chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Symptomatic for COVID/Tested positive for COVID; Allergy; This spontaneous case was received on 26-Oct-2022 from Pfizer Inc. with additional information received on the same date (being process together) via Communications and concerned a 46-years-old, male patient.  The patient's concurrent condition included unspecified allergy. The patient's concomitant medications included: rosuvastatin, Fibercon (polycarbophil calcium) and escitalopram. The patient historical vaccines included three dosages of Moderna COVID-19 vaccine (elasomeran), received on 13-Jan-2021 (batch number: 012L20A), 11-Feb-2021 (batch number: 030620A) and 02-Nov-2021 (batch number: 032F21A), for unreported indication and with no adverse events reported.  On 22-Sep-2022, the patient was vaccinated with Flucelvax Quadrivalent (dose: 0.5 ml; anatomical location: right arm, route of administration: not reported) for prevention of influenza disease. The batch number was not reported.  On the same date, the patient was vaccinated with non-company, co-suspect Pfizer-BioNTech COVID-19 Vaccine, Bivalent (tozinameran, riltozinameran; dose: reported as 'four', anatomical location: left arm, route of administration and indication: not reported). The batch number reported was 6H9694.  On unspecified date in 2022, an unknown amount of time after receiving Flucelvax Quadrivalent and non-company, co-suspect Pfizer BioNTech COVID-19 vaccine, Bivalent, the patient experienced allergy.  On 01-Oct-2022, nine days after receiving Flucelvax Quadrivalent and non-company, co-suspect Pfizer BioNTech COVID-19 vaccine, Bivalent, the patient started to be symptomatic for COVID.   On 03-Oct-2022, the Nasal Swab (Binax) COVID-19 test was positive.  On 05-Oct-2022, the patient was tested for COVID-19, however, results were not provided.  At the time of initial reporting on 26-Oct-2022, the patient was recovering from the event COVID-19.  The outcome of the event allergy was unknown.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A 46-year-old patient was vaccinated with Flucelvax Quadrivalent and non-company, co-suspect Pfizer-BioNTech COVID-19 Vaccine. Nine days later, the patient started to be symptomatic for COVID. An unknown amount of time after vaccination, the patient experienced allergy. Considering unclear chronology, causality is unassessable for the event of allergy. Based on biological implausibility, COVID-19 is assessed as not related to the suspect vaccine.; Sender's Comments: A 46-year-old patient was vaccinated with Flucelvax Quadrivalent and non-company, co-suspect Pfizer-BioNTech COVID-19 Vaccine. Nine days later, the patient started to be symptomatic for COVID. An unknown amount of time after vaccination, the patient experienced allergy. Considering unclear chronology, causality is unassessable for the event of allergy. Based on biological implausibility, COVID-19 is assessed as not related to the suspect vaccine.
Expired vaccine was given. Patient will be contacted to repeat dose, per CDC recommendations. Patient's 4th dose. No problems noted.
broke her leg; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer or other non hcp (Patient).  A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 13Apr2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. She was not sure of the date for her second dose appointment (either 03May2021 or 04May2021). On 27Apr2021 or 28Apr2021, she was broke her leg and received 5 mg of Hydrocodone (Vicodin) to relieve pain. Her doctor mentioned she might be needing to undergo surgery. She called to verify the date and time for her second dose appointment. Therapeutic measures were taken as a result of broke her leg. The outcome for the event was unknown.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Fever 100.2 Fahrenheit; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever 100.2 Fahrenheit) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced PYREXIA (Fever 100.2 Fahrenheit). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever 100.2 Fahrenheit) outcome was unknown.            No relevant concomitant medications were reported.     This case was linked to MOD-2021-044128 (Patient Link).
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021 at 1:37 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 1:37 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 69.10 for dose administered on 20-Mar-2021. No concomitant medications were reported. Batch number 031A21A underwent temperature excursion on 20-Mar-2021 with temperature 34 degrees Fahrenheit at 09:00 AM and 37 degrees Fahrenheit at 10:00 AM. This vial was moved to fridge on 09-Mar-2021 and beyond use date for the vial was reported as 08-Apr-2021. Product moved to clinic on 20-Mar-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour. No treatment medications were reported.
