chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021 at 2:43 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 30-Mar-2021 at 2:48 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 65.63 for dose administered on 02-MAR-2021 and 65.71 for dose administered on 30 -MAR-2021   No concomitant medications were reported.  Batch number 014M20A underwent temperature excursion 02-MAR-2021 with temperature 27 degrees Fahrenheit at 09:00 AM, 29 degrees Fahrenheit at 10:00 AM, 32 degrees Fahrenheit at 11:00 AM, 33 degrees Fahrenheit at 12:00 PM, 35 degrees Fahrenheit at 2:00 PM, 36 degrees Fahrenheit at 3:00 PM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 02-MAR-2021. Batch number 019B21A underwent temperature excursion on 30 -MAR-2021 with temperature 33 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge on 23-MAR-2022 and beyond use date for the vial was reported as 22-APR -2021. Product moved to clinic on 30-MAR-2021  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.
Client observed another client having an adverse reaction and became anxious. VS 130/90-88-16 .  Color pale, diaphoretic and appears anxious.  Juice given.  Breathing exercises started.  Calmed down after a few minutes.  Refused any further treatment.  Released to home.
Very Large oval red circle at exact area where flu vaccine was administered. Ask for size. Dr. Warm to touch, was sore only for a day. Not sore as of now.
Red sunburn like rash on chest & neck causing itching started 3 days ago (12-10/12) rash is localized does not seem to be spreading. Patient using ALEVE 220mg twice daily.
Swelling of axillary lymph node; pain at injection site; extreme fatigue, body aches, fever and headache that has kept me from working..
Bruising. Petechiae - had blood test 3/25/21 - sent to ER low platelets; Also had high BP. Given platelets, admitted 3/26/21, given steroids and BP meds. D/c'd 3/28/21. Dx: ITP. Given 4 day dose of Dexamethasone. Platelets increased. 1 week later platelets dropped. By 4/15/19, they dropped some more and seem to have leveled out (4/19/21), but still testing weekly. ANA blood work positive, but no other symptoms to fit most common autoimmune diseases. Saw rheumatologist today for more blood work.
This spontaneous report as received from a Medical Assistant via Company Representative refers to a female patient of unknown age. The patient's pertinent medical history, drug reactions or allergies were not reported. On 07-FEB-2017, the patient was vaccinated with ROTATEQ orally as prophylaxis (lot number and expiration date were not reported). On an unspecified date in 2017, the patient developed bloody mucous in her stool. The patient sought medical attention. It was unknown if the treatment was given. The outcome of the event was not reported. No product quality complaint was involved in this case. No further information was available. The causality between the event and ROTATEQ was not reported.  Upon internal review, the event was considered to be medically significant. Additional information has been requested.
Hypertensive Crisis, chest pain, facial flushing which is still occuring. Went to ER at 12:15 am on 3/17/2021.  Treated with Labetatol.
My daughter had been suffering from extreme full body Uticaria for three years and had been treated with benadryl, allergy medications, hydrocortisone creams and occasionally would be put on prednisone med pacs to control the uticaria. Two or Three weeks after her second vaccine of gardisil she noticed a lump on her neck. I took her to her pediatrician and was prescibed an antibiotic for possible glndular infection. After the course of the antibiotics were finished she came to me about 20 days later and said the lump never went away and now it was bigger. I immediately went back to my pediatricians office the next day. He sent her for an iimmediate cat scan. The cat scan results were enlarged lymph glands in her head neck and chest.We rushed her to the hospital rigth from his office where she was admitted. A biopsy was performed and she was diganosed with lymphoma cancer stage two.(Hodgkins) I am sure that this was caused by the gardisil vaccine.  8/25/09-record received for DOS 5/12/06-for allergy specialist visit for C/O difficulty controlling hives present since 9/05. Impression: idopathic urticaria.   8/24/09 PCP and oncology medical records received DOS 4/15/08 to 5/15/09. Assessment: Hodgkin Lymphoma Nodular Sclerosing Type, Stage IIAd. Patient presents with painful burning rash on extremities. Urticaria, obesity, polydipsia. Hypertension. Ear pain. Cervical lymphadenitis. Chemotherapy and radiation. Pain neck and back - resolving radiation reactions.
Pt had recently turned 12, but was mistakenly administered by the RN his second  dose of pfizer as a 5-11 year dose instead of a 12 and up dose.  No adverse effects were seen.  Based on CDC guidelines, he is considered vaccinated and no repeat dose was necessary.  Parent was informed.
11:30 nausea and vomiting.  11:35 symptoms resolved.  BP 111/68, HR 83, sats 99, Resp 18.  11:57 left ambulating for home accompanied by family.
