chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pain has moved to abdominal area; Diarrhea; Upper back pain; Chills; Nausea; Vomiting; Fatigue; Sweats; This case was reported by a consumer via call center representative and described the occurrence of chills in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received in November of 2019, experienced tiredness, refer case US2020AMR087932).   On 1st March 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 1st March 2020, immediately after receiving Shingrix, the patient experienced chills, nausea, vomiting, fatigue and sweating. On 6th March 2020, the patient experienced upper back pain. On an unknown date, the patient experienced abdominal pain and diarrhea. On an unknown date, the outcome of the chills, nausea, vomiting, upper back pain, abdominal pain, diarrhea, fatigue and sweating were unknown.   It was unknown if the reporter considered the chills, nausea, vomiting, upper back pain, abdominal pain, diarrhea, fatigue and sweating to be related to Shingrix.  Additional details were provided as follows: Immediately after getting the vaccine on right arm the patient experienced chills, nausea, vomiting, fatigue and sweats for 24 hours.  About 5 to 6 days after he developed pain in the upper portion of his back.  The patient went to see his physician for the upper back pain.  The back pain had moved to abdominal area.  The patient was also vomiting and had nausea at least once a week.  The patient was also experiencing diarrhea.  All of the side effects keep coming and going except the fatigue and pain the abdominal or back area which were constant.  No other details were provided.  Caller reporting adverse event for herself and her husband.  The reporter consented to follow up.  This case is 1 out of 4 cases reported by the same reporter.      Lab Comments: The patient had cat scan of chest and stomach.  The patient also had blood panel work to rule out fibroid, and any other effects on liver, kidneys and pancreas.
12/27/2020: fever, chills, headache, body aches, joint pain, fatigue 12/29/2020: headache, body aches, joint pain, nausea, vomiting: started on doxycycline 100mg BID at ED 1/12/2021: completed doxycycline 1/13/2021: fever, chills, headache, bodyaches, joint pain: restarted on doxycycline 100mg BID 1/19/2021: completed doxycycline 1/20/2021: fever, chills, headache, bodyaches, worsening joint pain 1/22/2021: ED for blood cultures, x rays, CMV, Mono spot, Epstein barr 1/27/2021: consult with doctor who concluded this is from COVID vaccine
Within 5 minutes of receiving flu shot, dizzy, short of breath, heart pounding, tunnel vision, numb lips, tremors. Symptoms continued to worsen over the next several days, requiring 3 trips to the emergency room for chest pain, chest pressure, dizziness, tunnel vision.  Misdiagnosed as anxiety attacks, later confirmed as adverse reaction by primary care provider. Symptoms of chest pain and pressure still occurring 3 weeks post vaccine.  Taking Mobic for possible pleurisy d/t vaccine.
Patient came to pharmacy 10/27/16 complained of arm from flu shot being red and bruised around vaccination area. Arm also felt warm to the touch. Patient will follow up with PCP.
soreness at & around injection site - mild swelling; soreness at & around injection site - mild swelling; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26May2021 12:45 (Lot number: EW0180) at the age of 50 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Arythmia" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Chronic fatigue" (unspecified if ongoing); "IBS" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; LIOTHYRONINE. The following information was reported: VACCINATION SITE SWELLING (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 26May2021 18:00, outcome "recovering" and all described as "soreness at & around injection site - mild swelling". Therapeutic measures were not taken as a result of vaccination site swelling, vaccination site pain.  Additional information: Facility where the most recent COVID-19 vaccine was administered was pharmacy or drug store. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
No adverse event, wrong  dose given . Was given Moderna Bi-Valent .25
pt recvd vax in 1990 & JUL93 had neg titer; No further details were provided;
Patient said she woke up in the middle of the night with terrible headache said "it felt like her brain was swelling" and her joints were super achey. She said she felt as though she couldn't move. Tried to call her son, but didn't have the strength.
Fever of 104, not responding to infant Ibuprofen.  Up to 1 1/2 days prior, child's personality was a bit off (fussy and not eating as well), but no other health-related adverse symptoms.  Fevers remained for 6 days, gradually becoming less severe and became less frequent.  Appetite and
89-year-old female presented to the emergency department complaints of weakness and dark stool.  Patient unable to provide much history herself.  She was at the facility for the past 2 weeks after treatment for COVID-19.  patient was found to have hemoglobin of 6.1.  She also noted to have SIRS due to non infectious process with acute organ dysfunction, hyponatremia, hypochloremia, hypoalbuminemia, transaminitis, and type 2 MI with elevated troponin.   4/06/2021 tested positive 5/4/2021 tested positive 5/4/2021: patient discharged.