Shingles; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (Shingles) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced HERPES ZOSTER (Shingles). The patient was treated with ACYCLOVIR [ACICLOVIR] for Shingles, at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (Shingles) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.    Reporter did not allow further contact
Feeling nausea, weak, dizzy.  Had a brain banana since yesterday.  HR 60 reg.  BP 106/81, O2 Sat 100%.
pt devel edema of the inject arm from the shoulder to elbow p/receiving Typhoid vax;
Information has been received from a consumer concerning a 12 month old female pt with no medical history who on approximately 05/11/03 was vaccinated SC with a 0.5mL dose of MMRII. Concomitant therapy on approximately 05/11/03 included a dose of Varicella virus vaccine live. Ten days later, on approximately 05/21/03 the pt developed a rash (# of lesions not known) all over the body. Subsequently, the pt recovered on her own in one week. It was noted that the pt's twin brother had the same experience (WAES # 0308USA01318).  Additional information has been requested.
8/15/12 Phone call from mother, child has blotchy rash on legs, arms and face. Acting normal. Referred to doctor for evaluation. Mom to take her and call with results.
Information has been received from a registered pharmacist (R.Ph.) concerning a 15-month-old male with no pertinent medical history or allergies, who on 11-JAN-2007 was vaccinated with a dose of MMR II. Concomitant therapy included vitamins with fluoride. On 17-JAN-2007 the patient experienced fever of 101 degrees Fahrenheit. He was treated with TYLENOL. The child also had a fever of 103 degrees Fahrenheit that started on the evening of 18-JAN-2007 and lasted through the night until about 3 am. The fever at one point had reached 104 degrees Fahrenheit. He was treated with TYLENOL. The child had another fever of 101 degrees Fahrenheit that occurred in the late afternoon of 19-JAN-2007 and he was given TYLENOL again. The child was fever free since 20-JAN-2007. On 22-JAN-2007 the child developed a rash that was barely noticeable on the head and torso. The physician's office instructed to give the child BENADRYL as needed. Unspecified medical attention was sought but no laboratory or diagnostic tests were performed. At the time of this report, the patient had not recovered. No product quality complaints were involved. Additional information has been requested.
mixed ACT-HIB with the wrong diluent on the patients 4th dose with no reported adverse event; Initial information received on 06-Apr-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 18 months old male patient who received HIB (PRP/T) VACCINE [ACT-HIB] mixed with the wrong diluent with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for Immunisation.  On 04-Apr-2023, the patient received 0.5 mL dose 4 of suspect HIB (PRP/T) VACCINE (lot UJ787AAA, strength - standard, frequency - once, expiry date - 11 Aug-2023) via intramuscular route in the left thigh for prophylactic vaccination (immunization).  On 04-Apr-2023 the patient received act-hib mixed with the wrong diluent with no reported adverse event (product preparation error) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   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.
Patient seated in observation area after vaccination at 1412. At 1422 patient reported feeling heaviness in chest rated at 7/10 pain scale, mandibular pain,  appeared diaphoretic and fatigued, skin grey/pale, though remained alert and responsive to questions appropriately. Patient also communicates she was having some chest pain prior to the immunization today, though she indicated on her forms that she was feeling well today. Vital signs assessed, P72 R16 O2 99, patient denied difficulty breathing. Rapid response protocol initiated, applied 2L O2 via NC, transferred patient to wheelchair and taken to ED for evaluation by response team. ED assessment reveals calf tenderness and patient reporting TKA x 2 weeks ago, elevated D-Dimer, CT results pending at this time.
Per patient report via MY CHART (email): "Whole upper arm from shoulder to mid upper arm; significant swelling observable to the eye, red, hot, painful for three full days. Could not on that arm for three nights. After the second day, the very red parts of the reaction began to itch. Felt no appetite and lethargic for first two days. => I will not be taking any further pneumonia vaccinations. Had a similar but less allergic response to the flu vaccine in the past => I will not be taking any further flu shots.
