chrisvoncsefalvay/vaers-outcomes huggingface dataset:
mother stated he had the flu vaccine and dupixent injection close together; fever; got a little sick; Initial information received on 11-Nov-2021 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 9 years old male patient who reported fever, got a little sick and mother stated he had the flu vaccine and dupixent injection close together while receiving vaccine INFLUENZA VACCINE and while treated with DUPILUMAB [DUPIXENT] via prefilled syringe.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included COVID-19 VACCINE (COVID-19 VACCINE) for Prophylactic vaccination.  In August 2021, the patient started taking DUPIXENT (DUPILUMAB) Solution for injection at a dose of 300 mg QOW(every other week) via subcutaneous route,strength-300 mg/2mL (with an unknown batch number,indication).  On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for immunization.  On 01-NOV-2021 the patient developed a non-serious event "fever" (pyrexia) (unknown latency) following the first dose intake of DUPILUMAB and  INFLUENZA VACCINE.  On 11-FEB-2021 the patient developed a non-serious event "got a little sick" (malaise) (unknown latency) following the first dose intake of DUPILUMAB and  INFLUENZA VACCINE.  On an unknown date the patient developed a non-serious event "mother stated he had the flu vaccine and dupixent injection close together" (contraindicated product administered) (unknown latency) following the first dose intake of DUPILUMAB and  INFLUENZA VACCINE.  It was reported "Fever after flu shot for 24 hours while on Dupixent".  DUPILUMAB (DUPIXENT) was continued and Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the events (fever, got a little sick).  At time of reporting, the outcome was Unknown for the event fever, was Unknown for the event got a little sick and was Unknown for the event mother stated he had the flu vaccine and dupixent injection close together.  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.   Additional information was received on 11-Feb-2022 from consumer/non-Health care professional : frequency added for dupilumab, causality and action taken added for influenza vaccine and narrative amended accordingly.
Information has been received by a drug wholesaler representative concerning a patient who on 20-JAN-2009 was vaccinated with a dose of PNEUMOVAX (lot no. 659922/1667U). On an unknown date, the patient experienced several swelling in the arm and he could barely moved the swollen arm. The patient was hospitalized. Follow up information was received from the physician assistant who reported that the patient who had Hypertension and no known drug allergies. On 21-JAN-2009 the patient went to the doctor complaining of left arm and fingers swollen after vaccination subcutaneously with the second 0.5 mL dose of PNEUMOVAX vaccine in the left triceps area at 8:50 AM. The patient also had left elbow pain and had mild point of tenderness to injection area. There was no warmth or erythema. The patient had pain in a scale of 6/10 and the patient stated it was worst. There were no signs of infection. Physician assistant reported that the patient had used codeine (unspecified) for pain which helped. The patient also complaint of dry cough for 1 day. The patient denied nausea, vomiting and diarrhea, shortness of breath or chest pain. At the physical exam the patient was normal, blood pressure measurement: 130/70, heart rate 76 and temperature 98.2. The patient was advised to use warm comprises to area and do range of motion exercise. The patient was prescribed VICODIN tablets, 500 mg each 6 to 8 hours for pain. The patient was scheduled for a follow up one week after and he did not show up. No further information is available. This is one of several reports from the same source.
Patient experienced severe pain through arm and neck with redness, swollen and heat in the next day of receiving the vaccination and it lasted for 3 days.  Patient took pain medications and got better after that.  He is doing ok now.
Fever, headache, and chillls. Headache lasted 24 hours. Chills and Fever 12 hours.
Slight headache, fatigue, and chills starting the evening of 1/22/21 and continuing the next day (today).  Took an 8-hour Tylenol last night but still had headache this morning.
This spontaneous report as received from a pharmacist via Pfizer refers to a patient of unknown age and gender. No concurrent condition or medical history reported. On an unknown date in January 2014 (reported as last year), the patient was vaccinated with PNEUMOVAX 23. Approximately on an unknown date in 2014, the patient experienced arm pain at lot after the vaccination. The patient also enquired that would this happened on PREVNAR 13 as well. Action taken with PNEUMOVAX 23 was unknown. The outcome and causality was not reported. Additional information has been requested.
Child has red, swollen upper right arm, hot to touch, measures 110 x 112 mm. Also c/o sore throat, fever - 102, swollen cervical glands, tonsils. Given appt with doctor today, Given Keflex 250/3/7, Benadryl, Advil Sx Rx. Rtc if worse.
