chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Stroke; Diabetic Ketoacidosis; A spontaneous report was received from a consumer concerning a 77-years old, male patient who experienced the events cerebrovascular accident and diabetic ketoacidosis.   The patient's medical history included hypertension.  Concomitant product use was not provided by the reporter.  On 06 Feb 2021, prior to the onset of the events, the patient received his first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly  for prophylaxis of COVID-19 infection.    On an unknown date, the patient experienced stroke and diabetic ketoacidosis. which caused hospitalization.  On 13 Feb 2021, the patient was admitted to the hospital. On 04 Mar 2021, the patient was discharged.  Treatment details was not provided.  Action taken with mRNA-1273 in response to the events was not unknown.  The outcome of the events cerebrovascular accident and diabetic ketoacidosis was unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time. However, the patient's advance age, diabetes, Hypertension, may remain contributing factor for this event.Further information has been requested
Patient called 10-7 to report shot given too high, hit a nerve, no fever, no red arm or swollen, she stated tingling when shot given but did not tell person, called back 10-18, not better or worse, "we nicked a nerve", I told to call her Dr.
Within an hour after shot severe muscular pain, could not move left arm, throbbing pain continuously as pain increased to shoulder (back and front) neck and jaw.  pain increased by the hour,  taking 2 Tylenol xtra strenght every 3 hours and NO relief.  Somewhat nauseous periodically.  Have high threshold for pain and this was worse the childbirth AND gall stones.  Considered calling 911.   This high level of pain lasted over 24 hrs before any degree of relief.  Pain SLOWLY subsided over the next 4-5 days.   Still have muscle soreness today.  this is the 1st of 2 shots and do not plan to have the 2nd shot unless I have on hand serious pain relief as oxycodone  /percocet etc.
This case was reported by a physician via sales rep and described the occurrence of injection site redness in a child male patient who received FLUARIX QUADRIVALENT (batch number MN5CS, expiry date June 2017). On 15th November 2016, the patient received FLUARIX QUADRIVALENT .5 ml. In November 2016, less than a week after receiving FLUARIX QUADRIVALENT, the patient experienced injection site redness and injection site pain. On an unknown date, the outcome of the injection site redness and injection site pain were not recovered/not resolved. The reporter considered the injection site redness and injection site pain to be almost certainly related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The age at vaccination was not reported. The patient received a dose FLUARIX QUADRIVALENT season and a red painful area appeared (11 centimeter) across at the injection site. Till the time of reporting, these reaction had not subsided. The sales representative did not have age or date of birth for the patient, limited information was provided. The healthcare professional would like to be contacted about this adverse event.
Patient presented to COVID clinic with father, vaccine drawn, RN double checked the vaccine name and dose (0.2ml), vaccine administered per fathers consent. At the end of the clinic received call from pharmacist and she asked if pfizer-peds vaccine was diluted, because she found the normal saline vial in the vaccine clinic unused. Confirmed with her this RN did not dilute the vaccine and asked the other RN she also stated she did not dilute the vial either. This RN assumed the vial was already prepared and drew up and gave vaccine as is. The pediatrician, immediate supervisor and vaccine coordinator (pharmacist) were all notified of the medication error. Parent was called and notified of incident.
The day after my covid booster, I woke with a large amount of swelling under my arm, in the armpit. I have heard of and experienced swelling at the injection site but not this so I thought it would be good to report it. There is almost constant discomfort, and it prevents me from letting my arm fully relax at my side or lifting my arm above my shoulder without pain. The amount of swelling is fairly large, as when I look into the mirror, my armpit no longer has a concave profile. It is now convex. I had gotten 2 other vaccines that day. They were a Tdap and a flu shot, although I do not know the brand or lot number. I selected Tdap(Boostrix) and Influenza (Seasonal)(Fluzone Quadrivalent), but that was just a guess, because I had to choose something on the list. The swelling in my armpit is on the left side, which is the same arm as where I got the covid booster and I believe the flu shot. I think the Tdap shot was in my right arm, but I might be mixing up which arms the flu and Tdap shots went into. I have not gone to my physician, because it has only been about 36-40 hours, and the swelling has gone down slightly (but not much).
