chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; covid-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 24Sep2021 as dose 3 (booster), single (Lot number: 30155ba) at the age of 70 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 07Jan2021 as dose 1, single (Lot number: 011j20a), in left arm, on 04Feb2021 as dose 2, single (Lot number: 004m20a), in left arm and on 31Mar2022 as dose 4 (booster), single (Lot number: 048l21a), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Emphysema" (unspecified if ongoing). Concomitant medication(s) included: ATACAND; BYSTOLIC; CARDURA; CRESTOR. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Indication: Covid-19 treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Anti-viral treatment included Brand Pfizer started on 24May2022 for Treatment of COVID-19 and stopped on 29May2022. Other medications in 2weeks product included Atacand 32 mg, Bystolic 10 mg, Cardura 4 mg, Crestor 20 mg.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200850354 Same patient, different product and event;
Mild redness, mild swelling and mild pain at the injection site. Redness is 1.5 inches in diameter.
Patient developed sharp chest pain in the evening for 2 consecutive days. Evaluation was performed as per recommendations, but my opinion is that his symptoms were not related to his smallpox vaccination.
The area is red and spreading; Severe stiff neck; Severe headache; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unkknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site erythema, stiff neck and headache. On an unknown date, the outcome of the injection site erythema, stiff neck and headache were unknown.   It was unknown if the reporter considered the injection site erythema, stiff neck and headache to be related to Shingrix.  Additional details were provided as follows: The patient was reporting for herself. The age at vaccination was not reported. After receiving Shingrix, the patient's injection site area was red and spreading with stiff neck and severe headache. The patient asked is that normal.
heart rate is elevated when exercising or doing any walking.  an easy walk of 3 miles per hour on the treadmill will now have my heart rate higher than normal by 30 to 40 beats or more.  doing anything other than a light workout has not been possible for the last 6 weeks.
PASSED AWAY; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer via a company representative via social media concerned a patient of unspecified age, sex, unknown race and ethnicity. 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: not reported, expiry: unknown) dose was not reported, 1 total, start therapy date were not reported 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 an unspecified date, patient had suspected Covid-19, suspected clinical vaccination failure and patient passed away from unknown cause. It was unknown if the autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was passed away on an unspecified date. The outcome of suspected covid-19 infection and suspected clinical vaccination failure was not reported.  This report was serious (Death, and Other Medically Important Condition). This case, from the same reporter is linked to 20210629346.; Sender's Comments: V0: 20210635272-Covid-19 vaccine ad26.cov2.s-Passed away This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210635272-Covid-19 vaccine ad26.cov2.-Suspected Clinical Vaccination Failure . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Red, swollen, painful arm.  Unable to use arm.  Tightness/pressure on chest.
vaccine had expired; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 13-month-old female patient who received HAV (Havrix 720 Junior) (batch number 94J24, expiry date 26th September 2021) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 29th September 2021, the patient received Havrix 720 Junior (intramuscular) and Havrix Pre-Filled Syringe Device. On 29th September 2021, unknown after receiving Havrix 720 Junior and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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 details were provided as follows: The age at vaccination was unknown. The SNP stated that, the patient was administered with Havrix vaccine in the right thigh and the nurse then noticed the vaccine had already expired. The reporter consented to follow up.
I received Moderna Covid-19 vaccine , Lot 016M20A, as 1st injection on 2/12/21.  On 3/12/21 I received 2nd shot of Moderna, Lot 029A21A.   After 1st shot I had slight tenderness at injection site and a headache for 3 days.  After 2nd shot, by evening I developed a red, swollen and itchy spot about the size of a fifty cent piece. The spot grew slightly in size but was receding and almost gone by 3/16/21.  Then today, the rash has intensified to become red, swollen, itchy and tender again.  I am also experiencing the headache again.   Just wanted to report on my Covid/Moderna arm.
