortness of breath shortly after H1N1 vacc today. Received IV BENADRYL, SOLUMEDROL, ZANTAC, & ZOFRAN in ER with resolution of symptoms.
My shot was given in my left arm and the right side of my face became flush and slightly swelled - treated with benadryl
Itchy, hot, red area on arm about  2.5 in wide, 6 in long
Arm pain where I got the shot, we both have the symptoms; Arm pain where I got the shot, we both have the symptoms; I have diarrhea; Stomach pains; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 64 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1:, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2:, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "Arm pain where I got the shot, we both have the symptoms"; DIARRHOEA (non-serious), outcome "unknown", described as "I have diarrhea"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "Stomach pains".  Additional information: Reporter stated that he got booster shot and already had the first two doses. He had diarrhea, stomach pains, and arm pain where he got the shot. Reporter stated that he already had reported side effects in front of him from the paper they gave him  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Did get a sore arm with her 1st dose; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EW0158) via an unspecified route of administration in left arm on 07Apr2021 at 14:00 (at the age of 44-year-old) as single dose for COVID-19 immunization. Medical history of the patient was not reported. Concomitant medication included multivitamins [besides a multivitamin patient does not take anything on a regular basis and sees the HCP once a year; states she does not get sick often and was pretty healthy, eats well, takes vitamins and has an occasional glass of wine]. Patient previously received flu vaccine for immunization and has soreness in her arm. On an unspecified date in 2021, the patient experienced a sore arm with her 1st dose, the arm soreness was for a couple of days or so and was gone. It was reported that she has no name of the flu vaccine she had a sore arm with and no lot number, expiry date or NDC to provide and states the flu shot tends to cause soreness the same day and then she is fine and the Pfizer COVID19 1st dose she was sore a couple of days but it did not prohibit her from doing anything and was just noticeable. AE's does not require a visit to: Emergency Room, Physician Office. No Prior Vaccinations (within 4 weeks) administered. Outcome of the event was resolved on an unspecified date in 2021.  Additional information has been requested.
3/13/2021 Moderna 027A21A 2/13/2021 Moderna 031L20A  8/29/2023 - 8/31/2023 (2 days) Date of Admission: 8/29/2023  Discharge Date: 8/31/2023 Discharge Disposition: Home or Self Care COVID infection No signs or symptoms suggestive of upper or lower respiratory tract infection Afebrile, hemodynamically stable and maintaining saturation room air CXR with no focal infiltrates Monitor vital signs and symptoms trend  past medical history of hypertension, hyperlipidemia, overweight, history of COVID.  Admitted as a case of biliary pancreatitis.
Attending Physician: DO     Date of Admission: 1/21/2022   Chief Complaint Patient presents with ? Shortness of Breath     COVID+ as of 1/18. arrived via EMS on NRB, described exertional dyspnea on scene. A&O x4 upon arrival.     Source of Information:  Patient and Available medical record   History of Present Illness:  This is a 69y.o. male with pmh of  Renal transplant  ckd since transplant  Cad,s/p cabg x 2 Cardiomyopath,ischemic and non ischemic  paf  Pad  Brought in by EMS after he was recently tested positive for covid on 1/18 and for sob,since tested positive for covid,wife states patient has poor appetite,has sob,and not taking his medication.evaluatedd in ed and admitted. Patient is vaccinated for covid,per medical record Work up in ed shows  V tach for more than 18 beats,for which cardiology recommend to resume his home medication of coreg Chest xray -- patchy bilateral air space disease c/w infectious etiology Wbc 5.7 Troponin 0.14,0.14 When seen in ed patient awake and alert,but not able to tell the reason for coming to the ed and at this time denies any complaints and using o2 per nasal canula,looks slightly sob.
