chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swelling, tenderness, redness left upper arm. Decrease ROM left arm requiring pt; Motrin, Flexeril, ice.
Patient passed away; This case was reported by a consumer via patient support programs and described the occurrence of unknown cause of death in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death.   The reporter considered the unknown cause of death to be unrelated to Shingrix.  Additional details were as follows: The age at vaccination was not reported. The patient's history was unknown. The patient received Shingrix and died. The cause of death was unknown and autopsy performed was unknown.; Reported Cause(s) of Death: unknown cause of death
administered an expired ACT-HIB dose to a patient with no reported adverse event; Initial information received on 29-Aug-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 15 month old male patient who was administered an expired HIB (PRP/T) VACCINE [ACT-HIB] dose to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine conj (Pneumococcal Conjugate Vaccine) for Prophylactic vaccination (immunization).  On 28-Aug-2023, the patient received a dose 0.5 ml of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection lot UJ802AA expiry date: 14-Aug-2023 via intramuscular route in the left thigh for immunization and was administered an expired act-hib dose to a patient with no reported adverse event (expired product administered) on the same day following the administration of HIB (PRP/T) Vaccine.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event administered an expired act-hib dose to a patient with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Neck pain; Shoulder pain; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Neck pain) and ARTHRALGIA (Shoulder pain) in a 71-year-old female 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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NECK PAIN (Neck pain) and ARTHRALGIA (Shoulder pain). At the time of the report, NECK PAIN (Neck pain) and ARTHRALGIA (Shoulder pain) outcome was unknown.            Concomitant medication list was not provided. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.
Initial report received from a healthcare professional on 02 November 2012. A 43-year old male patient, whose medical history and concomitant medications were unknown, had received an intradermal dose of FLUZONE ID (batch number UT4474AA) in the right arm on 31 October 2012. On 01 November 2012, 1 day after vaccination, the patient developed a red raised area 4.5 inches surrounding the site. Corrective treatment and laboratory details were not reported. At the time of this report, the patient had not recovered. List of documents held by sender was none.
I contracted COVID-19 on 06/16/2022 with symptoms of scratchy throat, congestion, and runny nose. I tested negative on my first visit to urgent care on 06/16/2022 and was told to take Zyrtec. On day 3 of my illness I went back to urgent care where I tested positive, and was prescribed Paxlovid. I was ill for 5 days before my symptoms began to resolve. The Paxlovid left a metallic taste in my mouth, but I am now fully recovered.
Approx. 6-8 hours after receiving TDAP pt. developed fever, chills, nausea. Within 12-24 hours she had redness & rash at site of injection - generalized myalgias.
pt recv vax & devel inj site rxn of redness,swelling,tenderness & a lump.  Tx w/ice.
Developed rash on back, stomach, arms, leg. Went to doctor.  Took allergy test. Not allergic to food, etc. Given Benadryl and Allegra.  Had to be on allergy medication for about a month.
Patient has developed shingles on back and legs within 7 - 10 days of receiving 2nd dose of Pfizer COVID-19 Vaccine.; This is a spontaneous report from a contactable consumer.  A non-pregnant 68- year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on Feb2021 (Batch/Lot number was not reported) as 2nd dose, single (at the age of 68 years old) for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 for COVID-19 immunisation.  The patient has developed shingles on back and legs within 7 - 10 days of receiving 2nd dose of Pfizer COVID-19 Vaccine on Feb2021. It was unknown if the patient received treatment. The outcome of the event was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained
Infant stopped babbling, looked at us as though he did not know who we were, began gazing, stopped eating, was irritable, not cuddly, had disturbed sleep problems, began surface scanning objects, crossing eyes, and was diagnosed with autism spectrum on 8-10-05. Medical record states congenital abnormality. msv Encephalopathy, speech and language regression, cognitive impairment, autism, gilobal dev. delay severe egg & peanut allergy, severe GI issues.  This should not be a mandated vaccine.  Our twins received this vaccine at 6 months and just shy of 7 months.  Parents should be informed. Follow-up: Patient still has a dx of regressive encephalopathy w/ features of autism.
