chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no side effects reported; Nurse called stating an expired Merck Sterile Diluent was reconstituted with VARIVAX and administered to a patient on 6/13/2022. No side effects reported. Confirmed with caller that expired diluent has had no temperature excursions. AE filed. No PQC; expired Merck Sterile Diluent was reconstituted with VARIVAX administered to a patient; This spontaneous report was received from a registered nurse and refers to a 34-year-old patient of unknown age. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 13-JUN-2022, the patient was administered an expired dose of sterile diluent (STERILE DILUENT) solution for injection/infusion, lot # S024549, expiration date: 29-MAY-2022, administered once (strength, dose, route of administration, and indication were not provided) reconstituted with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (strength, dose, lot #, expiry date, and route of administration were not provided) administered for prophylaxis (expired product administered, product preparation issue). No side effects reported (no adverse event).
Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild
Localized right arm redness and swelling with some mild to moderate tenderness to palpation. Symptoms began many hours after receiving the vaccine (approximately 14-15 hours after injection).
she heard 2 other people tested positive after receiving the vaccine; she heard 2 other people tested positive after receiving the vaccine; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 2 patients. This is second of two reports.   A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. On an unspecified date, the reporter stated that she heard 2 other people tested positive after receiving the vaccine. The clinical outcome of the event was unknown.    Information about batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021082649 same reporter/drug/event, different patient
Muscle pain, joint pain, chills, headache, nausea, Sharp shooting pain in rt. knee, dizziness
Patient develop redness and swelling in left thigh, measuring 12x11.4cm, and a small area of redness in right thigh, measuring 5.7x2.5cm. Mild tenderness and increased warmth on touch. No fever Patient otherwise normal. Received Benadryl and oral Keflex.
lump under left arm; blood clots during menstrual cycle; late menstrual cycle; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at the age of 41-years-old ), dose 1 via an unspecified route of administration, administered in arm left on 22May2021 09:45 (Batch/Lot Number: EN6208) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included ulcerative colitis from an unknown date and unknown if ongoing. Concomitant medication included ethinylestradiol, norgestimate (TRI-CYCLEN LO) taken for an unspecified indication, start and stop date were not reported. The patient was not pregnant. The patient had no other vaccine in four weeks. The patient had no known allergies. She did not have covid-19 prior vaccination. She had not been tested with covid post vaccination. The patient experienced lump under left arm, blood clots during menstrual, and cycle late menstrual cycle on 24May2021 with outcome of not recovered. The patient received no treatment for the events. The second dose of the vaccine was given on 12Jun2021 (lot number: ER8730).  Follow-up attempts are completed. No further information is expected.
Started having a disturbance with hearing, blurred vision, hands became cold, diaphoreses, and pallor.  Bp 92/68, HR 95, pulse ox 92
arm pain, chest pain,lethargy, headache, swollen lymph glands, throat pain  Narrative: Employee states: day 1: felt injection and symptoms immediately  following in arm and left part of chest. Within the first hour, got very tired and  could not work. A few hours later a headache persisted and lasted through  thenight. day 2: still had headache but it became less persistant over time- would  come and go throughout the day. Continued to fall asleep (at least 5 times) and  difficulty staying awake. Some stabbing pains in the throat area. day 3: awoke  with left underarm pain. Lymph glands are now swollen. two episodes of stabbing  pain in my throat today.
Information has been received from a consumer, a 35 year old female with no known allergies and a history of sinus disorder and recurrent sinusitis, who on 6/25/04 was vaccinated SC in the left upper arm with a second dose of varicella virus vaccine live (lot # 645288/0689N). There was no concomitant medication. After two weeks (approximately 7/9/04), the patient developed swollen glands on both sides of her neck. All testing, a CT scan and blood work was normal. The patient's swollen glands on both sides of her neck did not improve. The patient is not recovered. There was no product quality complaint reported. Follow up information was received from a physician who reported that the patient has had intermittent sinus problems since spring, approximately 10-14 days (approximately 7/5/04) after receiving the varicella virus vaccine live. The glands in her neck area became very swollen and she went to her ENT physician who found no reason for the swelling. The ENT physician suggested that the patient contact the company to see if this could be a reaction to the vaccine. During this period of time the patient had a throat culture which was negative and she never received any antibiotics during this time. It was noted that the patient currently feels well but states that her gland might still be slightly swollen, but she isn't sure. Additional information received from a physician reported that the patient recovered on an unknown date. The patient was not ill at the time of vaccination and she did not have any relevant laboratory tests completed. The patient sought unspecified medical attention. No further information is expected.