This spontaneous report as received from a pharmacist refers to a 75 year-old female patient. The patient was allergic to penicillin. She had no pertinent medical history or concomitant medications. On 08-SEP-2017, the patient was vaccinated with ZOSTAVAX (exact dose and route of administration were not reported; lot # M041085 with the expiration date of 03-JAN-2018), for vaccination. The vaccine was reconstituted with sterile diluent (lot # N007932 with the expiration date of 06-MAY-2018). On 08-SEP-2017, the patient reported a raised red reaction at the injection site, which went away in a few days (exact date was not reported). On 18-SEP-2017, the patient came into the pharmacy and complained of having red splotches on both arms and redness at the injection site. The pharmacist reported seeing the redness at the injection site, but not the red splotches on both arms. No treatment was given for the events. No lab diagnostic studies were performed. No Product Quality Complaint (PQC) was involved. The patient's present status was reported as not recovered. The relatedness between the events and ZOSTAVAX or sterile diluent was not provided.
Patient was given a Pfizer bivalent booster and patient had received Pfizer Bivalent Booster prior on 09/15/2022. RN, at facility constructed a list of patients from one side of their facility that qualified boosters based on what they had on their EMR system. The resident that received the COVID vaccine wanted the bivalent booster. I was told that she was eligible for the dose and patient confirmed that she wanted it, and I explained info on the vaccine and gave opportunity for question prior to administration, resident had no questions. The error was discovered when the dose was being documented on the database.   Pt was admitted to to facility recently, and admission paperwork and discharge instructions from the hospital, did not include any recent administration of Covid vaccine based what they had on their system. Further questions with the resident lead to that she did receive a vaccine at a pharmacy on 09/15/2022 but wasn't entirely sure what it was. She mentioned she had a fall/fracture 09/16 that lead to hospitalization, so she has been forgetful since. FNP spoke with the patient for any concerns she may have had with the additional dose.   Patient was placed on charting for the next 48 hours
At approximately 1540 pt received Tdap, HPV, and MENACTRA. 1542 Post vaccine pt appears to have a syncope episode. Pt had body enclosed to herself and was violently shaking for approximately 20 seconds. 1543 Pt becomes pale and clammy to the touch. 1544 Nurse and staff place the patient in a back leaned sitting position. 1545 Pt vomits. Approximately 1/2 a cup with food chunks from a previous snack. 1547 An ice pack is placed behind her neck and the nurse and staff continue to talk to her and fan her to keep the pt from falling asleep/passing out. At approximately 1540 pt recieved Tdap, HPV, and MENACTRA. 1542 Post vaccine pt appears to have a syncope episode. Pt had body enclosed to herself a
Within 3-4 hours, my right shoulder had excruciating pain in the muscles and joints, so much so for the next 24 hours I couldn't move my arm or raise it without assistance with my left arm. The slightest motion or turning of my left arm caused me to cry out in pain. I experienced almost complete lack of mobility and excruciating pain in the right shoulder area.  I also experience a splitting headache that lasted for 24 hours.  And for 1-3 days felt extremely tired. The shoulder pain lessened after 24 hours, however even today my shoulder isn't completely mobile or free from pain.
Developed reddish spots on my forehead and few on my face, they are flat and do not itch. Had a low fever . Very achy and lethargic
get sick maybe once ever three years; Initial information received on 03-Jan-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves an unknown age and gender patient who reported get sick maybe once ever three years, while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   In 1992, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (dose, formulation, lot number not reported via unknown route in unknown administration site) as prophylactic vaccination.  On an unknown date, the patient developed a non-serious event "get sick maybe once ever three years" (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported" got the flu shot in 1992. It was a terrible. I had an adverse reaction to it and will never get another one. Fortunately I only get sick maybe once ever three years, maybe."  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (get sick maybe once ever three years).  At time of reporting, the outcome was Unknown for the event get sick maybe once ever three years.
At an eye exam.  I had retina  was swollen.  It was confirm to be a specialist to be a  posture cyrtid.  No surgery had to be done for this.  I went to the ER.  They did blood work, MRI and a CT scan of my brain.  It confirm their was a tumor.  I am going to need ongoing evolution and care for this.
11 cm x 17 cm erythematous, pruritic patch on leg surrounding injection site.
