chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pressure on chest; Hard time breathing/ got winded even talking; Heart beating weird + fast; heart felt like it was palpitating; This is a spontaneous report from a contactable other healthcare professional (medical assistant). This other healthcare professional reported similar events for two patients. This is the second of two reports.  A 15-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (lot number and expiry date: unknown) as dose number unknown, single for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On unspecified date, the patient experienced pressure on chest, hard time breathing/got winded even talking, heart beating weird + fast, and heart felt like it was palpitating. The events were considered serious, medically significant. Outcome of the events was unknown.  Information on lot/batch number has been requested.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202100956501 same reporter, drug and events/ different patient
Booster dose given to a 17 year old; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Booster dose given to a 17 year old) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer vaccine (1st and 2nd doses were Pfizer vaccines). Past adverse reactions to the above products included No adverse event with Pfizer vaccine.    On 30-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Nov-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Booster dose given to a 17 year old). On 30-Nov-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Booster dose given to a 17 year old) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient stayed for 15 minutes after the administration of vaccine and did not show any signs and symptoms. No medical history was provided by the reporter. No concomitant medication were given. No treatment information were given.
Initial unsolicited report received from a physician on 27 August 2015. This case involves a female patient (age not reported) who was vaccinated with a dose of Influenza vaccine and Pneumococcal vaccine (batch number, dose, route and site of administration was not reported for both vaccines) on an unspecified date. Patient's medical history was not reported and concomitant medications was reported as SYSTANE. On an unspecified date, following the vaccination, the patient experienced arthritis type pain. Lab data and corrective treatments were not reported. Outcome of event was unknown. List of documents held by sender: none.
Client received flu shot in Health Unit 10/9/18 approximately 1230 PM. Client chose to not stay in health unit for 15 min post flu vaccine administration. Client reports going to ER 10/9/18 approximately 6 PM for shaking, fever, and chills. She reports taking a TYLENOL before going to ER. Client reports her temperature and VS were normal. Client reports all tests, bloodwork, including flu test and pregnancy were all negative. Client reports being administered NS and no other medications or treatments. Client reports staying in ER for only 4 hours and reports the shaking stopped post NS administration. Client reports ER had no diagnosis or discharge instructions. Client reports ER does not think reaction is from Flu shot. Client reports feeling achy and feverish yesterday, 10/10/18, and stayed home. Client reports feeling better today, 10/11/18, but started to feel achy, feverish again and requested temperature check. Temperature and VS normal. No other complaints or signs/symptoms. Denies new meds, diet, or changes in appetite/BMs. Client reports feeling stressed at work recently and also admits not hydrating well enough. Client recommended to rest, hydrate with 2 L of water throughout day, and to report to MD if signs/symptoms worsen. Client was in stable condition in health unit, no signs or symptoms of distress, and no abnormal assessment with left deltoid (where Flu shot administered) except for minor but improved tenderness upon palpation.
patient was administered a first dose COVID Vaccine that had been at room temperature for 21 hours. Per Pfizer stability excursion data, administration may be supported for up to 24 hours dependent on microbiological risk
This spontaneous report was received from a pharmacist, concerning a patient of an unknown age and gender. The patient's medical history, concurrent conditions, drug reactions or allergies were not reported. On 03-APR-2017, the patient was inadvertently administered a dose of ZOSTAVAX lot # L044529 which expired on 09-FEB-2017 (strength, dose, route of administration or anatomical location were not provided), for prophylaxis. The vaccine was reconstituted in a properly stored sterile water diluent (manufacturer unknown). No adverse effects were reported. No further information was provided. No product quality complaint (PQC) was involved. Additional information has been requested.
I got up in the middle of the night  on 12/10 to use the bathroom and came to on the floor shortly after 2am. I don't know how long I was out because I don't remember getting up at that time but do remember getting up about 1:30 am. I tried to get up from the floor but was unable to. Finally after 4:00 I called 911 who came and got me up.  Because I tested well they allowed me to go back to bed.  On Thursday 12/09 I went to bed early because I was freezing and felt flu-like. This was after I searched the bathroom cupboard for a thermometer and was able to get up on my own.
Information has been received from a healthcare worker referring to multiple unspecified patients of unknown demographics. There was no medical history or drug reaction/allergies reported. On unknown date, dose of improperly stored VARIVAX (lot# K006138 with expired date 29-APR-2016, lot# K003413 with expired date 06-MAR-2016, lot# L002870 with expired date 27-JAN-2017, lot# L000456 with expired date 06-JAN-2017, lot# L010145 with expired date 24-MAR-2017, lot# L012036 with expired date 07-APR-2017, lot# K006133 with expired date 29-APR-2016; dose and route were unknown) might have been administered to the patients. No concomitant medication was provided. No adverse experiences were reported. This is one of two reports received from the same reporter (1508USA005691). Additional information has been requested.