pt recv vax 6OCT95 & 21OCT97 pt devel approx six skin lesions w/no other sx;
7 employees @ 4 facilities recvd an unspecified number of doses of Engerix-B or Heptavax & were found to be nonresponders; one employee had pos antibodies when pregnant & neg antibodies p/baby was born;
patient would be in bed for 3 days sick with the flu; patient would be in bed for 3 days sick with the flu; Initial information regarding an unsolicited valid non-serious social media case was received from a non-healthcare professional (consumer) on 11-Dec-2020.  This case involves Adult patient who would be in bed for 3 days sick (Sickness) with the flu (Influenza), while patient received vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), concomitant medication (s) and family history were not provided.  On an unknown date, the patient received a dose  of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On unknown date, (unknown latency) the patient would be in bed for 3 days sick (Sickness) with the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as unknown for both events.  There will be no information available on the batch number for this case.
kind of panicking; The heart is elevated, but not a whole lot; Thought that it was anxiety; felt like her heart was beating "really bad/it happened again during the day. And last night, it happened again; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (felt like her heart was beating "really bad/it happened again during the day. And last night, it happened again), HEART RATE INCREASED (The heart is elevated, but not a whole lot), ANXIETY (Thought that it was anxiety) and PANIC ATTACK (kind of panicking) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT), BETAHISTINE HYDROCHLORIDE (VERTEX [BETAHISTINE HYDROCHLORIDE]), DOCOSAHEXAENOIC ACID, EICOSAPENTAENOIC ACID, TOCOPHEROL (OMEGA 3 [DOCOSAHEXAENOIC ACID;EICOSAPENTAENOIC ACID;TOCOPHEROL]), MAGNESIUM, ZINC and NICOTINIC ACID (B3 NIACIN) for an unknown indication.    On 23-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Aug-2021, the patient experienced TACHYCARDIA (felt like her heart was beating "really bad/it happened again during the day. And last night, it happened again) and ANXIETY (Thought that it was anxiety). On 24-Aug-2021, the patient experienced HEART RATE INCREASED (The heart is elevated, but not a whole lot). On 25-Aug-2021, the patient experienced PANIC ATTACK (kind of panicking). At the time of the report, TACHYCARDIA (felt like her heart was beating "really bad/it happened again during the day. And last night, it happened again) and HEART RATE INCREASED (The heart is elevated, but not a whole lot) had not resolved and ANXIETY (Thought that it was anxiety) and PANIC ATTACK (kind of panicking) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: high (High) the heart is elevated, but not a whole lot.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included Women's multivitamins. No treatment details were reported.  It was stated that she has a Whoop band that tracks the heart rate during exercise and every time she felt like her heartbeat was elevated. She was planning on going to the doctor today
Severe headache, shortness of breath, stomach ache, diarrhea, minor leg pain, moderate all-body soreness.  Symptoms have abated except for headache and shortness of breath. These have only reduced in severity.
Patient had a red 3" circle at the injection site - circle had 4-5 small raised reddened welts - arm was very sore and felt tingley
INCORRECT PRODUCT STORAGE; PATIENT WAS ADMINISTERED VACCINE AFTER THE VIAL UNDERWENT MULTIPLE TEMPERATURE EXCURSIONS; This spontaneous report received from a health care professional concerned a male of unspecified age. 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, and batch number: 201A21A expiry: 21-SEP-2021) dose was not reported, administered on 13-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-SEP-2021, the patient experienced patient was administered vaccine after the vial underwent multiple temperature excursions. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the patient was administered vaccine after the vial underwent multiple temperature excursions and incorrect product storage was not reported. This report was non-serious.