Per record, MMR administered at above name clinic 7/6/04. Pt 10 week pregnant at that time. Referral for perinatology consult.
On day 5 post second dose of COVID vaccine- developed fever, headache and muscle aches. Continued on day 6 and required a doctors visit.
Wheezing and shortness of breath 24 hrs after placement of PPD-ER visit. Fever and L deltoid pain 48 hrs after Td. The follow up received on 7/1/03 states 24 hrs after all 3 immunizations given pt developed fevers, L deltoid pain. CPK negative.
my arm is really sore; This case was reported by a consumer and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 19th August 2021, the patient received the 2nd dose of Shingles vaccine. On 19th August 2021, immediately after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: The case reported by patient himself or herself. The age at vaccination was not reported. It was reported that the patient just got 2nd dose of shingles vaccine and his/ her arm was really sore.
Client came in for booster dose and reported symptoms of SIRVA post 2nd dose administration of Moderna Vaccine.  Client reports intermittent shooting pain on right arm especially when sleeping on that side.  Recommended to visit PCP for treatment
Abdominal pain, vomiting, weakness, felt like passing out (symptoms) ER & hospitalization NG tube inserted Patient became septic w/elevated temperature, oxygen level dropped,  elevated heart rate & increased abdominal pain Surgery for small intestinal obstruction
25 minutes after administration, patient developed a lump in the throat, a swollen tongue, and chest tightness. On the recommendation of a co-worker (a doctor), she was told to take diphenhydramine.  Patient reported an ER visit on either days 1 or 2. On day 2, chest tightness remained, although the tongue swelling has subsided. Patient reported wheezing on days 2-3. Tongue swelled again on days 3-4.  Patient reported this on the evening of day 4 (9/23/21) and was still experiencing  mild symptoms.
hosp employee did not achieve acceptable titer level p/3rd vax w/Hep B vax;
Patient had a sore arm the night after vaccination, woke up with a red swollen deltoid muscle, rash and a blister at the injection site. Child felt headache, and dizzy the next, and missed school on day 3. Parents took child to a walk in clinic where child was given keflex and told to use ibuprofen. The following day a new blister appeared, and redness and swelling continued. Parents took child to family Dr. at this time where he was diagnosed with cellulitis and out on clindamycin, and a steroid antihistamine. Childs arm is healing at this time. Blisters are scabbed over and redness and swelling are decreasing.
Immediately had migraine headaches and extreme fatigue lasted until she was admitted to hospital on May 13th 2021. 2nd week in April diagnosed with sinus infection by tele health, put steroids' and antibiotics, 2 weeks later diagnosed with pneumonia. Diagnosed with pneumonia again on May 13th  also had generalized swelling, lymph node tenderness, After discharge on May 16th, swelling increased. Admitted again on June 7th swelling had became enabling, platelets are in 700,000 range fluctuating for four days from 700 to 650 and back up to 700. Hospital have ran several test, blood, liver, kidney and can not diagnose.
COVID Breakthrough Case  Pfizer Dose 1 2/6/21 (EL9266) Pfizer Dose 2 2/27/21 (EN6203) COVID Positive 11/28/21  11/28/21: The patient presents with weakness.  The onset was 2  days ago and gradual.  The course/duration of symptoms is constant and worsening.  The character of symptoms is generalized.  The degree at present is moderate.  Prior episodes: none.  Therapy today: none. Associated symptoms: none.  Additional history: none Patient states he has been coughing a lot over the past couple of days.  Supplemental history provided by a patient's 2 sons and daughter.  They states since he was seen here in the hospital 3 days ago he has been sleeping most of the time.  They state that they been waking him to feed him but he does not stay up along and then he just goes back to sleep and has hardly moved.  They states starting yesterday afternoon patient started coughing, and breathing fast  They states that the patient is a DNR per his request. Patient was admitted and respiratory distress with acute hypoxemic respiratory failure secondary to COVID-19 pneumonia.  Patient additionally had acute dehydration with acute kidney injury and rhabdomyolysis. Patient presented to the emergency department in moderate respiratory distress with the pulse oximetry only in the 60s.  Chest x-ray showed bilateral infiltrates.  Laboratory results showed acute kidney injury, severe dehydration and rhabdomyolysis.  Family reported patient is a DNR per the patient's instructions.  Patient was admitted initially on strict comfort care only patient's daughter who is power of attorney you/power of healthcare requests the patient be put on any medications that might possibly help.  Patient was started on remdesivir and dexamethasone and azithromycin and Rocephin.  Despite this patient's oxygen saturations did not improve.  Patient was somnolent when he arrived and slowly became unresponsive.  Patient was assessed and found to be not breathing and without a pulse at 11:20 p.m. and pronounced deceased
Severe arthralgias, myalgias, headache, nasal congestion noted within 12 hours
This spontaneous case reported by a pharmacist, describes the occurrence of administered expired product (patient received expired dose of the Moderna COVID-19 vaccine) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 068H21A) for COVID-19 immunization. No medical history reported. On Feb 17, 2022, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Feb 17, 2022, patient administered expired product (patient received expired dose of the Moderna COVID-19 vaccine). At the time of the report, administered expired product (patient received expired dose of the Moderna COVID-19 vaccine) outcome: unknown. The vaccine placed in refrigerator on Jan 13, 2022. The reporter did not provide any causality assessments, concomitant medication or treatment information.