PT TURNED RED, HOT, FLUSHED, REPORTED TIGHT THROAT AND DIFFICULTY BREATHING.  CALLED 911, HAD PT LAY ON FLOOR, COLOR STARTED RETURNING TO NORMAL, BP 144/81, HR 100.   PT WAS SITTING IN CHAIR WHEN PARAMEDICS ARRIVED, FEELING MUCH BETTER.  PT WALKED OUT OF PHARMACY ~ 15 MINUTES LATER.  DAD WILL CALL WITH UPDATE
Fever, headache, body aches, chills, nausea- feels like when I had COVID (October,2019) but WORSE
Vaccine administered to pregnant patient; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine administered to pregnant patient) in a 38-year-old female patient (gravida 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025M20A and 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Ex-alcohol user (Prior to pregnancy 3 drinks/week.).   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 20-Jul-2020 and the estimated date of delivery was 02-May-2021. On 23-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine administered to pregnant patient). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-sixth week of the pregnancy.  On 20-Feb-2021, EXPOSURE DURING PREGNANCY (Vaccine administered to pregnant patient) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Aug-2020, Pregnancy test: positive (Positive) Positive. On 15-Dec-2020, Ultrasound foetal: unknown (normal) normal.         Concomitant product use was not provided by the reporter.  The patient's estimated date of conception was 06 Aug 2020.  No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.
Breakthrough case admission after 4 vaccines Moderna 3/3/21 Lot# 030A21A;  Moderna 3/31/21 Lot# 017B21A;  Moderna 12/2/21 Lot# 077C21A;  Moderna 4/28/22 Lot# 005M21A
Pediatric patient received Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Pediatric patient received Moderna vaccine) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Pediatric patient received Moderna vaccine). On 11-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Pediatric patient received Moderna vaccine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant information was reported. Treatment information was not provided.
5 days after Covid vaccine dose 1 I experienced pain on the left side of my torso, On the evening of day 6 I noticed a quarter sized rash under my left arm, On day 7 was diagnosed with Shingles; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number and expiry date not reported), via an unspecified route of administration, administered in Arm Left on 22Apr2021 12:00, (at the age of 57-year-old) as dose 1, single for COVID-19 immunisation. Medical history included Multinodular goiter under control and Penicillin allergy. Concomitant medication included levothyroxine sodium (LEVOTHYROXIN) which the patient received within 2 weeks of vaccination. Prior to vaccination the patient was not diagnosed with COVID-19; did not receive any other vaccines within 4 weeks prior to the COVID vaccine and patient had not been tested for COVID-19 post vaccination. On 27Apr2021 07:00 (also reported as 5 days after Covid vaccine dose 1), the patient experienced pain on the left side of torso. On the evening of day 6 the patient noticed a quarter sized rash under left arm. On day 7 the patient was diagnosed with Shingles and started medication. The patient visited physician office and was treated with Antiviral medicines due to the event. The patient recovered from the event in Apr2021.  Information about Lot/batch number has been requested.
Ten minutes after receiving vaccination patient stated she was feeling hot.  Patient face  was red with red blotches to her chest. Patient was moved to private exam and mask removed for breathing, patient given ice pack for heat and water to drink. Patient took two 25mg Benadryl at 3:12 p.m. V/S taken at 3:12 b/p 178/90, r 22, P 64. Patient complained of numbing sensation to nose and mouth.  3:28 Patient blotches to chest lessened and states she is feeling better.3;30 patient V/s taken b/p 158/78,R 50 P 64. Patient states numbness to mouth less. Patient stated she frequently takes Benadryl for her allergies and does not tire from. Patient is talking fine and drinking water. Clinical director talking with patient and assessing. Patient is talking fine and gait is steady. Denies difficulty breathing or swallowing. No slurring of speech respiration steady. Patient requests to leave at 3:45 p.m.