Mild eye irritation for the last week, floaters beginning around 07.33.2021, and increasing until today (07.26.2021) on set of very large floaters and strands across field of vision, the smaller, but constant floaters. 2 very brief times of irregular heartbeats in the last week
Information has been received from a physician concerning an 8 month old female  who on 10/28/99 was vaccinated with a 3rd dose of Hepatitis B vaccine recombinant. On 10/28/99, the patient developed wheezing and a "croup-like" illness. Subsequently, the patient recovered. Additionally subsequent to this event. It was noted that the patient also experienced a similar reaction after vaccination with Varicella Virus vaccine live on 05/11/00. Additional information has been requested.
patient experience some raise rash like localized to the right arm were injection was given 2 days after injection. heat would increase the itcheness
On 12/24/2020 in the morning I noticed it was red and swollen at the injection site, tender to the touch, it was extended approximately 3in to the injection site. Telehealth visit with doctor on 12/24/2020.
A 12 year old female patient received first dose of GARDASIL 9 6 months to a year ago; The patient is not experiencing any side effects.; Was brought in for her second dose by one parent but 10 days later, the other parent brought her into the HCP's office and the second dose was administered again; This spontaneous report was received from a health professional via company representative, concerning a 12 year old female patient. There was no information about the patient's medical history, concurrent conditions, concomitant medications or drug reactions/allergies.  In approximately 2019, (reported as "6 months to a year ago"), the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). On 18-AUG-2020, the patient was brought to get her second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), but 10 days later (also reported as 28-AUG-2020), the other parent brought the patient into the health care professional's office and the second dose was administered again. All vaccinations for prophylaxis (dose, frequency, route of administration, anatomical location, lot number and expiration date were not provided for none of the vaccinations).  At the reporting time, the patient was not experiencing any side effects.
chest tightness and tachycardia after first dose; chest tightness and tachycardia after first dose; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "ventricular tachycardia" (unspecified if ongoing), notes: history of ventricular tachycardia. The patient's concomitant medications were not reported. The following information was reported: CHEST DISCOMFORT (non-serious), TACHYCARDIA (non-serious), outcome "unknown" and all described as "chest tightness and tachycardia after first dose". Therapeutic measures were taken as a result of chest discomfort, tachycardia.  Additional information: Middle aged white female experienced chest tightness and tachycardia after first dose of vaccine. After the event shortly following the first dose of vaccine, she took her medicine and stabilized.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
pt had a positive COVID test on 9/8/21 ordered from nursing home; pt passed away at hospice facility; DC and med records sent to info@vaers.org
Patient presents with "hot flash" feeling and a little bit dizzy.   Alert & oriented. Insulin dependent diabetic - did not take insulin this AM.   She did not think this was hypoglycemia. Vital signs stable throughout observation period. Initial BP - 135/87,  Pulse - 94, O2 sat - 99%. All symptoms were self-resolving with time. Not orthostatic and ambulated s problem before discharge
patient received the first vaccine at the end of December and never received the second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received the first vaccine at the end of December and never received the second dose) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2020, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received the first vaccine at the end of December and never received the second dose). In December 2020, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received the first vaccine at the end of December and never received the second dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided. Treatment information was not provided.
Reports arm started to ache the day after.  It has remained sore and has affected mobility.
The day I received vaccine I felt fine that evening exp chills. On Fri I woke up with really bad headache lasted all day took prescription. Then on Saturday my head felt bruise from the headache the day before.
No reacton at time of shot. Next day had hives/rash across body, torso arms and back. Still have same symptoms 48hr later
doses administered past the published expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED. On 11-Oct-2021, EXPIRED PRODUCT ADMINISTERED had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Vaccine removed from freezer 8:00 am on 11-OCT-2021.  No concomitant and treatment medication reported   This case was linked to MOD-2021-364617 (Patient Link).
vaccine was injected in the fatty tissue on the posterior of the arm instead of deltoid, no AE; Initial information received on 16-Sep-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves female patient (unknown age) who was vaccinated with INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE QUADRIVALENT MULTIDOSE] (0.5 (unspecified), injection, lot number and expiration date not reported) via unknown route of administration  in the fatty tissue on the posterior of the arm instead of deltoid as prophylactic vaccination on 16-Sep-2020 (PT:product administered at inappropriate site).  The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to vaccine administered at inappropriate site (same day latency).  No adverse event reported at the time of reporting.  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 interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information on the batch number for this case.
Case number PHEH2015US019308 is an initial spontaneous report received from a pharmacist on 28 Sep 2015. This report refers to a female patient whose age was not reported. Past medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on 27 Sep 2015. It was reported that the vaccine administered had a temperature excursion of 47 degree Fahrenheit for 2 hours. No adverse events were reporting following the maladministration.
At day 14, small pustule on erythematous base on hands, forearm, elbow.
Day 2 awoke with 2.5 inch induration at injection site. Soreness. Day 3 developed multiple itchy bite-like lesions on left forearm with one small linear area; itchy but no vesicles; few on right forearm. Day 4 developed one lesion on forehead. Day 5 all areas fading. Other than itching, no other symptoms.  Able to work and perform usual ADLs.
