chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Moderna 1st dose: 3Jan2021, 007M20A,Moderna 2nd dose: 28Feb2021, 022M20A; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna 1st dose: 3Jan2021, 007M20A,Moderna 2nd dose: 28Feb2021, 022M20A) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 007M20A) for COVID-19 vaccination.     Concomitant products included METHOTREXATE for an unknown indication.   On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna 1st dose: 3Jan2021, 007M20A,Moderna 2nd dose: 28Feb2021, 022M20A). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna 1st dose: 3Jan2021, 007M20A,Moderna 2nd dose: 28Feb2021, 022M20A) outcome was unknown.            No Treatment Medications were provided by the Reporter   This case was linked to MOD-2022-503979 (Patient Link).
Fever 102, body aches, fatigue, headache, enlarged lymph nodes in  armpit.
Headache, diarehhia, fatigue, muscle and joint pain, swollen lymph nodes (arm pit on side of injection), chest pain
11/5/02 Patient had complaint of dizziness and flu-like symptoms; denied rash, fever or difficulty breathing.
After injection patient experienced sore arm from vaccine followed by increased soreness/pain 2-3 days later. Patient followed up with physician for treatment of possible frozen shoulder (pain, soreness, tenderness and limited range of motion) and received MRI and steroid injection. Patient has continued pain and has scheduled physical therapy.
Narrative: Pt is a 72y.o. male who died on 01/30/2021 w/ h/o HTN, HLD, PVD, Hypothyroidism, DM, CKD3, GERD, CAD, CHF, cutaneous squamous cell carcinoma, and legal blindness. Pt received Moderna Covid-19 Vaccination 1/2 on 01/13/2021. Pt died at home on 01/30/2021. Unlikely that Moderna Covid-19 Vaccine caused/contributed to pt death.
I was diagnosed with follicular thyroid cancer in August of 2015.  The thyroid was removed and in November of 2015 I had one RAI iodine pill treatment.  Until March of 2021, my thyroglobulun tumor marker was normal,  reading < .1 ng/mL, but in March of 2021 it  read .1 ng/ml and has continued to climb, now reading 3.3 ng/mL.   I have had a radio iodine scan when it read 2.1 ng/mL  but it didn't show any cancer.  Now, 3 months later, I am scheduled for a PET scan in a few weeks.  The tumor marker did not  go up in value until I either possibly had COVID or the vaccine or both.
Was waiting 30 minutes due to previous anaphylaxis and tongue started to feel tingly, we administered 50mg of benadryl generic and held for 2 hour observation.   No sequelae.
Pt is immune suppressed, status post kidney transplant, and has CKD stage III.  He presented with increased shortness of breath.
Got shot got shingles/Suspected Vaccination failure; got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date :18 July 2022 Reporters comment: This case was reported by the patient via interactive digital media. The patient received Shingle vaccine and had shingles. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Muscle spasms / back spasm; discomfort; pain has significantly increased; muscle ache; joint pain; This spontaneous case was reported by a patient and describes the occurrence of MUSCLE SPASMS (Muscle spasms / back spasm), DISCOMFORT (discomfort), PAIN (pain has significantly increased), MYALGIA (muscle ache) and ARTHRALGIA (joint pain) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 from 23-Dec-2020 to 22-Jan-2021 and Chickenpox. Concurrent medical conditions included Diabetes, Blood pressure high, Obesity, Arthritis and Vitamin D deficiency.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MUSCLE SPASMS (Muscle spasms / back spasm), DISCOMFORT (discomfort), PAIN (pain has significantly increased), MYALGIA (muscle ache) and ARTHRALGIA (joint pain). The patient was treated with ACETAMINOPHEN for Pain, at a dose of 1 dosage form. At the time of the report, MUSCLE SPASMS (Muscle spasms / back spasm), DISCOMFORT (discomfort), PAIN (pain has significantly increased), MYALGIA (muscle ache) and ARTHRALGIA (joint pain) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Dec-2021, SARS-CoV-2 test: positive (Positive) positive.         The concomitant medication was not reported.   This case was linked to MOD-2021-264514 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: follow up received on 23-07-21 with Non-significant information.
Received PENTACEL, PREVNAR 13 and ROTATEQ 5/12/15. Developed fever of 104 degrees, rash and slight fussiness the following day that lasted 2 days. Parents reported symptoms to office on 8/4/15. Pt was taken to ER on 5/13/15. Advised to give TYLENOL. Pt recovered fully.
a 24 months old patient received a dose of flublok vaccine/No AE; Initial information received on 31-Oct-2019 regarding an unsolicited valid non-serious case received from a physician.  This case is linked to case: 2019SA309425 (same reporter).    This case involves a 24 months old patient (gender unknown) who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot number and expiry date not reported via unknown route in unknown administration site on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to inappropriate age at vaccine administration.  At the time of report 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.  Information on the batch number was requested.