Medical Assistant administered, in error, an "injectable" flu vaccine "intra-nasally". The precipating events are as follows:  1) On 10/23 at 0615a, vaccines were incorrectly dispensed by Pharmacist; specifically, the correct 500 doses of injectable vaccine was correct but the 60 doses of "Fluarix" was incorrect (correct vaccine is "FluMist". 2)MA administered the vaccine intranasally after she questioned it looked different but there was a plastic valve that somewhat mirrored the one on the FluMist.   3) Patient described the feeling of fluid down her throat.   4)MA had just prevsious given one dose incorrectly to another patient and then states she examined the insert after and further questioned the vaccine administration but did not immediately recognize it was IM administration.   5) MA did showed injectable syringe to writer (RN) who was giving other vaccines and TB tests. It was after that the MA reviewed the packaging again and found this to be the injectable flu vaccine incorrectly dispensed by pharmacy and undetected by HS.  Potential Injury: Pharmacy contacted the manufacturer's rep and confirmed there are no adverse reactions due to the injectable form of vaccine being administered/absorped into the nasal mucosa; no mild irration was noted by patient when contacted several hours later; no benefit of immunity is obtained by this method. Readministration of injectable or intranasally was recommended.   Additional Comments: 1) Pharmacy notified of error in dispensing of vaccine in order to determine process defects or procedural concerns. 2) Medical Assistants not considered qualified to make medical/clinical decisions that require judgement. MA did question the unusually container after the employee/patient commented after the the medical was administration, she did review the insert (per patient) and mentioned to writer that it looked different.  3) The RNs responsible for ensuring the vaccine is correct; both RN and writer (RN) take some responsibility for not reading carefully the product packaging and/or insert. RN at the time of pick up from Pharmacy and writer after incorrect administration.  4) Further clinical judgement by MA and RN before or after 1st incident would have prevented this one. 5) VAERS report will be completed
Chills, feverish, muscle aches, headache, severe fatigue, vomiting (couldn't keep down water or sports drink the first day) No appetite, sore arm
BODY ACHES; CHILLS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 31-OCT-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 31-OCT-2021, the patient experienced body aches, and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, and body aches. This report was non-serious.
Patient was staring off at Skilled Nursing Facility, patient then had a seizure in ER - requiring intubated for respiratory distress.  Patient's cause of seizure is of unclear etiology per Neuro Critical Care Physician Note.  MRI pending, patient still intubated, not following commands and not answering orientation questions despite being all small dose of sedation for agitation.
Information has been received from a physician concerning a 17 year old female who on 11-FEB-1994 was vaccinated with the first dose of MMR II (lot number not reported) (HSA) and on 02-APR-1997 was vaccinated with the second dose of MMR II (HSA) (lot numbers not reported). On 17-NOV-2009, lab data revealed that IgM negative, IgG 5.88 and serum amylase 97. On the same date, the patient was diagnosed with mumps. The patient was afebrile. The patient had left parotitis. The onset date of mumps was reported as 30-NOV-2009. At the time of the report, the patient's outcome was unknown. Follow-up information was received which reported that the patient on 10-NOV-2009 experienced onset of symptoms. On 11-NOV-2009, the patient was diagnosed with mumps. On 11-NOV-2009, laboratory data revealed that IgM negative, IgG 5.16 and serum amylase 61. The patient was afebrile and had parotitis. At the time of the report, the patient's status was unknown. No further information is available.
she is still experiencing fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician) from medical information team. The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and administration date 26Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Family history included: "allergic to sulfa" (unspecified if ongoing); "Lyme's disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "not recovered", described as "she is still experiencing fatigue".  Additional information: The patient stated that she received both doses of the vaccine, the last one was on 26Feb2021 and patient reported that she was still experiencing fatigue. She asked if that was something we have heard of. She had an appointment with the doctor on Tuesday.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
vasal vega, shivers, achy, fatigue, soreness in arm, naseau,
Approximately 5 hours after injection, I started to feel chilled and began shaking and shivering. No fever. Felt general malaise. No appetite. Developed bad headache which prevented sleeping. The next day, it seemed this was over, but still had no appetite and in the evening the shaking and shivering resumed. Developed another bad headache that prevented sleeping again. Next morning  (today) still no appetite and continued to feel cold. Have eaten some even with no appetite, so I could take ibuprofen which seemed to help a bit.
Erythema Induration 4+3/4 inches x 5+3/4 inches with bruising left deltoid
Tested positive on rapid test for covid after bivalent booster; Tested positive on rapid test for covid after bivalent booster; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Tested positive on rapid test for covid after bivalent booster". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Nightmares,  103 degree fever,  pain in joints and whole body, severe headache
56 y.o. female with known history of depression and essential hypertension who presents with chest tightness and pain with swelling to left upper arm. Patient states she received her 2nd Maderna Covid vaccination on Friday, had been feeling well up until that point. Later that evening, developed fever, body aches and chills and soreness to her left upper arm. Saturday had fevers T-max 102.3 with continued body aches and chills, pain increased to her left upper arm. Today, woke with spreading erythema, warmth and tenderness to her left upper arm with swelling and developed left-sided chest tightness with pain. Patient states she also had sore throat with swallow, flushing sensation to her upper chest, swelling sensation to left side of her neck and also continued with fever of 101. The patient denies any nausea, vomiting, drooling, inability to control secretions, diarrhea, abdominal pain, pruritus, wheezing. Patient states she received her 2nd Maderna Covid vaccination on Friday, had been feeling well up until that point. Later that evening, developed fever, body aches and chills and soreness to her left upper arm. Saturday had fevers T-max 102.3 with continued body aches and chills, pain increased to her left upper arm.