Moderna Covid-19 vaccine given from a vial that had been punctured more than 12 hours ago; No adverse event; Moderna Covid-19 vaccine given from a vial that had been punctured more than 12 hours ago; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine given from a vial that had been punctured more than 12 hours ago), PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine given from a vial that had been punctured more than 12 hours ago) and NO ADVERSE EVENT (No adverse event) in a 63-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 041H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 15-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine given from a vial that had been punctured more than 12 hours ago). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine given from a vial that had been punctured more than 12 hours ago) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine given from a vial that had been punctured more than 12 hours ago), PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine given from a vial that had been punctured more than 12 hours ago) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine given from a vial that had been punctured more than 12 hours ago) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine given from a vial that had been punctured more than 12 hours ago).    No concomitant product use was reported.  The patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was reported that the Moderna Covid-19 vaccine given from a vial that had been punctured more than 12 hours ago. Vaccine was at room temperature for 18 hours after puncture. Dose given in the 18th hour.  No treatment information was provided.
Extreme diarrhea and vomiting for two days, nausea, weakness  Felt better after three days.
Around the beginning of June 2021, I began to get tingling, pins and needles sensations in my hands and feet. It comes and goes, and from just a little bit to being intense. There is no particular thing that I do that brings it on, or will stop it when it does start. It just comes and goes. I reported to my doctor on August 30, and she recommended that I make this report. She is going to schedule an appointment for me to have it checked out, but in the meantime, it is constantly annoying, so I am reporting.  (CONTINUING 9-Would not let me key on 2nd page) Levothyroxine, Pioglitazone, Amlodipine Besylate, Losartan, Simvastatin, Metoprolol Tartrate, Klor-com, Vitamin D, Tydenol, and Octavite
neck issue / excess inflammation in my neck and legs; neck issue; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced neck issue/excess inflammation in his neck and legs with outcome of unknown. The events were considered as non-serious. The patient stated "I got my 2nd Pfizer shot a week ago. On Friday late afternoon I got prednisone, or a neck issue. I didn't ask but doctor knew I had the vaccine -not when I got it though. Will it hurt the efficacy if I take the prednisone? I don't have any comorbidities. I'm taking it for excess inflammation in my neck and legs. I'm supposed to start it today. I start with 24mg then declines quickly."  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Fever, chills, muscle aches, skin sensitivity and redness/swelling at the site - symptoms are still on-going 1 week later.
Mom stated that patient felt sick the night of receiving the vaccine. Symptoms included soreness flu-like symptoms. The next day she had swollen eyes, cheeks and tongue swelling. Mom gave her BENADRYL and she was ok the next day.
5 X 4 CM  -  (CANNOT MAKE OUT)   AT VACCINE SITE
I got COVID-19 later December I had sore throat, chills, brain fog, cough, congestion and body aches.  I tested after a few days and then did a video call with a doctor and was given Paxlovid and within 24 hours I started to recover. About 7 days later I started to fully recover.
