chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Total knee replacement; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 12Sep2022 at 13:00 as dose 4 (booster), single (Lot number: FK9893) at the age of 68 years intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Anatomical site of injection: Arm Left, Route of administration: Intramuscular, Batch/Lot number: EN6205), administration date: 09Mar2021, for COVID-19 Immunisation; BNT162b2 (DOSE 2, SINGLE, Time (24hr): 15:00, Anatomical site of injection: Shoulder (deltoid), Route of administration: Intramuscular, Batch/Lot number: EW0158), administration date: 12Sep2021, for COVID-19 Immunisation, reaction(s): "Inappropriate schedule of vaccine administered"; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Time (24hr): 10:00, Anatomical site of injection: Shoulder (deltoid), Route of administration: Intramuscular, Batch/Lot number: EW0187), administration date: 05Nov2021, for COVID-19 Immunisation. The following information was reported: KNEE ARTHROPLASTY (medically significant) with onset 15Feb2023, outcome "not recovered", described as "Total knee replacement". Therapeutic measures were taken as a result of knee arthroplasty which included physical therapy. Clinical course: Anatomical site of injection was Shoulder.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300111188 same patient, different dose/event;
Moderate arm soreness, chills, fever (101 F), upset stomach, fatigue.
Her shoulder and deltoid became red; Her shoulder and deltoid became red and welted; the welt measures about 10x 10 cm; Initial information received on 05-Oct-2022 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves a 58-year-old female patient whose shoulder and deltoid became red and welted; the welt measures about 10x 10 cm while receiving vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (strength, formulation, dose, route, frequency: unknown) (lot number: UJ888AA and expiry date: 09-Jun-2023) in unknown administration site for Immunization.  On 04-Oct-2022, the patient developed non-serious events of, her shoulder and deltoid became red (erythema) and welted; the welt measures about 10x 10 cm (urticaria) (unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  It was reported, she has the LOT and EXP for a product but is not sure what the product name is. Reporter mentioned that the product does not contain any egg which would make the product the FLUBLOK vaccine. Caller mentioned that an employee had a reaction to a preservative containing flu product last year, unknown which product manufacturer, and would like to know if the flu product they currently have has any preservative in it. Reported, that the employee received the product on 4Oct2022 and developed a localized reaction. It has not spread or gotten any worse. Caller also asked what other flu products if any does? She would like to know if a patient is greater than 50 years old which product should they receive? She would like to know if any other of the flu products are a preservative free product?   Action taken with QUADRIVALENT RECOMBINANT INFLUENZA VACCINE (FLUBLOK) was not applicable.  Corrective treatment: They are putting warm compresses for the events.  At time of reporting, the outcome was Unknown for both events.
Patient came in on 10/5/07 (3 days later) with red, raised area on left arm. She stated she felt nauseous and that the raised red place was growing bigger over the last 3 days. She was given Claritin 10 mg tablets once daily for 7 days and asked to report to doctor immediately. Contacted doctor on 10/9/07 - pt determined to have skin infection and was treated with Cephalexin for 7 days. Per pt arm is back to normal.
Severe chills   High Temperature for three hours rising to 104.7. Low grade fever and headache for next 24 hrs
Patient called the day after vaccination. She said that her arm was red around the injection site (about a 4X4 area) and slightly warm to the touch. No swelling. It was slightly itchy. No pain. No other effects. I told her she could take some BENADRYL by mouth and use cold compresses (if she wanted or felt she needed the cold compresses). I also asked her to contact me if it got any worse.
Whole 2nd half of May was nonstop menstrual period. Paused June 1-3. By June 4 was heading into a 3RD WEEK of continual bleeding!!! Gonna make appt with Gyno doc this week to see what can be done to make it stop
soreness around the flu shot injection site; This case was reported by a consumer via other manufacturer and described the occurrence of injection site pain in a 41-year-old male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   In November 2020, the patient received Influenza vaccine Quadrivalent 2020-2021 season. On an unknown date, less than 2 months after receiving Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient had flu shot and he had soreness around the flu shot injection site and it lasted for few days, and it was better now.
Around 5:00 AM noticed a rash on neck and abdomen, felt hot.  Left work at 6:30 AM, went home took Benadryl.  Went to bed at 8:00 AM.  Woke up at 9:30, jumping out of skin.  Noted golf ball sized welps all over.  Had swollen neck, tight, couldn't breathe; diarrhea.  Went to ER at 9:45 AM.  BP elevatetd, pulse rate elevated. At the ER, staff administered Epinephrine, Benadryl, Phenergan, zantac, prednisone and a dose of an antibiotic (possibly Keflex).  Monitored her for about 2 hours and released home to be off work for 24 hours.