24 hours after immunization patient had severe body aches, headache, weakness. Pt. had these symptoms for 2 days.
Pt was seen in clinic 7-24-2007 for an acute tonsillitis and I noticed a macular rash developing under both axilla, and hands.  Pt. was seen in clinic again 7-26-2007 and this macular rash had extended on the torso, back, arms, and legs to the knees.  Primarily a macular rash, blanches to pressure, non-pruritic, with some coalescing of lesions at the right knee.
Within 30 minutes she experienced her throat and breathing passages swell up, and there was no improvement after an Epi-Pen was administered (this happened 3 times and caused 3 hospital visits.)
Left ear fullness, then nausea and vomiting; dx. with otitis media Narrative: Symptoms resolved with steroids and antibiotics
infant given 2 month dose of Pediarix and a dose of Vaxelis; This non-serious case was reported by a nurse via sales rep and described the occurrence of accidental overdose in a 9-week-old female patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included VAXELIS for prophylaxis.   On an unknown date, the patient received Pediarix and VAXELIS. On an unknown date, an unknown time after receiving Pediarix, the patient experienced accidental overdose (Verbatim: infant given 2 month dose of Pediarix and a dose of Vaxelis).  The outcome of the accidental overdose was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 20-SEP-2023 The reporter reported that the 9 week old infant patient received 2 month dose of Pediarix and a dose of Vaxelis.  The reporter stated the error happened because the clinic was carying both DTap combo vaccines and the infant needed a HIB dose.  The medical assistant mistakenly gave Vaxelis instead of a single antigen HIB vaccine. Follow-up would not possible as no contact details were available.
Missed 2 1/2 days of work, 9/27/05 given TD tetanus shot in my left upper arm. Exactly one day later my neck and upper back begin to ache. My arm was extremely painful and swollen. 9/29/05 I returned back to doctor for chills, sweats, etc. Dr prescribed Vicodin and Bactrim DS still present and dark.
no adverse effects; unspecified number of unspecified patients have been administered doses of improperly stored vaccines; This spontaneous report as received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided.  On 27-MAR-2020, the patient was vaccinated with improperly stored doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) rHA, lot# S030206, expiration date on 24-MAR-2021 at a dose of 0.5 milliter, subcutaneously on the right tight.   There was no adverse effects reported.  Administered doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) experienced the temperature excursion between -14 and -10 degrees Celsius (-11.2C) for 3 hour and 42 minutes. Digital data logger was involved. There were no previous temperature excursions reported.   This is one of the several reports received from the same reporter.   This case comes from a case previously considered non-valid, but per new information received (patient identifiers) the case was splitted and determined to be valid for a specific patient.; Sender's Comments:  US-009507513-2008USA008875: US-009507513-2008USA008885: US-009507513-2008USA008882: US-009507513-2008USA008884: US-009507513-2008USA008890: US-009507513-2008USA008889: US-009507513-2003USA002275: US-009507513-2008USA008877: US-009507513-2008USA008879: US-009507513-2008USA008883: US-009507513-2008USA008886: US-009507513-2008USA008880: US-009507513-2008USA008881: US-009507513-2008USA008876: US-009507513-2008USA008917: US-009507513-2008USA008904: US-009507513-2008USA008933: US-009507513-2008USA008932: US-009507513-2008USA008903: US-009507513-2008USA008901: US-009507513-2008USA008931: US-009507513-2008USA008930: US-009507513-2008USA008900: US-009507513-2008USA008899: US-009507513-2008USA008928: US-009507513-2008USA008898: US-009507513-2008USA008927: US-009507513-2008USA008926: US-009507513-2008USA008925: US-009507513-2008USA008896:
This spontaneous report as received from a pharmacist refers to a 57 year old female patient. On 17-OCT-2014 the patient was vaccinated with ZOSTAVAX (subcutaneous in the left arm, 0l.65 ml, lot # K007989 EXP 03-SEP-2015; dose no. unknown). The same evening of the vaccination the patient developed redness at the injection site, pain, and swelling. By the next night on Saturday (18-OCT-2014), the patient had red, raised, fluid filled blister hanging outside the skin at the injection site. The reporting pharmacist stated he did not think it was shingles. The patient sought medical attention (in the pharmacy). The outcome of the events was reported as not recovered.  Additional information is not expected since there is no permission to contact physician.
