chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received his 3rd dose despite not being immunocompromised; Received an expired dose; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (received his 3rd dose despite not being immunocompromised) and EXPIRED PRODUCT ADMINISTERED (Received an expired dose) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 028A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Sep-2021, the patient experienced OFF LABEL USE (received his 3rd dose despite not being immunocompromised) and EXPIRED PRODUCT ADMINISTERED (Received an expired dose). On 07-Sep-2021, OFF LABEL USE (received his 3rd dose despite not being immunocompromised) and EXPIRED PRODUCT ADMINISTERED (Received an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was provided by the reporter.  Patient received 3rd dose despite not being immunocompromised. Patient entered the lot number of third dose into the Moderna online Expiration Date Lookup tool and it showed that that lot expired on 28Apr2021. Patient received the first 2 doses from doctor, and the lot of 1st dose is missing from the card.
On Saturday Mar. 20th, I had my 2nd dose of the Pfizer vaccine.  Approximately 3:00 AM, March 21, I had a very severe reaction to the vaccine causing extreme pain in my belly and lower back. (Mainly my lower right back) The pain was exactly like my kidney stone pain...so painfully intense.   Although trying to manage the pain with 2X 500 mg of acetaminophen every 6 hours, I was throwing up, pacing, rocking and becoming so weary of how was I going to get through this.  A fever of 101.5 started sometime on Sunday and fluctuated but was no higher than 101.7.  A heating pad  helped to ease the pain and I was able to get some sleep until the flare up would start all over again.  This continued throughout the day for 17 hours.   By Monday , March 22, morning the intense pain was gone and my body was recouping.  My stomach was achey from either the intense pain or the vomiting.  I continured to run a fever of 101.  until Tuesday afternoon, March 23.
Redness, swelling, warm, tender to touch at site approx 24 hrs after administration. At 220pm 09-19-12 area measured & marked. 9-20-12 area remains reddened, swollen, tender & warm to touch 3" x 3". Instructed to use cold compress & call 24 hrs.
SADDLE PULMONARY EMBOLISM HYPOTENSION PULMONARY EMBOLISM W INFARCTION, UNSPECIFIED
Localized swelling and itching at injection site. Grew to size of "hockey puck" by the time patient reported to pharmacy on 11/7/14.
Narrative: 1) hives all over/big welts-all over arms,shoulders,chest,stomach,back redness,itchy Transfer to RN - ongoing x Moderna shot yesterday Unable to screen for COVID 19 due to BAT symptoms. Nurse Notes: COVID vaccine - Hives all over body. Has had immunization in the past, without any difficulty. Pt states that he has hives that are all over his body, and spreading as well as hived on his neck, no difficulty swollowing at this time, but reports that he feels slightly short of breath.
Headache, trouble swallowing, hoarseness, Redness in both eyes and muscus, muscle aches, chills, drank plenty of fluids and stayed in bed.
pt recv vax & pt awakened from nap 40min prior to coming back to office;pt pale w/ eye stare;
mild fever; This is a spontaneous report from a contactable consumer (patient). A 33-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 15Mar2021 at 09:30 as dose 1, single for covid-19 immunization. The patient medical history included hypothyroidism. The concomitant medications included ibuprofen (ADVIL 12 HOUR). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. On an unspecified date, the patient had experienced mild fever. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Itching; Inflammation of the face with small bumps, painless but itchy; Inflammation of the face with small bumps, painless but itchy/some lumps on his face on his cheeks and under his jaw; Swollen lymph nodes; Rash; Hives; Swelling of the face; acute allergic reaction; lymphopathy; This is a spontaneous report from a contactable consumer (patient). A 69-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Injection), dose 1 via an unspecified route of administration, administered in Arm Left on 24Jun2021 18:00 (Batch/Lot Number: EW0196) at age of 69-years-old as single dose for COVID-19 immunization. Medical history included high blood pressure from an unknown date and unknown if ongoing. No known allergy. Concomitant medication included metoprolol received within 2 weeks of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility the most recent COVID-19 vaccine administered was pharmacy or drug store. The patient