Patient has been battling recurring fevers since the day after vaccine up until today (3/29/23 - 4/3/23). His whole arm is red. Parents took him to his PCP today and he began Orapred therapy for 5 days.
the site of injection was "hard and warm"; the site of injection was "hard and warm"; This spontaneous report was received from a medical assistant and refers to a 64-year-old female patient. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported.  On 15-JAN-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), lot number: S029265, expiration date: 31-MAR-2021 (strength, exact dose and route of administration were not provided) for prophylaxis.  On 15-JAN-2020, the patient's site of injection was "hard and warm". She sought medical attention, coming back to the reporter's office on 16-JAN-2020. The patient received prescription for an unspecified antibiotic.  The outcome of the events was not recovered/not resolved (reported as ongoing).  The relatedness between the events and the suspect vaccine was not provided.
Extreme Fever, 102.2 Severe chills Severe Headache Arm sweilling & pain- Severe redness and spreadedto elbow- Took temp of arme 102
Severe left arm pain. MRI was performed which showed edema and suggested adhesive capsuilits.
This spontaneous report was received from two medical assistants refers to an unspecified number of patients of unknown age and gender. Pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On unspecified dates the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX, (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). No adverse effects reported. Concomitant therapies were not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Clinic doctor she had spoken too experienced ringing in his ears after the booster shot of Moderna; This spontaneous case was reported by a patient and describes the occurrence of TINNITUS (Clinic doctor she had spoken too experienced ringing in his ears after the booster shot of Moderna) in a male patient of an unknown age who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (Clinic doctor she had spoken too experienced ringing in his ears after the booster shot of Moderna). At the time of the report, TINNITUS (Clinic doctor she had spoken too experienced ringing in his ears after the booster shot of Moderna) outcome was unknown.     The action taken with mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.  Concomitant product use was not provided by the reporter.  Caller stated that when she went to visit her ENT doctor for the tinnitus, she was told by the doctor that this was not the first time he had heard of this reaction after the vaccine and that other people had similar complains as well.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-644953, US-MODERNATX, INC.-MOD-2022-644901 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-644953:Case for Other People (AC) US-MODERNATX, INC.-MOD-2022-644901:Case for ENT doctor
Hives all over the body, treating with xyzal or zyrtec. Symptoms started Day 13 after booster shot
pt recv vax & devel herpes zoster which was 1 1/2 inches in size, located on lower back & painful;4/20/98 pt seen by a MD & began tx w/acyclovir;
Pt given vaccination that was opened and left at room temperature since 02/04/2022.
Left upper arm red, swollen, "hot to touch".  Patient states headache, dizzy spells.  Referred to Emergency Room.
RN filled out Pharmacy Requistion form for Vaccines requesting Tdap. Pharmacy Technician gave RN DTaP instead of Tdap, the pharmacist who checked it did not recognize it was the wrong vaccine. RN received DTaP and did not recognize it was the wrong vaccine and it was given to patient. RN called to enter lot number into our system and pharmacy technician could not locate and discovered it was for the wrong vaccine (DTaP and not Tdap). Pharmacist called RN to ask which vaccine she had and realized she had given wrong vaccine to patient. Patient was also revaccinated with correct Tdap.
20mins p/vax pt had urticaria, wheezes, c/o flushing of face pruritus, dyspnea;
Patient reported increased redness, swelling, heat at vaccination site in left deltoid in the days prior to dx with cellulitis on 5/20/12.
Rash at the site of the vaccine, about 2 inches in diameter, appeared 10 days after vaccine administered,
Severe redness entire left arm and much of left chest, general tiredness and some faintness occurred.  Rash lasted about 10 days weariness lasted 7-10 days.  Improving.
Received vaccine 2-3 days before visit at PCP office, site, of injection became red and tender to touch. Today in clinic dxd with cellulitis and tx'd with KEFLEX. Shot was for meningitis but mom doesn't recall which one. Pt seen on 5/24/14.
Gave last shot, (HPV) and patient turned white, and said she was hot and patient fainted while sitting in chair, called for help, patient responsive and reoriented. Patient sat in clinic 30 min. afterwards and mother drove patient home.
Achy around 3 am, nausea, almost passing out/nodding off, extensive nausea/vomiting from 8 am to 5 pm (inability to eat without vomiting), 101-102f fever, arm/shoulder/upper back pain pain on left side (still have arm pain 72 hours later)
Delayed cutaneous hypersensitivity - some swelling, redness in a circle around the injection site, and itchiness. The spot is also tender in a similar way to tenderness present directly after getting the first dose. It is ongoing at this time, but only started two days ago.
