chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had no adverse effects or symptoms from administration; Patient is now 18 years old and got her second dose of HPV vaccine today, GARDASIL 9; the vaccine was expired; This spontaneous report was received from a pharmacist and referred to an 18-year-old female patient. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On an unknown date in 2015, when patient was 12 years old, she received the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis at clinic (strength, lot #, expiry date, and route of administration were not provided; 0.5ml/once). The patient had no adverse effects with that.  On 05-MAY-2022, the patient received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (strength, and route of administration were not provided; 0.5ml/once, lot #S022599, expiration date was reported as February 2022, upon internal validation, it was established as 25-FEB-2022) (inappropriate schedule of product administration and expired product administered). After administration, the staff realized the vaccine was expired. The reporter did not have exact expiration date as vial had been discarded and expiration date was documented only as February 2022. The patient had no adverse effects or symptoms from administration. Dose had no prior temperature excursions and was supported per post-expiry memo.
I started having burning and tingling all over my body that was nerve pain. I called my PCP because I had a similar reaction to my flu shot last year. She advised me to start taking the gabapentin that I took last year after my flu reaction.   Then I was referred to a Neurologist, and it was determined that I have Small Fiber Neuropathy. I was put on the 2 medications, that made me too sleepy. The medications are amitriptyline and duloxetine I have a follow up appointment today.
Having severe problems with blood sugar levels spiking; Fatigue; nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIABETES MELLITUS INADEQUATE CONTROL (Having severe problems with blood sugar levels spiking) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Type 2 diabetes mellitus. Concomitant products included GLIPIZIDE for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced DIABETES MELLITUS INADEQUATE CONTROL (Having severe problems with blood sugar levels spiking) (seriousness criterion medically significant). April 2021, the patient experienced FATIGUE (Fatigue) and NAUSEA (nausea). The patient was treated with GLIPIZIDE for Loss of control of blood sugar, at an unspecified dose and frequency. At the time of the report, DIABETES MELLITUS INADEQUATE CONTROL (Having severe problems with blood sugar levels spiking), FATIGUE (Fatigue) and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Apr-2021, Blood glucose: high as 360 (High) Blood sugars have spiked up as high as 360. On 27-Apr-2021, Blood glucose: high as 360 (High) Blood sugars have spiked up as high as 360.         Action taken with mRNA-1273 in response to the events was not applicable.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-095793, MOD-2021-095337 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Reporter details were updated; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
a few days after the shot i was having a hard time breathing, made appointment with Pulmanologist he ordered a ct scan but no ultra sound. ct scan showed no clots in the lungs at that time. Woke up a day or two later with severe back and leg pain was transported to the emergency room. I was then transported to   facillity because i could not move my left leg and was in severe pain. During my stay i coughed up a blood and requested the doctor to do blood work. The blood work showed high levels of clots. I was not taken to the hospital or treatment for the clots at that time. When i left the facility i saw my Doctor she ordered immediatly another ct scan of the chest and an ultra sound
Began to have Covid symptoms again; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Began to have Covid symptoms again) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Psoriatic arthritis and Drug allergy. Concomitant products included ETANERCEPT (ENBREL) for an unknown indication.   On 04-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (Began to have Covid symptoms again). At the time of the report, COVID-19 (Began to have Covid symptoms again) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient after finishing course of Paxlovid, I felt great for 2 days and then began to have COVID-19 symptoms again and symptoms include sinus pain, congestion and significant back pain and body aches. The patient took other medications/products within 2 weeks of starting COVID-19 treatment. No treatment medications were provided. Company comment: This spontaneous case concerns a 43-year-old female patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of special interest COVID-19. The event occurred 222 days after administration of third dose of mRNA-1273. There was no information regarding the initial two doses. It has been reported that the patient's condition improved after finishing a course of Paxlovid and then began to have COVID-19 symptoms again and symptoms include sinus pain, congestion and significant back pain and body aches. Details of clinical course and outcome were not provided. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 43-year-old female patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of special interest COVID-19. The event occurred 222 days after administration of third dose of mRNA-1273. There was no information regarding the initial two doses. It has been reported that the patient's condition improved after finishing a course of Paxlovid and then began to have COVID-19 symptoms again and symptoms include sinus pain, congestion and significant back pain and body aches. Details of clinical course and outcome were not provided. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
complain of pain in site of area 6 inches, no swelling or redness or bumps
Patient woke 5/16/2019 and noticed pink rash about size of orange under vaccine site. The rash was flush with skin and had small blister/crusty area
Vaccine #3 in series provided too soon. No S/S. Patient contacted and informed next dosage should be on or after January 1st.
States entire arm reddened down to fingers, soreness. Resolved over next 48 hrs.
9-28-11 became dizzy & lightheaded after HPV vaccine administered, site of varicella injection swelled immediately after administration, mother states T 101 degrees that evening with diarrhea & fatigue. 9-29-11 T high 102 degrees mom took to ED, cont with fatigue, diarrhea, red at injection site & appears to have pus at varicella injection site.