In August of 2021, patient suffered a cardiac arrest. Patient was taken to the hospital and placed on blood thinners for blood clots, stent was placed in and a "balloon" to pump the heart. White blood cell count down and blood cancer found. Patient's condition appeared to be improving after a week in the ICU but was still in a coma. Patient needed to be removed from several medications including blood thinners in order to remove organ assisted machines. When this took place he went into cardiac arrest again and his conditioned deteriorated worse than before. At this time a family decision was made to not resuscitate patient per his wishes.
Engerix-B pediatric dose administered to an adult; Engerix-B pediatric dose administered to an adult; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 51-year-old female patient who received HBV (Engerix B pediatric) (batch number P49X7, expiry date 07-DEC-2023) for prophylaxis.   On 17-JUN-2023, the patient received the 3rd dose of Engerix B pediatric. On 17-JUN-2023, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: Engerix-B pediatric dose administered to an adult) and adult use of a child product (Verbatim: Engerix-B pediatric dose administered to an adult). The outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK receipt date: 22-Jun-2023 The reporter consented to follow-up via email. An adult patient received third dose of Engerix-B by error, which led to underdose and adult use of a child product.
Mother called to describe onset of itchy welts/hives on ears, arms and trunk emerging~ 2.5-3 hours after administration of vaccine.  No breathing difficulties or facial/lip swelling.  She treated with oral diphenhydramine which caused transient improvement in pruritis and rash for a few hours, but rash re-emerged in different areas on her trunk and arms after a few hours.
Initial information received on 20-Nov-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a five-months old female patient who was vaccinated with a dose of PENTACEL lot UI952AAA in the left thigh on an unknown date. The patient's past vaccination(s) included PREVNAR on 22-AUG-2018 with at 2 months, ROTAVIRUS VACCINE on 22-AUG-2018 with at 2 months, HEPATITIS B VACCINE on 22-AUG-2018 with at 2 months, PENTACEL on 22-AUG-2018 with at 2 months, HIB on 24-OCT-2018 with at 4 months old and Ipol on 24-OCT-2018 with at 4 months old. The patient's past medical history, medical treatment(s) and family history were not provided. It was a case of actual medication error due to wrong vaccine administered. No reported side effects. 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 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 party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none
Multivessel CAD-s/p CABG x5. Hospital admission within 6 weeks of receiving the COVID vaccine.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Feb2022 as dose 4 (booster), single (Lot number: FJ5683) at the age of 32 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "multiple sclerosis." (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: With two test, I was once again positive; (2022) Negative, notes: having two negative test I felt tired again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: The patient received Anti-viral therapy of Paxlovid from 07Jul2022 to 11Jul2022 for the treatment of COVID-19. No other medication received in 2weeks.
both arms are numb - feels like they have gone to sleep; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (both arms are numb - feels like they have gone to sleep) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concomitant products included INSULIN DETEMIR (LEVEMIR), INSULIN ASPART (NOVOLOG), RAMIPRIL, CARVEDILOL, CELECOXIB (CELEBREX), ESTROGENS CONJUGATED (PREMARIN), AMITRIPTYLINE, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), POTASSIUM CHLORIDE, ACETYLSALICYLIC ACID (BABY ASPIRIN), LEVOTHYROXINE SODIUM (SYNTHROID), DULOXETINE HYDROCHLORIDE (CYMBALTA), ATORVASTATIN CALCIUM (LIPITOR), DICYCLOMINE HCL, HYDROCHLOROTHIAZIDE, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and METFORMIN for an unknown indication.   On 23-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) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced HYPOAESTHESIA (both arms are numb - feels like they have gone to sleep). At the time of the report, HYPOAESTHESIA (both arms are numb - feels like they have gone to sleep) outcome was unknown. Possible          No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not Applicable.
MOM CALLED TODAY STATING THAT SHE CALLED LAST FRIDAY 4/8/05 WITH CONCERN OF 6 PIMPLES ON BACK.  TODAY SHE CALLED STATING HE HAS THE CHICKEN POX BECAUSE HUSBAND JUST HAD SHINGLES AND NOW HE HAS 30 BUMPS. HE HAD THE VARICELLA VACCINE ON 10/09/03. MOM REFUSING TO BRING PATIENT IN FOR PROPER DOCUMENTATION.  NO ACTION/TREATMENT TAKEN.
day 1, sore arm.  day 2 - 9 am - vomiting, nausea, major pain in lower back, headache,  unable to eat or drink, started feeling better about 4pm, stayed in bed until 8 pm.,sore arm.  contacted medical office, nurse said if I could go to Urgent Care if needed. day 3 - sore arm, all symptoms are gone.
Narrative: 79 yo patient with history of stroke, hypertension, prostate cancer. Hospitalized for acute CVA on 3/2 after receiving first dose of Pfizer vaccine on 2/27.