Red raised itchy rash started AM of 12/24/09 site of rash was outside of both knees. Rash seemed to get worse on 12/25/09 and peaked on 12/26/09 and spread to include all extremities and main trunk of body. On 12/27/09 in AM symptoms seemed to subside and as of 12/28/09 rash is almost gone.
sterile water was used to reconstitute the vaccine, with no reported adverse event; Initial information received on 26-May-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who experienced sterile water was used to reconstitute the vaccine, with no reported adverse event while receiving vaccine YELLOW FEVER VACCINE - US [YF-VAX].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included WATER FOR INJECTION (STERILE WATER) for Vehicle solution use.  On 26-May-2022, the patient received a  dose of suspect YELLOW FEVER VACCINE - US lot number not reported via unknown route in unknown administration site for Immunisation.  On 26-MAY-2022 (latency: Same day) the patient developed a non-serious sterile water was used to reconstitute the vaccine, with no reported adverse event (product preparation error) following the administration of YELLOW FEVER VACCINE - US.  Action taken with YELLOW FEVER VACCINE (YF-VAX) was not applicable.  It was not reported if the patient received a corrective treatment for the event (sterile water was used to reconstitute the vaccine, with no reported adverse event).  At time of reporting, the outcome was Unknown for the event sterile water was used to reconstitute the vaccine, 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.
Case number PHEH2016US023384, is an initial spontaneous report received form a nurse on 13 Set 2016. This report refers to a 22-year-old patient of an unknown gender. Medical history and concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515701, expiry date: not reported) at a dose of 0.5 ml intramuscular into right arm on 01 Dec 2015. It was reported that, the patient received FLUVIRIN that had been exposed to 8 to 10 temperature excursion and it was administered to unknown number of patients. No adverse event was reported following this medication error (incorrect product storage).
some of the vaccine leaked down her arm; A spontaneous report was received from a healthcare professional concerning a 73-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced incorrect dose administered.  The patient's medical history was not provided. Concomitant product use was not provided.  On 13-Jan-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 012L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 13-Jan-2021, the patient received a partial dose of the vaccine because some of it leaked down the patient's arm.   No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not provided.   The event, incorrect dose administered, was considered resolved on 13-Jan-2021.; Reporter's Comments: This case concerns a 73 year old female patient who experienced a non-serious unexpected event of  Incorrect dose administered of mRNA-1273 vaccine.
36hr post vax pt devel hive-like raised erythematous area;-now @ 42hr is 4.8 cm x 3cm @ max diameter minimally tender;lt inguinal node minimally tender & sl itchy;
High-pitched abnormal crying/screaming lasting greater than 4 hrs; Seen by MD, was put on ATB x 1 wk (sore throat), felt hot (temp not measured);
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2, Solution for injection), on 03Nov2021 as dose 3 (booster), single (Lot number: EW0186) at the age of 41 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 18May2022, 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: Got a negative antigen test 6 days after testing positive; (unspecified date) Negative, notes: Got a negative antigen test 6 days after testing positive; (28May2022) Negative, notes: Continued to test negative until Saturday, 28May2022, when an antigen test showed a faint line; (29May2022) Positive, notes: Continued to be positive on 29May2022 and 30May2022; (30May2022) Positive, notes: Continued to be positive on 29May2022 and 30May2022. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid treatment started on 19May2022 and treatment stopped on 24May2022.  Clinical course: The patient had a mild case of COVID-19, with symptoms starting on 18May2022. Symptoms resolved within 3 days, and got a negative antigen test 6 days after testing positive. Continued to test negative until Saturday.
No additional AE reported.; The MMR-11 expired; This spontaneous report was received from a nurse referring to a patient of unknown gender and age. Information regarding the patient's pertinent medical history, current condition, drug reactions/allergies and concomitant medication were not provided.  On 28-JJUN-2021, the patient was vaccinated with expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) with albumin status rHA (recombinant Human albumin) 0.5 ml, once (strength, route of administration and anatomical site of vaccination were not reported, lot # S018592, expiration date reported and validated as 17-JUN-2021) for prophylaxis (expired product administered). No additional adverse events reported.
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (159558). A female patient received BNT162b2 (BNT162B2), 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: ILLNESS (non-serious), outcome "unknown", described as "ended up sick for weeks now". Additional information: Reported stated some of his family took the Pfizer COVID 19 vaccine. His mom took the vaccine and ended up sick for weeks now after receiving the vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
EXTREME Less than 2 hours after the injection my eyes starting  started bothering me.   All of a sudden , both eyes were extremely bad. My vision was frightening.   I saw a vertical dark (black but  could see through) filter, moving across my vision horizontally. My vision was a wave (dimensional) moving horizontal with a dark (see thru black filter) moving across it.  I could still see, but totally distorted.  Never in my life have I had anything like this.  I am not sure exactly how long  this lasted, maybe 15 - 20 minutes.  I sat down and covered my eyes and did not move for over 1.5 hours.   I did not call an ambulance,  because at that point  I knew it was a reaction. If it did not stop I would of called an ambulance.  Yesterday (Monday) I  went back to and told the pharmacist about my reaction.  This reaction was horrible.