Vaccine: Zostavax - Merck - given on 2/13/08; According to patient - on 2/15, site was red "rash" and itching. Also somewhat swollen. No allergies to neomycin/gelatin or otherwise. Resolved without problem.
Patient reports racing heartbeat, diaphoresis x 2 days, reported to hospital with a HR of 75, but was instructed by Hospital for patient to have VAERS filled out.
I developed cold like symptoms December 24th. I got tested for covid December 27 about 4 pm (negative) My blood pressure was over 140 in one arm so she did it again in the other arm and it was 134.  that was about 1 hour before the attack. After becoming emotionally upset my heart raced and pounded without slowing or decreasing in intensity for approximately 30 minutes and then flopped in my chest for about 30 seconds to a minute.  I laid down in bed the whole time. I couldn't talk. Breathing was labored. I prayed and tried to slow heartbeat by calming down and relaxing through it all.  afterwards I was afraid to move.  I stayed in bed for about 14-16 hours and rested.  I felt pains in my chest area on occasion when rolling over or moving.  My left arm was tingly and achy until January 9, 2022. I had another racing heart incident that only lasted about 5 minutes but I layed down again.  I took a baby aspirin the evening of January 8th. It hasn't hurt since then.  I had an abnormal ekg on January 6 showing I had a heart attack.
Information has been received from a health professional concerning a 65 year old female with no pertinent medical history who on 10/14/05 was vaccinated intramuscularly in the left deltoid with a 0.5ml dose of Pneumococcal 23v polysaccharide vaccine (lot 650648/0967P). there was no concomitant medication. There was no illness at the time of vaccination. Following vaccination (date not specified) the pt experienced upper arm swelling to the elbow, redness at the injection site and skin was warm to touch at the injection site. Unspecified medical attention was sought and no lab or diag test were performed. It was reported that the pt recovered. No product quality complaint was involved. Additional information has been requested.
Patient started to feel lightheaded. Not first time this happens to him.  Has history of feeling faint with blood draws and vaccinations.  Was escorted to cot from chair and felt better.  Blood pressure 122/78, 120/72,and 122/76, Respirations 16 Pulse 72. After one hour and drinking water and taking short walk patient felt well.  Stated that he felt well enough to drive home. Was observed total of one hour.
Mother reported, when child awakened in the morning, his R arm was "red, swollen and warm half way down to his elbow." Mother treating with Tylenol advised her to contact pediatricians no further treatment ordered.
27OCT93 c/o soreness day of shots; 29OCT93 c/o swelling lt arm; 1NOV93 sore lt shoulder & hard to lift lt arm above head;
Immediate aching in jaw, painful to chew and open mouth wide.  Now, I am experiencing tinnitus - started about 6 weeks ago.
Pt complains about lightheadedness. Did not eat this morning before reporting to the clinic.
CLIENT STARTED TO EXPERIENCE PAIN BEHING THE RIGHT KNEE ON 4/13.  WORK WITH GREATER PAIN AND DIFFICULTY BENDING IT TODAY.  SAW PCP TODAY AND SOME SAMPLES WERE TAKEN AND CLIENT WAS INSTRUCTED TO ONLY MONITOR FOR OTHER SYMPTOMS AND IF WORSEN TO CONTACT PCP OR ED. PCP INSTRUCTED TO TAKE ACETOMINOPHEN IF NEEDED. PAIN REMAINS THE SAME AT THIS TIME.
patient received another flu shot (not sure when or what she was given) but was given FLUBLOK today with no AE; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via Medical Information (MI) (Reference number- 00355246) and transmitted to Sanofi on 11-Nov-2020. This case involves female patient [age unspecified] who received another flu shot (not sure when or what she was given) but was given 0.5 mL dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] today [lot number and expiry date not reported] via an unknown route at an unknown administration site on 11-Nov-2020 for prophylactic vaccination (extra dose administered).  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided   It was an actual medication error due to wrong vaccine administered (latency: at the time of vaccination).  Product used : Used  Still using product : No  At the time of reporting, no adverse event was 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 available on the batch number for this case.