Information was received on 25-AUG-2017 from a field representative reporting for a physician regarding a 14-year-old female with no known medical history and no concomitant medications who received a dose of GARDASIL 9 (Lot# M014929, exp. 27-MAY-2017) on 23-AUG-2016 and a second dose of GARDASIL 9, (Lot# M016193, exp. 24-APR-2018) on 10-OCT-2016 for prophylaxis. It was reported that a few days after the second dose the patient reported "breaking out in hives on her arms and belly." No treatment was provided. The patient recovered from this event. The patient no longer has the hives. Additional information has been requested.
The patient was observed for the required time and then released from the clinic. While driving home, she felt very tachycardic. She assessed her pulse as being 165 and returned to the vaccination clinic. By the time she returned, she felt dizzy and nauseated. Medical command was contacted who advised for paramedics on site to administer 50 mg of Benadryl IV as well as 4 mg of Zofran and an IV fluid bolus. Those treatments were executed, the tachycardia resolved and the patient felt better. She was transported to the Hospital for further evaluation and treatment as a precaution.
adcel given intradermally instead of intramuscular, with no reported adverse event; Initial information received on 06-Sep-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 43 years old female patient to whom diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] was given intradermally instead of intramuscular with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received 0.5ml once (1X) as  booster dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine, suspension for injection (lot C5963AA; expiry date: 18-Jan-2024) via intradermal route in the left forearm for immunization instead of intramuscular, with no reported adverse event (incorrect route of product administration) (unknown latency).  Action taken : not applicable.  Outcome : Unknown.   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 guidelines. 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.
Paleness, dizziness, feeling of being overheated (did not take temperature, so possibly not a fever), vomiting.
pt recv vax 10JUN97 & 18JUN97 pt devel greater than 50 lesions all over body;pt presented to MD:
This spontaneous report as received from a consumer, as part of a marketing research program, refers to herself, a 54 year old female patient. The patient's concurrent conditions included high blood pressure, hypertension and diabetes. The patient's medical history was not reported. On 04-NOV-2015, the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot number and expiration date were not reported). Concomitant therapy was not reported. On 04-NOV-2015, the patient experienced high blood pressure and was hospitalized. The outcome of the event was reported as recovering/resolving. The reporter considered the event to be not related to ZOSTAVAX. Additional information has been requested.
hives all from her head down,hives started to come back again after treatment; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives all from her head down,hives started to come back again after treatment) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced URTICARIA (hives all from her head down,hives started to come back again after treatment). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, URTICARIA (hives all from her head down,hives started to come back again after treatment) outcome was unknown.            Concomitant medication included Bbrth control pills and treatment medication also included Steroid shot.   This case was linked to MOD-2022-459639, MOD-2022-459618 (Patient Link).
"burning sensation that lasted on & off about 2 weeks"; "trouble breathing for a day"; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION ("burning sensation that lasted on & off about 2 weeks") and DYSPNOEA ("trouble breathing for a day") in a female patient of an unknown age 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. On an unknown date, the patient experienced BURNING SENSATION ("burning sensation that lasted on & off about 2 weeks") and DYSPNOEA ("trouble breathing for a day"). At the time of the report, BURNING SENSATION ("burning sensation that lasted on & off about 2 weeks") and DYSPNOEA ("trouble breathing for a day") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medications reported was not provided.  No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
I have had 4 severe migraine headaches with vomiting since getting my first Covid vaccine. Two of the four required trips to urgent care for IV treatments. I had not had 4 migraines total in the 25 years prior to getting the vaccine.
suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient had been plagued with scalp shingles for almost 3 months. The patient stated that, false advertising that said, the Shingles vaccine prevented shingles. It did not. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
Pt recvd vax & exp a local rxn of redness, warm to touch, painful area @ site of inject (rt deltoid);
Developed Guillain-Barre Syndrome. Was hospitalized for one week and underwent IVIG, then transferred to a rehabilitation center for four weeks to undergo rehab and caretaking. Is recently home after five weeks and is learning how to adapt at home with her limited walking ability.
Given 10 mcg of Moderna Bivalent instead of the recommended 25 mcg
31OCT97 pt exp pain in lt arm & shoulder;pain cont & blister appeared on arm away from inj site;PA did state inj should have been given further back on arm in a more fatty part of muscle;
Muscle or body aches, Severe neck pain which caused extreme impairment and difficulty with any type of movement.