Information has been received from a nurse practitioner concerning a pt who in 1996 was vaccinated with a dose of varicella virus vaccine live (lot number 620620/1107D). Subsequently, the child developed over 200 lesions. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested. This is in follow up to report previously submitted on 05/14/2004 information has been received from a nurse practitioner concerning an 8 year old patient with no allergies and no relevant medical history who on 11/25/1996 was vaccinated subcutaneously with a firse dose of varicella virus vaccine live (lot # 620620/1107D). Concomitant medication included amphetamine asparate (-) amphetamine sulfate (+) dextroamphetamine saccharate (+) dextroamphetamine sulfate (Adderall). There was no illness at the time of vaccination. On Mar 12 2004, the patient developed varicella (previously reported as child developed over 200 lesions). It was noted on physicial exam that the patient was alert and cooperative, temperature was 96.4, his skin had erythematous clear filled vesicles on the face and abdomen, ENT was clear, lungs were clear and abdomen was soft. It was also noted theat the child was exposed to chickenpox in school on 3/02/2004. The treatment plan included acyclovir 600 mg QID x 5 days, avenno bath and diphenhydramine HCL (Benadryl) as needed. There were no other lab diagnostic tests performed. Unspecified medical attention was sought. There was no product quality complaint involved. Subsequently, the patient recovered on 03/17/2004. No further information has been requested.
Initial information received on 20-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 60 years old male patient who received a dose of vaccine FLUZONE HIGH DOSE (lot UI981AA and expiration date 16-Mar-2019) via unknown route in the right arm on 19-Nov-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant vaccine included PNEUMOVAX for Immunization. It was a case of actual medication error due to inappropriate age at vaccine administration and accidental overdose. It was not reported if patient had any adverse event. 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. List of documents held by sender: none.
Presented w/ weakness, lack of appetite, diarrhea. Covid+, pneumonia. Tx w/ O2.
problem with sleeping; has this bad muscle issue in the back, muscle is tight; horrible stretches; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (problem with sleeping), MUSCLE TIGHTNESS (has this bad muscle issue in the back, muscle is tight) and MUSCLE SPASMS (horrible stretches) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No reported medical history.  Concomitant products included NAPROXEN, LOSARTAN and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced INSOMNIA (problem with sleeping), MUSCLE TIGHTNESS (has this bad muscle issue in the back, muscle is tight) and MUSCLE SPASMS (horrible stretches). At the time of the report, INSOMNIA (problem with sleeping), MUSCLE TIGHTNESS (has this bad muscle issue in the back, muscle is tight) and MUSCLE SPASMS (horrible stretches) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included unspecified steroid topical cream. The patient had problem sleeping and all of sudden she was wide awake, she slept for 2 hours a most. The patient had see her chiropractor for muscle issue and horrible stretches and was told that her muscle was tight.  Concomitant medications included Steriod Topical Cream  No treatment information was reported.
Fever; Headache; This is a spontaneous report from a contactable consumer (patient).  A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number and expiration date unknown), via an unspecified route of administration on an unspecified date in Jan2021 (on Friday) at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient developed a headache and fever afterward that she was still somewhat experiencing. Currently taking Tylenol for the events. The outcome of the events was not recovered.  Information on the Lot/Batch Number has been requested.
Jynneos vaccine administrated via intramuscular route; Case reference number US-BN-2022-001848 is a spontaneous case report initially received on 10-Aug-2022 from a consumer via Bavarian Nordic and concerns a patient of unknown age and gender.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient was vaccinated with Jynneos vaccine (smallpox and monkeypox vaccine, live, nonreplicating; batch number: unknown) at an unknown dose, administered intramuscularly, for unknown indication (explicitly coded as 'inappropriate route of vaccination').  At the time of this report, it was unknown if the patient experienced any adverse events.  Additional information received from Bavarian Nordic on 12-Aug-2022 included the updated local case ID.  Additional information received from the reporter on 25-Aug-2022 included confirmation of the country of occurrence.; Reporter's Comments: A patient of unknown age and gender was vaccinated with Jynneos vaccine, at an unknown dose, administered intramuscularly, for unknown indication which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse events. Causal relationship is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A patient of unknown age and gender was vaccinated with Jynneos vaccine, at an unknown dose, administered intramuscularly, for unknown indication which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company. At this point, it was unknown if the patient experienced any adverse events. Causal relationship is assessed as not related to suspect product but to human factor. The case is non-serious.
pt recvd vax & had a syncopal or vasovagal episdoe; pt recovered w/o any residual effects; No further details were provided;
Patient states vaccine was placed too high in arm causing extreme shoulder pain resulting her seeing a Dr. for treatment.
pt had a vasovagal episode a few minutes after receiving the flu vaccine. He fainted and was placed on floor with legs elevated for several minutes. He returned to consciousness and was seated resting for several more minutes before leaving clinic with mom.  Mother has history of vasovagal fainting but this is the first time for the patient.