12 hrs at 66.92 °F and  42 hrs 24 minutes at 65.6 °F; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received Men B NVS (Bexsero) (batch number 59M3M, expiry date 28th February 2023) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th November 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 30-NOV-2022 Reporter's Comment: The reporter reported that the Bexsero vaccine had a temperature excursion lasting 12 hours with maximum temperature of 66.92 Fahrenheit, and then a second excursion lasting 42 hours 24 minutes, with a maximum temperature of 65.6 Fahrenheit. The reporter reported that the vaccine was administered to the patient after the second excursion occurred. At the time of reporting, the reporter did not had patient specific identifiers. The vaccine administration facility was the same as primary reporter. The reporter did consent to follow up. Additional supportive information: The Bexsero vaccine temperature was exposed upto 66.92 Fahrenheit for 12 hours and 65.6 Fahrenheit for 42 hours and 24 minutes which led to incorrect storage of drug. This case was 1 of 3 cases for the patient reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR179995:same reporter US-GSK-US2022179395:same reporter
Swelling at injection site, Hot. Site was Iced; patient was treated with 1GM of Rocephin IM.
VOMITING; LIGHT HEADEDNESS; WEAKNESS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced vomiting, light headedness, and weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vomiting, light headedness and weakness was not reported. This report was non-serious.
Death Narrative:  Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug  event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was 93 and receiving home based palliative care. On 3/30/21 his home nurse reported he was having bilateral lung wheezing. On 4/16/21 patient's wife stated he passed away at home after suffering an "asthma attack." PMH significant for dementia, malnutrition, reduced mobility, bedbound, Alzheimer's, DM, afib, CAD, NSTEMI
PATIENT EXPERIENCED RAISED BUMP AT INJECTION SITE IMMEDIATELY. AFTER AN HOUR SHE HAD RED BLOTCHES DOWN BOTH ARMS, TINGLING TONGUE, AND TIGHT/SCRATCHY THROAT
Day p/shot did not sleep all night, wouldn't eat or drink, small red spots on face, runny nose, t99.4, much phlegm in throat; To MD lt thigh has 1/2" reddened bump was painful;
Five hours after receiving the vaccination my arm was very sore at the injection site. Then immediately the pain went from my shoulder, to my elbow, to my wrist, ending in tingling in my finger tips. I got one shot on 11-24-2021 (Moderna). Today I am writing this on 12-18-2021 and my arm feels the exact way. I went to the E.R. on 12-9-2021 and the doctor gave me medicine for inflammation and pain. It was not working so  I then went to the doctor on 12-16-2021 and he said the medicine prescribed to me is no use because the shot I received re-activated my tendonitis that I had from playing high school sports. Dr.  wrote me a note stating and proving this is a fact. I brought to the doctors attention that I once had COVID in December of 2020, he then tested my anti body level by drawing my blood.
Unknown number of patients have received improperly stored doses of VARIVAX.; no reported adverse events; This spontaneous report as received from a Medical Assistant referring to an unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On unknown dates, the patients were vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (Strength, route, dose, frequency, and anatomical location were unknown) with lot # R017642 and expiration date 20-JUN-2020. The administered doses of the vaccine experienced the temperature excursion of 25.5 F  degrees Fahrenheit  for 1hour and 30 minutes. There was a digital data logger invloved, but there was no previous temperature excursion.  Follow-up information was received from the medical assistant on 09-APR-2019, regarding a female patient who is reported to be under 10 years of age. There were no reported adverse events following the administration of varicella virus vaccine live (oka/merck)(VARIVAX) (No adverse event).  This is one of two reports received from the same reporter.
Exact flu shot given unknown.  Reactions - low fever, body aches, headache, nausea.  Lasted about 24 hours.  Took Aleve, slight improvement.
2 cm subcutaneous nodule lasting approximately 1+ weeks with accompanying patch of swelling/redness lasting less than 1 week in left arm at injection site.
2 days after vaccine 4 1/2 inch by 4 1/4 inch raised reddened area. Pt given 1 tsp Attarax and cold compress.
Soreness began in left arm, immediately after injection & continued into the evening. Took Aleve & went to bed. It seemed to improve, however, on 11/15 or 11/16, it re-occurred with pain on lifting arm. On 11/18, neck stiffness developed.