experienced swollen lymph nodes, rash, hives and swelling of the face on 25Jun2021 with outcome of unknown, inflammation of the face with small bumps, painless but itchy/some lumps on his face on his cheeks and under his jaw on 25Jun2021 07:00 with outcome of not recovered, itching on 25Jun2021 07:00 with outcome of recovered in 2021, all reported as medically significant. AE resulted in Emergency or urgency room/department. Treatment to against allergy was received. Clinical course reported as follow: Patient received the first shot of the Pfizer Covid-19 vaccine on 24Jun2021 and the next day he had an allergic reaction. He went to withheld Hospital in withheld to the emergency room because his face was swollen and he had some lumps/"bumps" on his face on his cheeks and under his jaw. The treatment he received was diphenhydramine (BENADRYL) 25 mg oral capsules, oral tablets (2 tablets a day for 4 days); Prednisone 20 mg oral tablets, and Hydrocortisone topical 0.1% cream. He had to take 2 tablets of Prednisone 20 mg for 4 days. He took the treatment for 3 days and now has stopped it. He no longer has the itching he previously had. He had internal swelling on the face, like if the swelling was coming from his glands. He currently has no itchiness swelling was internal, like lymph nodes. The diagnosis the doctor gave him was acute allergic reaction (2021) and they described it as itching on the face and swelling. He was due to get his second dose of the COVID-19 vaccine on 15Jul2021. He needed to explain that the swelling on his face was supposed to be on his neck but because of an allergic reaction, he got this on his face. It was called lymphopathy (2021). The lymph nodes were supposed to come out on his neck but nothing came out on his neck, they came out on his face was what the doctor were informed. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
DAPTACEL was given early. Last dose of DAPTACEL was third dose on 5/24/17. Was supposed to get PREVNAR this visit, and received #4 DAPTACEL instead.
Fever up & down day of shot & inc ea hr; temp no greater than 102 but that arm was the size of an orange, states mom;
This spontaneous report as received from the physician's assistant refers to unspecified number of patients of unknown age and gender. No concurrent conditions, medical history or allergy/drug reactions were reported. On an unknown date, the patients were vaccinated with improperly stored oral, ROTATEQ lot # K024700 with expiry date: 30-JUL-2016, (dose not reported). No concomitant medication was reported. No adverse effect reported. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
-Varicella vaccine #2 given 6/14/07 -onset of vesicular rash on (L) side of neck 6/16-6/17 -No fever, no pain, mild itching.
Approximately 1 week post injection of yellow fever and twinrix #1 immunizations the pt developed a perineal abscess and later diagnosed w/ shingles. Client was told by PCP that twinrix may have brought on Shingles despite already receiving shingles vaccine.
pain; rash on leg; This spontaneous case was reported by an other (subsequently medically confirmed) and describes the occurrence of RASH (rash on leg) and PAIN (pain) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, the patient experienced RASH (rash on leg). On an unknown date, the patient experienced PAIN (pain). The patient was treated with TRAMADOL ongoing since an unknown date for Pain, at an unspecified dose and frequency. At the time of the report, RASH (rash on leg) had not resolved and PAIN (pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported .   Reporter did not allow further contact
Friday 01/10/03 developed rash on torso/no fever. Mother called CDC  with instructions to take to hospital, was seen in ER @ 9:30 p.m. by that time the child was crnaky and itchy. Hospital in contact with CDC with instructions to put on prednisone and benadryl. On Sunday 01/12/03 3 am vomited with fever of 102. Mother gave tylenol on Monday 01/13/03 temp. was 99 and feeling better.
Initial report received from a healthcare professional on 20 June 2013. A 28-year-old female patient, had received an intramuscular dose 1 of ADACEL vaccine (lot number C4327AA) in right deltoid on 20 June 2013. The patient was pregnant at the time of vaccination. last menstrual period date was unknown. The estimated date of delivery was 05 September 2013. The patient's health during pregnancy, risk factors (e.g. alcohol, tobacco or recreational drugs) and treatment for infertility were unknown. Concomitant medications were not reported. At the time of the report, the patient had not experienced any adverse events. Documents held by sender: none.