Information has been received from a registered nurse concerning a 5 year old male patient with no past medical history who on 17DEC1998 was vaccinated with a first dose of varicella virus vaccine live, SC, in the left leg. Concomitant therapy that day included a first dose of measles virus vaccine live+ mumps virus vaccine live + rubella virus vaccine live (second generation), SC, in the right leg, and a third dose of oral poliovirus vaccine. There was no illness at the time of vaccination. Subsequently, the patient "came down with chickenpox" .On 07JUN2003, the patient developed a fever of 99.9F, diarrhea and greater than 75 lesions (also reported as "spots") on face and trunk. The patient was seen in the office on 09JUN2003. The physician told the mother to give symptomatic treatment of diphenhydramine HCL (benadryl), acetaminophen (Tylenol) and oatmeal baths. On 11JUN2003, the patient was reportedly "beginning to recovery" and had "no other symptoms related to varicella exposure." It was also reported that this child was exposed to other children with chickenpox. At the time of this report one other patient was reported to have a similar experience. Additonal information has been requested.
Client at clinic accompanied by mother and father for 2 month immunizations. Client properly identified by name and DOB. Client properly screened for allergies (food/medication) and medical conditions. Explained to mother and father what vaccines are to be received. Nurse began by first  administering Rotavirus vaccine via oral administration. No adverse reaction. Patient tolerated Rotavirus vaccine well. Nurse then proceeded to administer Vaxelis combination vaccine intramuscular to right vastus lateralis. No adverse reaction noted. Patient tolerated Vaxelis vaccine well. Nurse then proceeded to administer PCV vaccine intramuscular to left vastus lateralis. No adverse reaction noted. Patient tolerated  PCV vaccine well. Nurse then administered Varicella vaccine subcutaneously on left arm. No adverse reaction noted. Patient tolerated Varicella vaccine well. Nurse advised mother and father of possible side effects of vaccines and what precautions to take if necessary. Mother, father and patient were then escorted back to main lobby to await finalization of paperwork. Nurse then acquired that the Varicella vaccine was not indicated for this patient and a medication error was made. LVN was notified, as was Nurse Supervisor. The mother and father were called back in to discuss the medication error and its possible side effects. Nurse and RN viewed all three injection sites and determined they were within normal limits. Patient was observed for 30 minutes with no adverse reaction noted. Mother and father were encouraged to inquire any questions they have before departing.
Itchy, red, puffy hives on stomach, inner leg, backside of knee, and ankle. Nine in total
PT HAVING BREAK OUTS ON THE BODY SPECIFICALLY 2 SPOTS ON LEFT LEG AND FOREHEAD
upon awakening headache, progressed to temp of 104.5 the same day taken to ER, refused admission, resolved in 48 hours with Tylenol and ibuprofen administration
Pt states that he had some shingles eruptions on his toes after vaccination. He has spoken with pain specialist and neurologist and both are recommending that he continue the series, as this can happen with the vaccine.
I got a second covid booster on April 19th, 2022, and on May 3 rd, I developed  a skin rash that was diagnosed as dermatographia urticaria. I still have it and I take Zyrtec to alleviate the itching. Could this have been caused by the vaccine booster? And what should I do about the booster coming out in the fall? I cannot connect this condition to any other event or allergies at the time. I thank you.
Developed shingles for the first time just over 2 weeks after my second dose of the vaccine.
It was found pt received a MMR and Varicella vaccine too soon during visit. APRN was notified. Notified Mom and child in the room that pt was given too early MMR and Varicella vaccine. Monitored the patient for 30 minutes after the vaccines and patient did not show any signs or symptoms of side effects. Mom is aware of how to call with questions regarding patient.
Recieved vaccine on Friday 1/8 in AM, by evening had heaviness in shoulders and headache. 1/9 AM moderate fatigue and muscle aches with headache. By 4pm nausea began and temp of 99.4. Severe muscle/joint pain and fatigue progressed from there with temp reaching high of 102.6 before fever broke around 5AM 1/10. Sunday 1/10 - moderate/severe fatigue with low grade temp of 99.6., nausea, headache. Little energy to do anything other than sit on couch. Attempted to go to work Monday 1/11, did have fatigue and headache prior to leaving for work. Once at work developed severe hot/cold flashes on and off with profuse sweating spells anytime I would move around. 1/12 still with headache and nausea.