Patient states she received her COVID-19 vaccine on Friday, March 5, 2021. Reports she noticed "it was high up on her shoulder". Reports asymptomatic at time of vaccination and when leaving facility. Reports later in the evening her "whole arm was sore and stiffened and she wasn't able to move it without a great deal of pain". Also describes lost range of motion. Rated pain at a 7-8/10 at that time. Reports she was not able to "get ready or dressed in the morning". Reports "roughest" Friday night through Saturday. States she did not do much on Saturday. Patient stated she used ibuprofen every 4 hours and iced injection site for 15 minutes without effectiveness.
Patient blacked out shortly after receiving vaccine for a few seconds.  Later reported numbness in the same arm while at football practice.
This patient received a flu vaccine and a pneumonia vaccine in the same arm. She immediately noticed severe swelling in her arm, pain, and she started to feel sick. By that evening she was bedridden with flu-like symptoms,complaining of flu like symptoms with fever and chills and aches all over her body. She could not eat or drink for several days. On Monday she presented back to the pharmacy, looked very weak and pale and her arm was still red, rashy and swollen. I advised her step over to her physician's office to make sure she was going to be okay, and to try to get some liquids in her.
cluster headaches; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: Fa7484), via an unspecified route of administration in left arm on 23Jul2021 (at the age of 44-years-old) as dose 2, single for COVID-19 immunization. Medical history included hypertension and hypercholestremia. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive any vaccines within four weeks nor any other medications within two weeks prior. The patient was not having any known allergies and was not pregnant. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: Ew0181), via an unspecified route of administration in left arm on 03Jul2021 11:00 (at the age of 44-years-old) as dose 1, single for COVID-19 immunization. The patient experienced cluster headaches on 27Jul2021 16:00. The event resulted in emergency room or department or urgent care visit. The patient was treated with Oxygen and sumatriptan. Since the vaccination, patient has not been tested for COVID-19. Outcome of event was not resolved.
Havrix given after temperature excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 2-year-old female patient who received HAV (Havrix) (batch number F7X23, expiry date 25th May 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th December 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date:16-FEB-2023 Reporter's Comment: The reporter called to inform that a dose of Havrix that had been in a below temperature excursion and was not considered stable was administered to a patient. The reporter stated that below temperature excursion had happened in October. The Vaccine Administration Facility was the same as primary reporter. The reporter consented to follow up.  Additional Supportive Information: The reporter called to inform that a dose of Havrix that had been in a below temperature excursion and was not considered stable was administered to a patient,which led to incorrect storage of drug. The onset date for incorrect storage of drug was earlier than vaccination date, so onset date was not captured in the case.  This was 1 of 5 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023026693:Same reporter US-GSK-US2023026694:Same reporter US-GSK-US2023026695:Same reporter US-GSK-US2023026696:Same reporter US-GSK-US2023026698:Same reporter
The client and his mother entered the mobile vaccination tent, via automobile, to receive an initial dose of Pfizer vaccine. The client pulled up his sleeve to receive vaccine dose in left deltoid by the vaccinator. A second vaccinator approached the vehicle with the intent to vaccinate the other party in the vehicle, however, the client pulled up his right sleeve and received another dose of the Pfizer vaccine. The vaccination team became aware when the other party in the vehicle (mother), inquired about the client receiving two doses in one day.
Headache, Myalgia, headaches, sinus pressure, bodyaches, tingling and numbness of face and tongue since 1230pm 2/5/21 and right arm pain, heaviness Narrative:
After several hours my heart rate reached 150bps at a resting state. My heart was popping out of my chest and I felt really bad  chest tightness and pressure very cold.
Breakthrough case admission after 2 vaccines Moderna 3/1/21 Lot# 023M20A;  Moderna 3/29/21 Lot# 018B21A;