The patient states her arm was red and warm to the touch and it has now continued to spread toward her elbow each day
Full body inflammation, fever that would not go down with OT medicine , severe headache, stomach ache, fatigue that I am still experiencing 3 days later
ON 1/8/2005 PRESENTED IN THE OFFICE WITH SPOTS - FEVER BEGAN 3 DAYS BEFORE - EXPOSED TO CHICKEN POX 2 WEEKS BEFORE  DX: MILD CHICKEN POX STATUS POST VACCINE
An area of redness on my arm where vaccine was given.   Noticed on Tuesday this week.   It is bigger today
Improperly stored administered.; This spontaneous report was received from a certified medical assistant and refers to a 4-year-old female patient. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.   On 19-AUG-2020, the patient was vaccinated with improperly sored dosed of varicella virus vaccine live (Oka/Merck) lot # T002848 was confirmed to be valid, expiration date 23-JAN-2022 (exact dose, route and site of administration were not provided), for prophylaxis, which was reconstituted with properly stored sterile diluent (STERILE DILUENT) lot # S008566 was confirmed to be valid, expiration date was reported as but upon internal validation was established as 23-JAN-2022.  Administered doses of vaccine was multiple exposed to the temperature between -14 to 8 degrees Celsius (C) (-12.1 C) for 3 hours, from -9C to 8C (-7.5C) for 8 hours and 30 minutes. There was no previous temperature excursion. The call was because of a digital data logger
LARGE RED SPOT, HEATH AND ITCH AT SITE  OF INJECTION FEW DAYS AFTER RECEIVING VACCINE
Nausea x 2 hours Vomiting x 2 Watery diarrhea x10 in 2 hours Chilled for about 15-20 minutes  prior to vomiting  (I thought it may be from bag lettuce at lunch or leftover chicken soup from 2 days prior) Felt fine after 2 hrs Just reporting due to proximity of vaccine and I had severe nausea and diarrhea in April 2020 with Covid symptoms
Observed for 15 minutes after vaccine administration, no s/s of dizziness - lightheadedness; walked to car where mother states he passed out in passenger seat. Upon my arrival to car, pt had came to and sat up. Stated he felt lightheaded, gave juice, vomited after finishing juice, ate Nutri-Grain bar. No c/o dizziness no injuries mother and pt stated had not eaten today.
The pt. was receiving three shots at the clinic for upcoming travel.  Pt. was to receive Hep A, Meningococcal and Typhoid.  I administered Meningococcal and Typhoid and at the end of administering the Typhoid immunization the pt. started to jerk with eyes open and the incident lasted about 30 seconds.  pt. came to and was able to talk after about 30 seconds.  Her blood pressure dropped to about 82/60 during this time.  Physician was notified and came into the room advised blood pressure monitoring and gave the pt. some Coke as the pt. stated she had not eaten that morning.  Physician advised bp checks every ten minutes and to hold the Hep A immunization.  Pt. was released to home after about 30 minutes of observation.
Red, swollen and painful to touch on injection site (L) deltoid. Nausea 2 days. No vomiting, patient received prescription for promethazine 25 mg po every 8 hr and ibuprofen 800 mg q8hr. Follow up apt 11-21-18 with dr.
This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION SITE PAIN (Sore spot on his right arm of administration.) and FATIGUE (Little fatigued) in an elderly male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Concurrent medical conditions included Type 2 diabetes mellitus and Hypertension. Concomitant products included INFLUENZA VACCINE for an unknown indication.    In September 2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore spot on his right arm of administration.) and FATIGUE (Little fatigued). At the time of the report, VACCINATION SITE PAIN (Sore spot on his right arm of administration.) and FATIGUE (Little fatigued) had resolved.
Shingles 2 years after both doses of Shingrix/suspected vaccination failure; Shingles two years after receiving both doses of Shingrix at age 84 yo; Inflammatory arthritis; This case was reported by a physician via sales rep and described the occurrence of vaccination failure in a 84-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (received Zostavax 10 years prior to receiving Shingrix ).   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and inflammatory arthritis. The patient was treated with prednisone. On an unknown date, the outcome of the vaccination failure, shingles and inflammatory arthritis were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and inflammatory arthritis to be related to Shingrix and Shingrix.     Additional Information: GSK receipt date: 6-Jan-2023 Reporter's comment: The patient received Shingrix two doses around 81 to 82 years of age and experienced shingles two years after receiving both doses of Shingrix at age 84 years.  The patient was on a low dose of Prednisone (2.5 mg) for inflammatory arthritis. The reporter consented to follow-up via email. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the laboratory confirmation of shingles were unknown at the time of reporting.
Fever; chills; This is a spontaneous report from a non-contactable other health professional via a sale representative. A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on an unspecified date at a SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 for covid-19 immunization (first dose). The patient experienced fever and chills. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.