Deep vein thrombosis in right leg first noticed 3 weeks after booster shot; pulmonary embolism in right lung; was tested on 26Apr2022 per PCP's recommendation for factor V Leiden, results showed Positive - Heterozygous for factor V Leiden mutation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 23Nov2021 at 09:00 as dose 3 (booster), single (Lot number: FJ8762) at the age of 60 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: IRON; SAW PALMETTO BERRY; MULTI-VITAMINS VITAFIT. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Right), administration date: 14Apr2021, when the patient was 59-year-old, for Covid-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Right), administration date: 26Mar2021, when the patient was 59-year-old, for Covid-19 Immunization. The following information was reported: DEEP VEIN THROMBOSIS (medically significant) with onset 14Dec2021, outcome "recovering", described as "Deep vein thrombosis in right leg first noticed 3 weeks after booster shot"; PULMONARY EMBOLISM (medically significant) with onset 14Dec2021, outcome "recovering", described as "pulmonary embolism in right lung"; FACTOR V LEIDEN MUTATION (non-serious) with onset 14Dec2021, outcome "recovering", described as "was tested on 26Apr2022 per PCP's recommendation for factor V Leiden, results showed Positive - Heterozygous for factor V Leiden mutation". The events "deep vein thrombosis in right leg first noticed 3 weeks after booster shot", "pulmonary embolism in right lung" and "was tested on 26apr2022 per pcp's recommendation for factor v leiden, results showed positive - heterozygous for factor v leiden mutation" required physician office visit. The patient underwent the following laboratory tests and procedures: Factor V Leiden mutation: (26Apr2022) Positive, notes: results showed Positive - Heterozygous for factor V Leiden mutation. Therapeutic measures were taken as a result of deep vein thrombosis, pulmonary embolism, factor v leiden mutation. Clinical course: The patient had an annual physical with PCP on 02Nov2021 with no problems or concerns noted. He was taking Blood thinners for 3 months as treatment. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
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 POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021 at 10:17 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 08-Feb-2021 at 10:17 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, 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, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (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.   The age of patient was provided as 74.15.  No concomitant medications were reported.  On 08-Feb-2021, excursion time was 10 AM, temperature was 29 and 11 AM, temperature was 35. Total doses given for the day was 30, condition of vaccine prior to administration was not frozen. The vial was initially moved to the fridge on 02-Feb-2021 and beyond use date was 04-Mar-2021. 3 vials were sent to clinic on 08-Feb-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  No treatment medications were reported.
Rash under the boob same side of the injection site, rash began to spread, was diagnosed with Shingles by healthcare provider. Was prescribed Famciclovir and pain medication.
expired product administered; This spontaneous report was received from nurse concerning a 4-year-old male patient of unknown race.  The patient's medical history included infection. The patient's concomitant medications included albuterol and ranitidine hydrochloride (ZANTAC). The patient's concurrent conditions included asthma, upper respiratory tract infection, pneumonia and streptococcal infection. The patient had no drug reactions or allergies. The patient's historical drugs included 4 doses of pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13) and unspecified antibiotics for infections.  The patient was under physician's care (clinician unspecified) for history of asthma, recurring upper respiratory infections, pneumonia, streptococcus infection ("strep"). The clinician decided to evaluate the patient's immune function and drew titers in recent past and titers came back low. Treatment for this was to vaccinate with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). The patient underwent a comprehensive metabolic panel (results not reported).  On 01-MAY-2019 (also reported as 19-APR-2019) the patient was vaccinated intramuscularly with an expired pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # N025384, expiration date 19-APR-2019, for "low titers for pneumococcal" (prophylaxis) (strength was not reported).
Pain to the large muscles (legs, back, neck) and joints about 16 hours after injection. Overall fatigue and headache about 18 hours after. I took two 325mg aspirin for the headache, which only slightly helped.  About 24 hours after the injection, the symptoms continued and now included chills.  36 hours after the injection, the symptoms continued and I took Oscillococcinum, which slightly helped.
Approx  6 pm  i experienced  chills and sever right shoulder pain ( shot was given in left arm) and Fatique. that lasted 1 1/2 days. A few day later i noticed small red spots on my lower left leg along with the original lesion and some on my back. Notified my PCP of severe right shoulder pain. Had  x ray done DX with  arthritis. 3/17 went to see a dermatologist and was DX with Plauque Psoriasis. was  prescribed Triamcinolone Acetonide ointment 0.1% and ref. to Rheumatology . Due to the Psoriasis and new DX of Arthritis. Saw Derm again on 4/28 due to sever spreading of Psoriasis all over body. Was given prescription of Betmethason Dipropionape 0.05% Started to have right knee pain and swelling. X ray done also increased in right shoulder pain Mri done Psoriasis is spreading more and right shoulder and knee pain continie.
5 doses were administered expired yesterday 14Oct2021; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 doses were administered expired yesterday 14Oct2021) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 doses were administered expired yesterday 14Oct2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5 doses were administered expired yesterday 14Oct2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.
First became dizzy, then lightheaded. Became diaphoretic and pale. C/O seeing black. Upon standing immediately stated, "I can't breathe" wheezing noted. 100mg liquid Diphenhydramine HCL taken orally. Albuterol inhaler 3 puffs. 10 minutes later, respirations easier, continued to be diaphoretic and pale. 10 minutes later no longer pale, slightly diaphoretic, hand and arm tremors noted. Statement, "hand, feet and face tingling and itching", "tongue feels funny". Tongue noted to be slightly swollen. 1 hour post injection, respirations WNL, no further C/O swelling or tingling, no longer diaphoretic or dizzy. Statement, "tired". Refused F/U /c Emergency Services or Primary Care.