This medically confirmed literature report (initial receipt 28-Apr-2015) concerns a 73 year-old male patient who had a past medical history of lymphoma and prostate cancer. On an unspecified date, the patient received Influenza virus vaccine (manufacturer and batch number not provided). On an unspecified date, one month after the vaccination, the patient was brought to the Emergency Department, and subsequently hospitalised, with a change in mental status and fall. He reported having a fever, muscle ache, sore throat and fatigue for the 1 day. His temperature was 99.5 F and the rest of the physical examination was unremarkable. The laboratory data demonstrated normal BMP (basic metabolic panel), mild elevation in WBC (white blood count), elevation of liver enzymes (AST 300, ALT 100). Creatinine kinase was 3000 and continued to rise to as high as 12000 which was thought to be out of proportion to the duration of fall (30 minutes), Influenza A subtype H3 was positive, Mycoplasma IgM antibody was positive, and PCR (Polymerase Chain Reaction) was negative. His EEG (electroechocardiogram), chest radiograph were unremarkable. He had aggressive intravenous fluids and was treated with azithromycin and oseltamivir. His renal function remained stable and patient improved remarkably within 3 days. His creatinine kinase did trend down. The outcome was not reported (recovered for fever, muscle aches, sore throat and fatigue). Reporter comments: 48% of the influenza A (H3N2) viruses collected and analyzed from October 1 through November 22, 2014 were antigenically 'like' the 2014-2015 influenza A (H3N2) vaccine component, but that 52% were antigenically different (drifted) from the H3N2 vaccine virus. Decreased vaccine effectiveness has been observed with antigenic drift in past seasons. Vaccine effectiveness in patients over 65 years of age is with time, in preventing laboratory-confirmed influenza infection was 61 percent (95% CI 5 to 84 percent) during the first 100 days after vaccination. Influenza vaccine prevents the severity of illness in patients over 65 years of age.
PALATAL ITCHING AND LINGUAL PARESTHESIAS WITHIN 1 HOUR OF VACCINE; DIPHENHYDRAMINE 25MG ORALLY WAS GIVEN, PATIENT RESPONDED TO ANTIHISTAMINE
Two hours after administration of the shot, patient called the pharmacy and explained that she was feeling hot/burning sensation running along her neck on the side the shot was administered.  Patient did not report any other side effect (swelling, pain, fever, etc), but asked that this side effect be reported as she was speaking to a gentlemen who had experienced the same from getting a high dose shot from another facility.
Eye twitch - left eye - occurred a few days after the first shot - has not resolved. Occurs approx 20 x per hour
This spontaneous report was received from a nurse refers to an unspecified number of patients of unknown age and gender. No concurrent condition or medical history was reported. On an unknown date the patient was vaccinated with improperly stored (29.6 F for 26 hours), Oral, ROTATEQ (lot # L008996, Exp. 01-DEC-2016, dose and route of administration was not provided). No concomitant therapy was reported. There was no previous temperature excursion. No adverse symptoms were reported. The outcome of the event was unknown. No product quality issue was involved. This is one of the several reports from the same reporter link. Additional information has been requested.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 at 10:00 as dose 6 (booster), single (Lot number: G53277) at the age of 56 years, in right arm 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), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATORVASTATIN, start date: 01Sep2022, stop date: 06Feb2023; ANASTROZOLE, start date: 11Jan2021, stop date: 06Feb2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (Feb2023) Positive, notes: Positive COVID antigen tests. Therapeutic measures were taken as a result of drug ineffective, covid-19.
This is a spontaneous report from a contactable consumer (patient). A 70-year-old female consumer received unspecified dose number of BNT162B2 (solution for injection; Batch/Lot Number: EN6203) via an unspecified route of administration on 22Feb2021 as single dose for COVID-19 immunization. Medical history included hypertension, diabetes mellitus and thyroid. Concomitant medications included metoprolol, lisinopril, glipizide, metformin. On 22Feb2021, the patient experienced swelling in my face and arm was extremely sore and tender. No treatment received for the adverse events. The outcome of the event arm is extremely sore and tender was recovered and swelling in face was not recovered.
PA had biopsy of blister on chest, histology = Bullus Pemphigoid; skin blisters; This is a spontaneous report from a contactable physician (patient). A 75-year-old male patient received the first dose of BNT162B2 via an unspecified route of administration on the left arm on 13Mar2021 at 12:00 (Lot Number: EN6206) at the age of 74-year-old as single dose for COVID-19 immunization. Medical history included hypertension benign. Covid prior vaccination was none. The patient performed Covid tested post vaccination. Known allergy included sulfa. The patient didn't received other vaccine whit in four weeks. Concomitant medications included apixaban (ELIQUIS), valsartan, metoprolol, colecalciferol (D3), ubidecarenone (COQ10 [UBIDECARENONE]) and ch 14.18. On 23Mar2021 at 13:30, the patient experienced skin blisters (two or three after first dose) then 10 to total leg blisters after second dose. Treated by (name), referred to Dermatology center in (name) had biopsy of blister on chest, histology = Bullus Pemphigoid. On 17Aug2021, the patient performed Covid test post vaccination. The type was blood test, the name was antibody and the result was negative. Treatment was received. The outcome of events was recovering.; Sender's Comments: Based on the narrative information provided, a causal association between the reported event Pemphigoid and  BNT162B2 vaccine cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.