On Monday, May 6, I went in to the office of Dr. with absolutely nothing wrong with me.  I was feeling good and just went in for the first yearly check-up since I came to this state.  I assumed that they would have requested my records from former doctor's office; but apparently not, I have since found out.    Dr. suggested a tetanus shot.  I assumed she had records to indicate that I needed one.  I waffled and then said, OK--because I was not sure how long it had been and my personal records were at home.  Also, just this moment I discovered she gave me Tetanus, Diphtheria and Pertussis.  She only mentioned I needed a Tetanus shot.  A day later I started itching around my torso.  I just figured it might be a small reaction to the shot and didn?t think too much about it so I waited for it to get better--for about two weeks!!!  but by Friday, May 24, I was itching terribly and I had an itchy, spotty red rash from my neck to my ankles.  I wrote a note to your office requesting some help.  By Tuesday, May 28, I had received no call so I wrote another note requesting some help.  The rash was now raised in places and there were tiny pin-prick sores in random places.  No one called me back.  So I called--thinking I would get a nurse.  Instead, I got a very sympathetic lady who made all kinds of suggestions that I had already tried and when I asked my last question, she asked, ?Oh.  Did you want to speak to a nurse??  I said yes and she indicated that she was not a nurse.  So that was that.  Instead of getting me a real appointment, she scheduled me a video appointment for Friday, May 31.  After understanding that the appointment would require me to take pictures of my rashy naked body from head to foot and then send them to the doctor, I cancelled because that is not something that I am comfortable doing and doesn?t seem very professional way to treat something that?s been going on for 3 weeks.  Sometime in all of this I woke up with a jaw that would not open very well.  That lasted for about three days so that I could only eat very soft things.  Every day I would wake up and hope that today would be better, but no, not really.  I think a nurse called me once but never offered to get me an appointment so someone could look at what was going on.  My jaw has since returned to almost normal.  Occasionally it will hurt when I first open my mouth.  But my rash continues unabated.  It is just getting less itchy.  My husband is acquainted with a medical doctor and he asked how I was and my husband explained my predicament and my concern that it was a reaction to a tetanus shot.  His reply: ?Oh, yeah.  It happens.  Takes sometimes 6-7 weeks to get over it.?  The dermatologist with whom I have an appointment in two days agreed as well.  So I keep waiting.  It?s now been 5 weeks.
After the 15 minute waiting period, I felt fine. I did my grocery shopping while I was at the store, went home and worked the rest of the day at my desk. We ran errands in the evening like normal. I hadn't really noticed because we were busy, but my heart rate had been steadily increasing all afternoon and into the evening. My watch tracks my pulse rate and reports on screen. After I took a shower at 9:30, I noticed that my pulse felt high. I laid down, thinking it was just from taking a hot shower and it would go back down to normal.  That's when I looked at my watch report and it looked like a stair step, with my heart rate increasing steadily every few hours, starting at 4 p.m. It was currently 110-120 (my normal RHR is 60, and drops into the 50s when I'm asleep). I went to bed, hoping I was just in my own head about this and it would be fine. I woke at 2 a.m.  and my heart rate had not dropped below 100 while I was asleep and was at 130. I went to the ER at 2:00 a.m. because it was alarming. There were points where it spiked to 150 while sitting still. The ER ran an EKG, full blood and urine labs, monitored my heart rate and BP - my BP was in the normal range the whole time. The doctor who saw me in the ER was awesome. Her husband is still dealing with lingering neurological damage from having COVID last year. She informed me that I was not in a-fib or any type of cardiac distress and my labs were all normal, but was likely having an immune response to the vaccine.  They did a chest x-ray and CT to check for blood clots and both came back negative. My platelet count was well within normal range as well. I returned home about 6 a.m.  and my heart rate was still higher than normal, but had already started to work its way down. It stair-stepped down just like it went up and by 4 p.m., my RHR was back down to 70 and it was down in the 50s overnight. Aside from that, I had the typical headache, low-grade temp and overall body aches. Everything had subsided by Sunday afternoon. I did make an appointment see my PCP as instructed by the ER doctor on Tuesday, April 13. She had read all reports from the ER and was pleased with how my heart rate had come back down to normal. This was the same day that the authorities stopped use of the Jannsen shot due to the blood clot concerns. Dr ran another platelet count for my own peace of mind and it was a little higher than it was when I was in the ER, so she was confident that I was not in any danger, but did review the symptoms/warning signs of blood clots with me just in case.  I have not had any issues or symptoms since.
Swelling of upper arm, Red area about 3 fingers wide 2 inches below from injection site, very, very tender to the touch.