a 22-year-old male is requesting revaccination with VARIVAX as he has had titers drawn and had a negative titer "for everything".; This spontaneous report was received from a pharmacist concerning to a 22-year-old male patient. The patient's concomitant therapies were not reported, he had no medical conditions or known allergies.  The patient was fully vaccinated (unspecified) as a child, however, the vaccines and dates when these products were administered were not reported nevertheless he never had an issue.   On an unspecified date, the patient was vaccinated with a dose of varicella virus vaccine live (manufacturer unknown) (reported as the pharmacist does not know if patient received varicella virus vaccine live (VARIVAX) or another varicella containing vaccine) and sterile diluent (manufacturer unknown) for prophylaxis (indication reported as lack of titer, doses, strengths, lot #, and expiry dates were not provided).   On an unspecified date, the patient had antibody titers (unspecified) drawn by the air force, nevertheless, he had a negative titers results for varicella and everything else (antibody test negative), as reported both by him and his mother. He was revaccinated for some other negative titers (unspecified) "at another clinic" and for this reason he was now requesting revaccination with varicella virus vaccine live (VARIVAX) (it was stated by the reporter, that although the patient did not specified which varicella virus vaccine was received or what tests were negative, the report was submitted for  varicella virus vaccine live (VARIVAX) as a precautionary measure, since it was the only vaccine, that the patient was requesting), it was reported that there was no treatment given for the event (conflicting information, it was reported that revaccination with other products was received), further information was not provided. At the reporting time, the outcome of antibody test negative was unknown.  The causal relationship, between the suspect vaccines and the event of antibody test negative was not provided.
first dose >35 days ago; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-Jul-2021 and was forwarded to Moderna on 07-Jul-2021.    This spontaneous case was reported by a patient and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (first dose >35 days ago) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (first dose >35 days ago). In January 2021, PRODUCT DOSE OMISSION ISSUE (first dose >35 days ago) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatments were provided.   Reporter did not allow further contact
mom states pt recvd vax 11AM & on way home started crying high pitched cry; pt had this high pitched cry on & off for 3 days & had a fever of 101.8 for 3 days; mom gave APAP every 4 hrs for 3 days also; exp hi pitched crying was 1 hr;
p/DTP had t104.9 ax & pt was lethargic; mom called on call physician-APAP & tepid;
Immediate severe swelling, redness of entire left forearm-vital signs stable and no other signs of allergy/anaphylaxis.  Treated with cool pack and observed for an additional 30 minutes with no other symptoms. Redness resolved in approximately 3 hours post vaccination.   3 days later on 11/21 child developed episodes of being hot, heart racing, shortness of breath, and red/blotchy patches on face.  No fever, chills  or GI symptoms.  It looked almost like "panic attacks or anxiety" per mother's report.  Seen by Pediatrician at Clinic on 11/29 but all tests were normal.  Referred to mental health clinician.  Episodes have resolved at this time-12/9/21.
I am a health care professional and received my first vaccine 12/17/20.  I had the my first reaction on 12/19/20.  Horrible fatigue, body aches.  My second dose was given on 1/7/21.  After 6 hours, I felt myalgias, arthralgias, skin sensitivity to anything that touched me.  Severe fatigue and headache.  Took Tylenol with no relief.  The worst day hit at 1/8/21 at 3:00 a.m.  I could not move without extreme pain.  Sweating and chills.  No appetite.  Had to be assisted to toilet.  Tried to go into hospital to do vaccine clinic today, 1/11/21 and had to return home as I was extremely fatigued and excessive sweating.
Approximately 10 minutes after the vaccine, patient became tachycardia hr 110, diaphoretic, and pale. Felt back to normal around 12:30 pm. Patient did not develop any additional symptoms until Saturday evening around 5pm when similar symptoms developed but milder.
IMZ ADMINISTERED AND PT HAD IMMEDIATE INJECTION SITE REACTION - KNOT FORMED, SWELLING, PAIN, HEAT. ICE PACK APPLIED. AFTER 5-10 MINUTES THE SWELLING/KNOT WENT DOWN. PT THEN COMPLAINED OF ARM TINGLING - WEAKNESS. PATIENT WAS OBSERVED FOR 30 MINUTES. NO OTHER REACTION OBSERVED. PT DID CHECK HER INSULIN PUMP WHILE SEATED AND BLOOD SUGAR WAS 269 - BUT REPORTED THAT SHE DID EAT A PIECE OF CANDY TO PREVENT HYPOGLYCEMIA. PATIENT WAS WITH HER SPOUSE, WHO WAS DRIVING TO AND FROM THE PHARMACY
Pt developed hives over entire face requiring visit to ER. Tx with Benadryl x 2d.