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date the patients were vaccinated with improperly stored ZOSTAVAX, lot# L046295 with expiry date: 17-FEB-2017 (dosing details, expiry date were not reported). It was reported that the vaccines were exposed to the temperature of 24.3 F during a time frame of 8 hours and 30 minutes. No previous temperature excursion was reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Client called at 14:45 c/o heart racing and mild shortness of breath 30 min after receiving vaccine. These sx subsided and was c/o of fatigue, body aches and head cold/congestion sx.
Irritability started around 11:30 PM.  Slept fitfully off and on for 15 minutes at a time for the rest of the night.  Developed low grade fever around 2:00 AM that continued through the 26th.  He was then weak, unsteady on his feet, and just wanted to lay on mom all morning.  Last substantial PO intake was at bedtime on the 24th. Did not resolve until the 26th at bedtime.
0700- Vaccine  0800 -2200- Clear urine, 1-2 times per hour, 300-500ml each time  2200-2300 sleep 2300 - woke up, felt jittery, provided car for emergent surgical case 0100 - felt like headed,  drank 50oz water, felt better after 20 minutes  0400 - 0700 - sleep. Woke up 3 -5 times and urinated 300-500 each time clear urine  0800- 0900 - drove home 0900-1000- Urinated 3 times while attempting to fall asleep, each time 500ml if clear urine. Massive 10/10 right sided headache  1000-1300 sleep 1300- present- woke up. Felt ok, able to eat and drink, felt ?normal? by the following morning
A non-serious spontaneous report of "FLUMIST got in her eye" was received from a registered nurse concerning a three-year-old female. Medical history and concomitant medications were not reported. On 06-Nov-2008, during administration of FLUMIST, the patient moved and experienced exposure of the vaccine into her eyes. The reporter inquired about what to expect from this exposure. The reporter states that the medication error occurred at another clinic and no additional information is available, however, the nurse did submit a VARES report for this case. There was no adverse event associated with this medication error; therefore, treatment and reporter / sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.
Localized swelling w/redness rt arm w/in 5-10min; MD informed & ordered DPH & condition improved;
This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back is hurting), MICTURITION URGENCY (go to bathroom a lot after every 5 minutes), CHILLS (chills), MYALGIA (body ache) and CHILLS (shivering) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced BACK PAIN (back is hurting), MICTURITION URGENCY (go to bathroom a lot after every 5 minutes), CHILLS (chills), MYALGIA (body ache) and CHILLS (shivering). At the time of the report, BACK PAIN (back is hurting), MICTURITION URGENCY (go to bathroom a lot after every 5 minutes), CHILLS (chills), MYALGIA (body ache) and CHILLS (shivering) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, Body temperature: 101 f (High) increased body temperature. On 17-Mar-2021, Body temperature: 105 f (High) increased body temperature.         Patient is on  Blood pressure medication. The patient is on blood pressure medication. No treatment information was provided.
Acute hypoxic respiratory failure secondary to COVID pneumonia in a 71-year-old male with unknown past medical history transferred from outside hospital intubated and sedated on ketamine and propofol.  Versed drip stopped on arrival to our ICU.
Sore arm, burning feeling on entire arm like a sunburn. Lightheaded and fatigued.
Slight redness appeared on left arm 4 days after 2nd shot - June 25th. July 4th face swelled around eyes only. Went to ER on July 5th. Steroids were recommended but I opted out. Swelling was gone by July 15th. Rashes continued to spread & get worse covering both arms, upper thighs, torso & forehead. Left arm slightly swelled mid July but did not seek treatment; went away after about 2 weeks. Right arm swelled & left leg swelled on Aug 13th. Went to Urgent Care & was prescribed steroids - 20 mg once a day for 7 days. Arm swelling went down after the 7 days (Aug 20th) but leg swelling continued until Aug 24th. Rashes continued to spread to my lower back, down to my knees, back of my thighs, up from my torso across my chest. Right arm swelled again Aug 29th & legs & thighs swell again on Aug 30th. Rashes still continuing to itch & burn over 90% of body.
This spontaneous report as received from a nurse and a healthcare worker refers to a 4 year old female patient. The patient's concurrent conditions, medical history and concomitant therapy were not provided. On 07-DEC-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) recombinant human albumin (rHA), lot # L030586 with an expiration date on 10-FEB-2017 (dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.