He had a heart attack two months after receiving the shot. They had to put a stent in. He had blood clots they didn't know where they were coming from. One month later, July 12, he had another heart attack that killed him. They put him on a ventilator and after they removed that he was doing fine. Then they put him on rendezevere. It filled his lungs with fluid and he was gone in 12 hours. They murdered him.
pt given immun 7/21/99;the evening of 7/22 pt crying hard/not consolable, felt warm/intense cry x few hrs;mom out of room heard funny nose;pt spitting up nose/mouth no jerking;seen in ER felt not sz;
Vaccines were administered at approximately 8:40 AM. Patient's temperature was 100 around 11:00 AM at home. Shortly after 11:00 AM patient had seizure. Patient's mother called 911, patient was taken to ER by ambulance.
Approximately 2 minutes after receiving Pfizer COVID vaccine booster pt c/o dizziness and seeing floaters, was taken to stretcher by vaccination nurse. Spoke with pt who stated she was now experiencing chest discomfort - described as an ache 5-6/10, no diaphoresis noted skin w/d to touch, respirations even and nonlabored, placed into wheelchair and taken directly to the ED. Pt states she has anxiety and a hiatal hernia. Pt experienced anxiety after first vaccination and stayed in vaccine clinic until felt better. Report to ED triage nurse and physician. Dizziness
This 58 year old employee received annual influenza vaccine to her left deltoid with a Biojector 2000 disposable cartridge jet injector on 8/23/2011. Approximately 15 minute later her left shoulder and arm began to hurt as felt with previous vaccinations. Within 4 hours she complained of increased pain with lifting left arm requiring use of MOTRIN, and she stated she left work. Over the next 12 hours complained of increased site tenderness, site swelling with redness and nodule formation (dime size) and pain (7/10) when moving her left arm. (Unable to lift cups or objects with arm outstretched, pain moving arm over her shoulder). She was self treating with ice packs to site and used MOTRIN every 6-8 hours with some relief (5/10). Approximately 36 hours (while at work 8/24/2011) despite above therapy, her left upper arm vaccine site was hot to touch, tender with redness and swelling from the top of left shoulder down to left elbow and did not encircle the arm. Her sleeves fit tightly in her blouses/jacket and the vaccine site had a "large knot" about quarter size. She took BENADRYL 50 mg with some relief that evening and was able to sleep. She denied any fever, nausea, itching, chest pain, shortness of breath or any angioedema other than to left upper arm. On 8/25/2011 she presented to the immunization clinic with above site reaction being referred to Occupational Health and then the ER being diagnosed with cellulitis to left deltoid. She was instructed to treat with NSAIDs and ice/hot packs and given a prescription for KEFLEX to use in 48 hours if no better. She returned to immunization clinic and was referred for VAERS and vaccine adverse event. On my exam (8/25/11) her left deltoid was hot and tender to touch with diffuse erythema and swelling to upper anterior 1/2 left arm. She had a triangle shaped erythematous area 10cm width x 12cm length x 20cm surrounding an oval 10 cm length x 12 cm width edematous region just under her vaccination site (scab from injection noted at top of edematous area). She had full ROM and good sensation to her left arm/hand/fingers with grips strong and equal bilaterally. She had a strong radial pulse and capillary refill <2 seconds. There were 1-2 small mobile non-tender left axillary lymph nodes to palpation.
Pt recvd Engerix-B inject & 48 to 72 hrs p/dose, pt exp a rash on both arms, chest, back & abdo; rash described as red & raised;
Doesn't recall exact vaccine date, except between 10/4 - 10/8. On 10/12, began severe tremors in all extremities - especially on right side. Progressed within 8 - 10 days to complete inability to walk. Continues to require max. assist to transfer from bed to chair. Has seen the neurologist twice. No testing done for possible Guillian barre. No diagnosis made.
Mastitis- child is almost a year and hadn't had Mastitis since she was 1 months old
mom stated pt cried 20min p/immun & all afternoon & noc;fever peaked @ MN @ 104;had been given APAP;this AM noticed rash under skin or mottling all over body x/face, worse on stomach,chest,back;pt doesn't want to lift arms;referred to MD
patient received Fluzone Quadrivalent accidently instead of Fluzone Quadrivalent High Dose /no AE; Initial information received on 17-Sep-2020 regarding an unsolicited valid non-serious case received from a pharmacist.   This case involves a 94 years old male patient who was accidently vaccinated with INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLZ QIV T] instead of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (wrong product administered).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  concomitant vaccination(s) were unknown.   On 17-Sep-2020, the patient received 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  This was an actual medication error case due to wrong vaccine administered (latency: on same day).  Reporter wanted to know if the patient should be revaccinated. Pharmacist reported that she did not realize the pharmacy received Fluzone Quadrivalent and the pharmacy only had the High-Dose before she left. The error was not discovered until after the dose and the box was being put away.    At the time of report, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  There will be no information on the batch number for this case.