I came down with my first ever case of shingles 72 hours post Moderna booster. Otherwise normal side effects: swollen lymph node under arm pit, malaise, fatigue, headache.
Patient approached this RN stating that she felt lightheaded and nausous. Assisted patient to floor, lying flat with feet elevated. Pt began complaining of "dark vision," swelling sensation and tingling in tongue, numbness and tingling in bilateral upper extremities and heart racing.  Alerted physician. EMS notified for transport. Vitals obtained 1212- BP 90/48; HR 139; o2 98%; RR 22. Epipen 0.3mg LOT 0FM400 EXP 12/31/21 administered to R thigh at 1215 per physician order. 20g IV inserted into R-AC. 125mg Solumedrol LOT DA6800 EXP 6/2022 (administered 1217) and 25mg Diphenhydramine LOT 049343 EXP 4/2021 (administered 1220) administered IV push per order.  Vitals obtained 1220- BP 122/50; HR 123; o2 99%. EMS arrived at 1225 to transport patient to ED.
Injection site redness 2 1/2" x 3", warm, swollen and painful. 48 hours after injection site is still bright red, warm, burning and throbbing at times.  Swelling and redness has spread to area 3 1/4" x 5" or more and painful.
3/26/21 3.5 hours after injection, dizzy, nauseous. 3/27/21 upon waking left arm muscle was sore from shoulder to elbow, had 3" diameter swollen area around injection site, very sore to touch, fatigued. 3/28/21 temp of 101 (normal is 97.6), knees ached, cold compresses/aspirin.  3/29/21 temp of 100, knees ached, cold compresses/aspirin. 3/30/21 temp of 100, knees ached, arm muscle pain has resolved. 3/31/21 temp of 99, swelling at injection site resolved, tenderness to touch at injection site reduced significantly, but remains, knees aching reduced, but remains.  Very apprehensive to receive 2nd injection for fear of being hospitalized/higher fever.  Noteworthy, weigh 100 lbs.
stroke; This is a spontaneous report from a contactable consumer (patient's brother). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter said that his brother passed away after receiving the vaccine and had a stroke on an unspecified date, and there was nothing wrong with him prior to that. The patient died on an unspecified date. It was not reported if an autopsy was performed. The reporter would like to know what exactly is in the shot and what the chemicals are that are in the shot. He has been recently notified that the FDA has approved the booster and wants to know what is in that one too.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. ; Reported Cause(s) of Death: stroke
Error occurred when administering a dose of the Pediatric Bivalent Vaccine. Clinic staff did not dilute vaccine prior to administration and so pt received concentrated vaccine. Estimated dose administered approx 28 mcg rather than the intended 10 mcg.   Patient/caregiver did not report any adverse event.
This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender who on 23-JUN-2015 was vaccinated with a dose of GARDASIL lot # K006960 for prophylaxis that were exposed to temperatures outside of the recommended range during 63 hours excursion. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
pt c/o lightheadedness & dizziness;pt feeling more & more poorly;T99.7;coughing quite hard, threw up;extremely cold;arthralgia & fatigue & discomfort of rt arm;delirious;AP 96, R26, T99.7
This spontaneous report as received from a registered medical assistant, refers to a 5 year old male patient. On 23-JUL-2014, the patient was vaccinated with an unspecified dose of VARIVAX (Merck) in the series, lot # J014228 (expiration date 08-NOV-2015) (route of administration was not reported). Concomitant therapies included IPV (unspecified), M-M-R II and DTaP. On 23-JUL-2014, later that evening, the patient's unspecified parent called the office to report that the patient developed a chicken-pox-like rash around his face. The reporter stated that the patient was then brought into the office on 24-JUL-2014, and the rash had spread to the patient's stomach and back. The patient was being treated with cooling lotion (unspecified) every 6 hours applied to the rash. Lab diagnostics studies were not performed. The outcome of event was reported as not recovered/not resolved. The relatedness between the event and VARIVAX (Merck) was not reported. Additional information has been requested.