Information has been received from a physician concerning a patient who in May 2008, completed the series of GARDASIL (lot # was not available).  In August 2008, the patient experienced seizures episodes.  At the time of recovering, the patient was recovering from seizures episodes.  Physician noted that the patient is blaming GARDASIL for her seizures.  The patient sought medical attention with the physician.  Telephone follow-up information was received from the nurse for the physician reporting that the physician not feel that the seizure was caused by GARDASIL.  The patient was seen in the ER, but not hospitalized.  Upon internal review, seizure was considered to be an other important medical event.  Additional information has been requested.
Painful numbing, tingling and swelling in hands.  Chest discomfort and shortness of breath.   Swelling and breathing issues resolved within a few days.  Numbing, tingling and pain in hands is slightly improved but ongoing.
Injected just under the bone; to high. With in 5 minutes a sharp shooting pain felt in Right shoulder extending down arm followed by a deep throbbing in deltoid and shoulder. This faded. Later in the day soreness like post shingles vax coupled with inability to move my arm, intense shoulder pain . Alternate ibuprofen and Tylenol, moist heat and rest. Today with 800 mgs of ibuprofen I can type but shoulder has limited mobility and is painful
Caller experienced a fever, headache, body aches, fatigue, nausea & vomiting over a 3 day period.
Injection site redness and swelling with itching, heat, and soreness. Dia 4 inches witnessed by reporter ar 9 am 12/07/2015.
He started having congestion, fever of 103, and a cough. He was also having a hard time breathing so we went to the doctor. He was diagnosed with Bronchiolitis. We were told to give him TYLENOL, ibuprofen and nebulizer when needed. This lasted about 10 days and then got sick again with a stomach virus. He was vomiting a lot, and then started having congestion. This lasted for about a week and then we noticed he was pulling on his ear, so we took him to the doctor and was diagnosed with an ear infection. He was given ofloxacin for this and we gave TYLENOL and ibuprofen as needed. He got better and then came down with a common cold and was given albuterol. We are still dealing with the common cold at this time.
Within one minute of receiving vaccine, I had shortness of breath and a racing heart.  The symptoms  lasted for about one minute then went away.
Rash on chest, face, back, arms, and upper legs. Gave triamcinolone cream 1% twice daily for 1 week only. ZANTAC 15 mg/1ml 1/2 tsp twice a day.
This spontaneous report was received from a health professional refers to a 19 month old patient. Current condition and medical histsory were not reported. On 27-MAR-2015 the patient received VAQTA 05 ml, intramuscular (lot # K009506, expiry date: 22-SEP-2016), that were improperrly stored. Concomitant medications were not reported. No adverse effects were reported. Outcome of the event, incorrec product storage was unknown. Reporting health professional considered the event to be not related to VAQTA. This is one of two reports received from the same source. Additional information has been requested.
Family caught COVID-19 starting last week, she woke up coughing wheezing and congested 18JUN2023 nebulizer was given to open airways and on 19JUN2023 COVID-19 Test-Positve resulted.  Sympytoms resolved within twentyfour  hours.
about 10 hours after getting the vaccine, i could barely walk.  Every joint in my body was sooooooo soooooo painful.  I broke into sweats, had chills, was cold, and had a bad headache.  But the joint pain was by farrrrr the worst.  It was EXTREMELY painful.  12 hours later the joint pain subsided.  I was all better withing 48 hours.  I had to report this though because the pain was severe.
Had insomnia and did not sleep at all for 37 hours. Then slept fitfully for 2 hours. The slowly went back to normal after 5 days or so. Some muscular soreness that has gone slowly down but am still minorly experiencing.
Information has been received from a physician and a health professional concerning a 71 year old male patient (weight 224 pounds, height 70 inches) with CODEINE allergy and diabetes who on 26-FEB-2009 at 09:30 am was vaccinated IM in his right deltoid with PNEUMOVAX.  At time of vaccination the patient had mild sinus congestion.  On 27-FEB-2009 the patient experienced cellulitis with fever, redness and swelling in upper arm of injection site.  The patient was examined in the emergency room but was not admitted.  On an unspecified date the patient recovered.  This is one of several reports received from the same source.  Additional information is not expected.