I have been sick/I am still not feeling right; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "I have been sick/I am still not feeling right".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous case was reported by an other health care professional and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (Could not move shoulder for 3 days), VACCINATION SITE MOVEMENT IMPAIRMENT (limited range of motion), BURNING SENSATION (burning sensation in my deltoid,sensation goes down to the elbow), ROTATOR CUFF SYNDROME (Rotator cuff tendinitis) and PAIN (pain got really intense) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Penicillin allergy. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (limited range of motion), PAIN (pain got really intense) and VACCINATION SITE PAIN (injection site pain). On 15-Jan-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (Could not move shoulder for 3 days), BURNING SENSATION (burning sensation in my deltoid,sensation goes down to the elbow), ROTATOR CUFF SYNDROME (Rotator cuff tendinitis) and ARTHRALGIA (Soreness in the left arm). The patient was treated with IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDE (MOTRIN COLD & FLU) for Pain, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL DISCOMFORT (Could not move shoulder for 3 days), VACCINATION SITE MOVEMENT IMPAIRMENT (limited range of motion), PAIN (pain got really intense) and VACCINATION SITE PAIN (injection site pain) had not resolved and BURNING SENSATION (burning sensation in my deltoid,sensation goes down to the elbow), ROTATOR CUFF SYNDROME (Rotator cuff tendinitis) and ARTHRALGIA (Soreness in the left arm) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant products were not provided by the reporter. This case was linked to MOD21-09517 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Patient demographics, vaccination facility details, second dose information and event outcome were updated.
On 3/18/2021 at  7:00 pm I lost my vision in my right eye I went to the ER  where they did blood test and Ct scan to my head and they send me to a different Medical Center because they don't have vision specialists. In the Medical Center they examine my vision and they recommended me to  go to see Dr.  at his office in the morning. Next day I went to the Dr. , he examined my eye and he told me there is a blood in my back eye and he recommend to see another Dr.  I went immediately to the other Dr . and she  diagnosed retinal vein occlusion and she gave me a shot in my eye
Swelling and redness of injection site, warm to touch. Patient noticed the morning after injection after removing band-aid. Patient will keep a close eye and report any worsening. Will also try triple antibiotic ointment.
This spontaneous case was reported by a consumer and describes the occurrence of DYSPHAGIA (couldn't swallow), PAIN IN EXTREMITY (arm hurt) and LYMPHADENOPATHY (lymph nodes swelled) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Multiple sclerosis, Stress, Depression, Itchy (Ears gets itchy), Arm discomfort (Arm Hurt), Swallowing difficult, Memory loss (Memory getting worse), Exacerbation of infection of skin, Drug hypersensitivity (Keflex), Drug hypersensitivity (Diflucan), Latex allergy, Gluten sensitivity, Reaction to coloring (artificial colors), Reaction to flavoring (artificial flavor), Milk allergy and Drug hypersensitivity (Suprex Allergy). Concomitant products included OCRELIZUMAB (OCREVUS) for an unknown indication. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPHAGIA (couldn't swallow), PAIN IN EXTREMITY (arm hurt) and LYMPHADENOPATHY (lymph nodes swelled). At the time of the report, DYSPHAGIA (couldn't swallow) had not resolved, PAIN IN EXTREMITY (arm hurt) outcome was unknown and LYMPHADENOPATHY (lymph nodes swelled) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided by the reporter.
no additional AE reported; A dose of GARDASIL 9 that experienced a temperature excursion was administered to a patient; This spontaneous report was received from a nurse practitioner referring to a patient of unspecified age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 09-AUG-2021, the patient was vaccinated with an improperly stored dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # T029522, expiring on 13-MAR-2022, 0.5 milliliter for prophylaxis (route and site of administration were not reported). The administered dose of the vaccine experienced a temperature excursion of -4.8 degrees Celsius for 20 minutes. The vaccine had not had any previous temperature excursions.  There was no adverse effect reported. No product quality complaint was involved. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: T029522; expirationdate: 13-MAR-2023; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Pt school would not let him return without a meningococcal vaccination. Meningococcal vaccination given to patient. When patient's report was printed, it showed Pt received meningococcal vaccination 08/11/2020. Per CDC site, patient should get booster between ages 16-18. Mr Krug is 4 months away from 16th birthday.  Pt  was discharged without reaction. Will patient need booster between ages 16-18?
Pooped massive amount of blood; This is a spontaneous report from a non-contactable consumer (patient).   A 21-year-old female patient received bnt162b2 (BNT162B2), at the age of 21-years at vaccination, dose 1 via an unspecified route of administration, administered in Arm Right on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The patient is not pregnant at the time of vaccination. On 24Mar2021 12:00, patient pooped massive amount of blood with outcome of unknown.    Information about lot/batch has been requested.