12/18/20 Covid Pfizer 1/8/21 Covid Pfizer 8/7-8/13 Travel to Montana, family reunion 8/12 + Covid exposure to Sister in law 8/17 ill, tested +Covid, PCR 8/28 potential to RTW
pt recv vax 7JUN95 & 11JUN95 pt devel a rash w/greater than 100 lesions; No further details were providers;
SARS-COV-2 ANTIBODY TEST NEGATIVE; SARS-COV-2 ANTIBODY TEST POSITIVE; This spontaneous report received from a patient concerned a 41 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: non-alcohol user, non smoker, and ventricular hypertrophy, and other pre-existing medical conditions included: The patient did not have drug abuse or illicit drug usage and no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-JUN-2021, Laboratory data included: SARS-CoV-2 IgG antibody test (NR: not provided) 9.77 H. On 13-SEP-2021, Laboratory data included: SARS-CoV-2 IgG antibody test (NR: not provided) Negative, and SARS-CoV-2 IgM antibody test (NR: not provided) Negative. On an unspecified date, the patient experienced sars-cov-2 antibody test negative, and sars-cov-2 antibody test positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sars-cov-2 antibody test negative and sars-cov-2 antibody test positive was not reported. This report was non-serious. This report was associated with product quality complaint: 90000193355. The suspected product quality complaint has been confirmed to be voided (did not meet PQC criteria as this record indicates results to an antibody test for previous covid infection were negative while the antibody test for immunity after vaccination were positive. there is no product quality issue reported as the response to the test for vaccine antibodies is positive.) based on the PQC evaluation/investigation performed. This case, involving the same patient is linked to 20210926264.
Starting on 09/16/2021, had irregular bleeding outside of regular menstrual cycle, lasting for 3 weeks. Went to PC on 10/05/2021. Was referred to urogynocologist. Saw her on 10/27/2021.
Monovalent Covid-19 (Pfizer and Moderna) boosters were administered to 24 patients after FDA removed their authorization; these errors occured from 9/1/22 to 9/7/2022. No more monovalent booster vaccines administeredafter we received the Bivalent Boosters on 9/8/2022. No adverse event noted.
FLUBLOK exposure in pregnant women with no reported adverse event; Initial information regarding an unsolicited valid non-serious case received via nurse practitioner received on 21-Dec-2022. number: 01416768  This case involves an unknown age female patient who was exposed to vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK] in context of flublok exposure in pregnant women with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported FLUBLOK exposure in pregnant women with no reported adverse event occurred at unknown gestation period.   The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, nurse practitioner reported pregnant female patient was exposed to suspect FLUBLOK VACCINE at dose 0.5ml once at (unknown: formulation, strength, lot number, route in unknown administration site) for immunization with no reported adverse event (exposure during pregnancy) (unknown latency). Information regarding batch number requested.  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the event exposure during pregnancy. Additionally, at time of reporting, the outcome of the pregnancy is unknown.
Viral pneumonia; This is a spontaneous report from two contactable consumers received by Pfizer from Merck & Co., Inc. manufacturer control number: 01872889. A male patient of an unspecified age received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, Solution for injection in pre-filled syringe, lot number: not reported), via an unspecified route of administration on an unspecified date as single dose for immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, it was reported that the patient experienced viral pneumonia after vaccination. No further details were provided. The outcome of the event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
fatty tissue built up in deltoid area; Initial information received on 21-Apr-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a male patient age unknown who experienced fatty tissue built up in deltoid area (fat tissue increased), while he received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  In April 2020, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number and expiry date not reported via unknown route in the deltoid nos for prophylactic vaccination.  On an unknown date, the patient developed a non-serious fatty tissue built up in deltoid area (fat tissue increased) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  No laboratories details reported.  Final diagnosis was fat tissue increased.   It was not reported if the patient received a corrective treatment.  The patient outcome was not reported as unknown for fat tissue increased.  There will be no information available on the batch number for this case.
Experienced unusual heart palpitations. Pulse rate and BP normal however. Dr., cardiologist ran EKG, blood tests, and 24 hour Holter monitor. Only thing unusual were PCVS noted on the Holter monitor, 124 PCVS during the 24 hour period. These PCVS have now continued for about a month after the vaccine was administered.