dizziness; headache; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number unknown), via an unspecified route of administration on 18Mar2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 18Mar2021, the patient experienced dizziness and headache. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
0625-Employee began to have elevated heartrate, heart pounding in her chest. Color pale. VS-HR-157, B/P-135/105. O2 sats-100% 0630-Ambulated to ED room. HR-148, B/P-150/83, O2sats-100%. Drank apple juice and ate a cracker. Experiencing dizziness, chills and heart racing. 0640-Hr-105-110, B/P-113/71, O2 sats-100%. Feeling better, shaking incontrollable chills. 0700-HR-104, B/P-121/79, O2 sats-100%. Spoke with ED physician-observe for 1 hour and reevaluate. Denies swelling, itching or difficulty breathing. Her mouth is very dry. Tolerating fluids without issues. 0715-HR-97, B/P-118/70, O2 sats-100%. Continues to experience waves of dizziness and chills. Episodes are spacing out further and not lasting as long. 0730-HR-90's, B/P118/70, O2 sats-100%. Tolerated ambulating to bathroom without problems. States just not feeling herself. Has opted to go to the clinic for evaluation. Assisted to clinic-tolerated ambulating without problems.
approx 11 days p/vax pt devel excessive bruising, petechiae in mouth, on lips, abd, and diaper area; unusual tiredness; ITP; tx w/WinRho
Patient s/p COVID vaccine Had reaction after 1st vaccine 3/25/2021 including nausea, cough and chest tightness Ended up having epi injections and brought to ER via ambulance Patient with sudden left sided hearing loss a couple days later Progressed over 1-2 more days then developed constant non pulsatile tinnitus + vertigo
Monitor for symptoms. No adverse events  O.3mLs given instead of 0.2mLs
DPT given right deltoid intramuscular.  2 minutes later developed pinpoint welt above site with mild redness and swelling.  Doctor was notified and checked patient immediately.  Advised to wait 15 minutes.  Ice pack applied.  2cm redness, 3cm swelling after 15 minutes some swelling on 04/04/2006.
9/14 at 10:40 I received a pneumovax syringe injection high on my left arm as did my husband. We returned home and in the next two hours my arm grew numb, began to throb and I experienced severe pain. I contacted my primary care physician but he was unable to see me right away. By 2 to 3 o'clock the pain was so intense I asked to be taken to the Hospital. The acute pain in my left arm persisted. I was administered an imaging test and EKG. I was discharged at approximately 8:00 p.m with instructions to take 400 mg. of motrin and 600 mg. of ibuprofen every eight hours and provided with a sling to use for 1 week. The severe pain persisted for 4 days. Since then milder pain persists daily. I am unable to carry heavy objects and soreness when raising my arm continues.
I had chest pain and shortness of breath. I was diagnosed at Health Resources with bilateral pulmonary embolisms. There's at least one embolism in each quadrant of my lungs.
Had extreme dizziness that lasted about 12 hours.   I was flush on my face and chest, skin turned red
pt broke out w/itchy, red rash @ site of vax which spread/larger in size w/elevate macules some confluent w/pale center in same extremity (lt thigh & lt buttocks); this happened 2 hr p/vax; few hives in opposite leg also;
Patient had SHINGRIX and Pneumococcal-23 vaccine on same day and developed temperature of 102, myalgias, and red rash.
Extreme soreness after first injection. After second injection, soreness moved to left shoulder which has been compromised as to motion. Unable to move shoulder as before injections.
This spontaneous report as received from a physician refers to a 13 month old patient. On 23-AUG-2017, the patient was vaccinated with M-M-R II (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On 23-AUG-2017, the patient experienced incorrect product storage. Sender's Comments: US-009507513-1708USA013219.
Patient indicated had not received covid vaccine before and requested moderna. Administered moderna and then found out upon processing she received 1 dose  pfizer on 7/29/21.
Persistent headache for the past week; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Persistent headache for the past week) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was provided.  Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Persistent headache for the past week). The patient was treated with IBUPROFEN for Headache, at a dose of 1 dosage form. At the time of the report, HEADACHE (Persistent headache for the past week) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient had persistent headache for the past week since she was administered with first dose of vaccination. As she did not have her vaccination card so was unable to provide lot and expiration date.
After the vaccine several symptoms. Then menstruation with a lot of fluid and lasts more days and in a short time repeated the period.
MD was summoned by MA because after giving the 4th vaccine, GARDASIL-9valent, the child slumped and was, for a few brief seconds, started to shake with open eyes staring ahead. Had the child lie down to relax. BP was low at 90/60 with a HR=58/min. Patient was advised to lie down. Patient admits she didn't eat lunch. She was given hard candy to lick after some 10 minutes, her cold, clammy hands became warm and there was a return of color to her pale lips. She was able to sit up and eventually walk to the bathroom on her own after about 25 minutes. She was discharged to return in 1-2 weeks to discuss and likely workup the episode. R/o syncope vs seizures vs postural hypotension vs neurogenic shock.