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 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Jan2021 at 10:30 as dose 1, single (Lot number: EK4176), in right arm, on 28Jan2021 at 15:30 as dose 2, single (Lot number: EL3249), in right arm and on 02Jul2021 at 10:30 as dose 3 (booster), single (Lot number: EW0181) at the age of 57 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing); "Known allergies: Shellfish" (unspecified if ongoing). Concomitant medication(s) included: INDOLE-3-CARBINOL, start date: 06May2017, stop date: 19Jun2022; SUPER B COMPLEX [VITAMIN B COMPLEX], start date: 24Apr2017, stop date: 19Jun2022; VITAMIN D 3, start date: 08Sep2016, stop date: 19Jun2022; MAGNESIUM, start date: 08Sep2016, stop date: 19Jun2022; FISH OIL, start date: 24Apr2016, stop date: 19Jun2022; CALCIUM, start date: 08Sep2016, stop date: 19Jun2022; CENTRUM [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM;CHLORINE;CHROMIUM;COPPER;CYANOCOBALAMIN;DL-ALPHA TOCOPHERYL ACETATE;FOLIC ACID;IODINE;IRON;MAGNESIUM;MANGANESE;MOLYBDENUM;NICKEL;NICOTINAMIDE;PANTOTHENIC ACID;PHOSPHORUS;PHYTOMENADIONE;POTASSIUM;PYRI, start date: 24Apr2017, stop date: 19Jun2022. 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 antibody test: (unspecified date) Positive, notes: COVID 19 Treatment; (11Jul2022) Negative, notes: Tested negative twice. Therapeutic measures were taken as a result of drug ineffective, covid-19 of Paxlovid with lot number: GC4800.  Clinical course: the patient received other medication in 2weeks.   No follow-up attempts were possible. No further information was expected.
Pt reports soreness, tenderness and pain in right upper arm area. Developed shortly after Td booster, unresolved three months later. Pt denies any swelling or erythremia in right upper arm following injection. Palpation of right upper arm reveals no erythremia, or swelling, no lumps, and although patient states arm is sore in this area, no guarding or flinching occurs during palpation. Pt reports pain in right shoulder area that prevents her from sleeping if she rolls over onto it in her sleep. Pt reports pain with excessive movement. Pt reports regular use of Tylenol has not resolved pain. Pt also reports increased soreness and stiffness in right shoulder area upon waking in the morning.
Injection site rash - Information has been received from a physician concerning a 26 year old female who was vaccinated with one dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation).  Concomitant therapy included one dose of tetanus toxoid, one dose of hepetitis b vaccine (manufacturer unknown) and one dose of Modimmune.   Subsequently the patient developed a 5-6 cm red rash approximately 5 minutes post - injection. The rash was located at the measles (=) mumps (+) rubella (MSD) vaccination site.  Unspecified medical attention was sought.  Additional information has been requested.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 20-NOV-2014, the patient was vaccinat4ed with VARIVAX (Merck) (dose strength and route was not reported) (lot # J014402 and expiry date: 13-NOV-2015) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting VARIVAX (Merck), nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects report4ed. No product quality complaint (PQC) was reported for VARIVAX (Merck). This is one of the several reports from the same reporter. Additional information has been requested.
The first day felt fine, the next day when she got up in the morning she didn't feel well, but felt well enough to put a roast in the crockpot.  Felt then headache, aching in all joints and muscles with achiness.  Felt it in her heart, short of breath.  The following day felt worse, just wanted to sleep, freezing cold and her temp was low, she could not get warm, and went back to bed and stayed there.  She could not eat much, drank water.  The following day after that felt a little bit better.  She feels about the same she did yesterday, heaviness of her legs especially her knees, weakness and fatigue.  Had a pressure like headache in the top of her head and back of her head, right side of her face.  The 2nd day the pain was up her neck on the right side, it hurt bad.   All her joints are hurting, she does have arthritis.  Also having back pain.  The 2nd day took Tylenol a couple of days, and took 1/2 pill of Hydrocodone, which causes liver/stomach pain.  Not in the pain in the muscles now just a heaviness in her legs and shaky.  Called her doctor who did not have much information and informed to call us.