Patient stated she felt dizzy, but she also stated she always feels dizzy, given one Benadryl tablet, waited 30 minutes and felt fine before leaving
Information has been received from a physician concerning a 59 yr old female who in approx 2005 was vaccinated with her first dose of pneumococcal 23v polysaccharide vaccine. In Jan 2006, the pt was vaccinated with the second dose of pneumococcal 23v polysaccharide vaccine. In Jan 2006, the pt developed an injection site reaction. The physician reported that the pt's arm was swollen and red. The pt sought unspecified medical attention. At the time of this report, the pt had recovered from the events (date unk). Additional information has been requested.
COVID 19 treatment; COVID 19 treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Nov2021 as dose 3 (booster), single (Lot number: FF2593) at the age of 65 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 25Jun2022 as dose 4 (booster), single (Lot number: 058A222A) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID 19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE
A report has been received from a Health Professional concerning a 10 year old, male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. The patient's medical history included lung disease. The patient's concurrent disease(s) included bronchospasm and asthma. Family history included asthma and sinusitis. FLUMIST QUADRIVALENT started on 21-Oct-2013. The patient experienced pneumonia. FLUMIST QUADRIVALENT was discontinued on 21-Oct-2013. The outcome of the event of pneumonia is unknown. The report was considered to be non-serious.
MMR #2 (or possibly 3) given IM in left deltoid in error; pt stated it hurt more than any other shot she had ever received
keratosis of the cornea; corneal abrasions; blurred vision; This case was reported by a consumer via call center representative and described the occurrence of keratosis in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2019, the patient received the 2nd dose of Shingrix (intramuscular). In February 2019, less than 2 months after receiving Shingrix, the patient experienced keratosis, corneal abrasion and blurred vision. The patient was treated with valaciclovir hydrochloride (Valtrex) and ophthalmologicals (Eye Drops (Nos)). On an unknown date, the outcome of the keratosis, corneal abrasion and blurred vision were unknown.   It was unknown if the reporter considered the keratosis, corneal abrasion and blurred vision to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced eye problems in Feb 2019 and in April 2019 was diagnosed with keratosis of the cornea and subsequently diagnosed with corneal abrasions with associated blurred vision. The patient was on Valtrex and other eye drops to treat the issue. The reporter consented to follow up.
My menstrual cycle in March 2021 was only 18 days long. It lasted March 14-31. I did have the common cold at the time. On March 22, I had hysterosalpingogram attempted, but the doctor was unable to do the procedure.
Patient called 8/8/21 stated had developed a red rash and warmth at injection site.  Advised patient to apply cool compress, take Benadryl as indicated on product package and apply hydrocortisone cream if she needed.
Myocarditis.  Patient developed chest pain symptoms 1 day after his third booster dose.  Symptoms progressed to the point of requesting ER evaluation over the course of the next 24 hrs.  There he was found to have EKG abnormalities with concern for possible acute coronary syndrome.  He was taken to testing with a finding of normal coronaries.  Troponin was noted to be elevated.  Echo demonstrated mild LV dysfunction.  Cardiac MRI pending at this time.
Patient went in and out of consciosness and temporarily lost sight. Patient left in  an ambulance.
?COVID Arm?- swelling, tenderness, warmth at site of injection. Dispersion of rash/redness masked by upper arm tattoo.  Common side effects: headache- low grade headache with onset at vax +1 day. Persisted to current (vax +8 days). Sore arm- initial date of injection.
Patient got shot around 1:30pm, called me at 4:30pm said arm was sore and it hurt to raise it up, put ice on it -use Ibuprofren/Tylenol.
Information has been received from a physician concerning a 7 year old male pt who on 4/29/97 was vaccinated with varicella virus vaccine live. On 2/8/00, the pt developed a "full-blown case of chickenpox". It was not known if the pt was febrille. Unspecified medical attention was sought. Additional information has been requested.