Significant swelling (and some pain) under left armpit for 7-10 days. Swollen lymph node as per my individual assessment. Also, muscle twitching at several places in body for few days. Severe body pain for around 2 days.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Dec2021 as dose 3 (booster), single (Lot number: FL3197) at the age of 45 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 31Mar2021 as dose 2, single (Lot number: 008B21-2A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "POTS" (unspecified if ongoing), notes: POTS; "Ehlers Danlos syndrome" (unspecified if ongoing); "Interchange of vaccine products" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (dose 1 014M20A), for covid-19 immnunization; Moderna covid-19 vaccine (dose 2 008B21-2A), for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 10Jun2022 at 19:00, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Treatment start date was reported as 01Jun2022 and treatment stop date was 05Jun2022.
Parent wrote wrong DOB on our form which showed child was 12.  When entering into our vaccine registry, it was determined that the patient was really born in 2009 and only 11.  Family notified that they would not be receiving the second dose until child is 12.
Vaccine administered at 10:45am - went to living room where patient was brought out on hoyer lift by Brother and wife moved to living room at 10:50a. At this time he was unresponsive, pulse palpable but not countable. Resp. were 16, o2 sat was 44 w/pulse ox - continuous o2 at 10L - added nasal cannula to another tank - no change in pulse ox. Wife called EMS in the meantime. Wife put on portable vent, pulse ox was up to 51 - EMT ambulance arrived at 11:00a. They unhooked o2 to transport with a hoyer - they reconnected patient and he was loaded by 11:15a.   The 12/20/21 dose was a booster - previous vaccine given April 2021.
Patient recieved Dose #1 Pfizer from hospital.  Patient then scheduled for our clinic and received MODERNA vaccine for DOSE #2.  No adverse reaction to the 2nd dose vaccine at time of administration.
Rash at injection site, large lump under skin at injection site, swelling of left upper arm, and swelling of tongue.
cellulitis in 24 hrs w/malaise, t102 x 72 hrs; tx w/ATB's, IV's & pain meds
Decreased sensation and tingling began in my lower lip down to my chin on 10/5/21 @1220, and over the course of 24 hours spread to the rest of my body.  I contacted  my family doctor on 10/6, who requested I go to an urgent care for an in person neuro exam. The urgent care sent me to the ED to have labs drawn.  Around 1830, while I was in the ED waiting room I developed a 7/10 headache and had sensitivity to light.   I didn't have anything with me to take for the headache until they gave me a headache cocktail at about 1am. I'm 32 y.o. and have absolutely no hx of migraines. Today, 10/8, my extremities no longer have tingling and decreased sensation but my lower face still does have a little.  No more headaches since.
Headache, Myalgia, Fever, runny nose, pain injection site, chills, fatigue Narrative:
recurrent idiopathic hives since being vaccinated; recurrent idiopathic hives since being vaccinated; numbness in arm and face for 2 hours after vaccination; Pain when breathing 8 hours after vaccine; This is a spontaneous report from a non-contactable consumer (Patient). A 27-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot number was not reported) via an unspecified route of administration on 24Feb2021 (at the age of 27-year-old) as single dose for COVID-19 immunization. Previously patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot number was not reported) via an unspecified route of administration in left arm on 21Jan2021 as single dose for COVID-19 immunization.Medical history included psoriatic arthritis, idiopathic autoimmune hives, allergies to bactrim, penicillin, peanuts, shellfish, watermelon. Concomitant medications included Humira, prednisone, Zyrtec. It was reported that 1st dose facial numbness for 13 hours 2nd dose numbness in arm and face for 2 hours after vaccination. Pain when breathing 8 hours after vaccine Now have recurrent idiopathic hives since being vaccinated. AE treatment allergy medication included epi pen, allergy testing. Patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Patient has not been tested for COVID-19 post the vaccination as well as prior to vaccination. Outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.