Information has been received from a Licensed Practical Nurse concerning an unspecified numbers of patients. On an unspecified date, the patients received a batch of improperly stored LIQUID PEDVAXHIB (dose, strength, route and lot# were not reported). No adverse effects reported. Follow up information has been received on 01-APR-2015 from the Licensed Practical Nurse via a telephone call. The lot number and expiration date for the LIQUID PEDVAXHIB vaccination was provided: lot number: K008877, expiration date: 24-FEB-2017. The nurse reported that patient identification information was not readily available at the time of the call and there were no reported adverse event. This case was one of the 7 reports from the same reporter (other two products were captured in case 1502USA005910, 1503USA003159, 1504USA002730 and 1504USA002731; the other two reports concerning the same product was captured in 1504USA003187 and 1503USA003160). Additional information has been requested. Product and narrative were updated.
Sore arm; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy (Allergic to pen K).   On 27-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided.   This case was linked to MOD-2021-182314 (Patient Link).
I have the vaccine got the night, yesterday and I get sick; I have my veins on my leg popped out, in case  in my veins, lot of boils.; I have my veins on my leg popped out, in case  in my veins, lot of boils.; one side like my legs, just don't have the power; I am tired already and I don't feel well; I had lot of bones feel bad in my neck; I am tired already and I don't feel well; This is a spontaneous report from a contactable consumer (patient herself). A 75-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID 19 mRNA VACCINE; Solution for injection; Lot Number: EW0187, Expiration date: 31Aug2021) via an unspecified route of administration on 29Jun2021 as a dose 1, 0.3 ml single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had got the vaccine the night yesterday and got sick. She had her veins on leg popped out in case as lot of boils. "Popped out, out, you know when your veins gets bigger, this is popped off. When your veins get bigger and make a boils in there. You know what is a boils, like one little ball." She had a concern, why she had that? Is it going to worse or is it going to be disappear or what is going to do that to me? I need to know why, first place. Second place, if its not danger. Third place, if its going to be disappear. Patient stated that she don't want and no other get problems with the vaccine. The patient stated, "No, I am not. I am tired already. I am tired already and I don't feel well." and hung up the call, hence limited information available over the call." The patient further stated that she had pain in left leg and feel like, she was going to one side like her legs, just don't have the power. Additional information included that patient reported that she had yesterday, the Pfizer BioNTech covid-19 and today a very bad plug, in veins, pop off and had lot of bones feel bad in my neck. She wants to know what I can do? If its bad or is going away or what happen and also she had pain in my leg. Like in my left leg and I feel like, I am going to one side like my legs, just don't have the power. Therapeutic measures were not reported. Clinical outcome of the event was unknown.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from a practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 05-JUL-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength and route were unknown) (lot# N022728 and expiration date 31-MAY-2020) for prophylaxis (Incorrect product storage). No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA001951; US-009507513-1810USA001952; US-009507513-1810USA001953; US-009507513-1810USA001954; US-009507513-1810USA001955; US-009507513-1810USA001957; US-009507513-1810USA001958; US-009507513-1810USA001959; US-009507513-1809USA003709.
Lymph nodes under left arm were swollen for approximately one week after booster vaccine. Upper Left arm was still sore when raising and lifting for approximately 3-4 weeks after booster vaccine. Upper Left arm still feels 'achy' when raising or lifting.
This spontaneous report has been received from a pharmacist referring to a patient of unknown age. On 25-NOV-2015 the patient was vaccinated with improperly stored M-M-R II (dose and route not reported, lot # L023385, expiration date: 25-JUN-2017) (incorrect product storage). No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
A SHOT WAS ADMINISTERED A DAY PAST BUD. No adverse drug reactions were noted.
VISUAL DISTURBANCE  SHORTNESS OF BREATH  SLEEP DISTURBANCE  ANXIETY FATIGUE LEG SWELLING NECK AND BACK PAIN  COVID MULTIPLE INFLAMMATORY SYNDROME   COAGULOPATHYT
Arm sore; Body not feeling well; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included TETANUS VACCINE for prophylaxis.   On 06-MAR-2023, the patient received Shingles vaccine and TETANUS VACCINE. On 07-MAR-2023, 1 days after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: Arm sore) and feeling unwell (Verbatim: Body not feeling well).  The outcome of the pain in arm and feeling unwell were not reported.   It was unknown if the reporter considered the pain in arm and feeling unwell to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm and feeling unwell to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 08-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he/she received Shingles vaccine on Monday and at the same time he/she received a Tetanus vaccine. On next day after received both doses the patient experienced his/her arm was sore and in fact his/her entire body was not feeling well. The patient stated that he/she will receive his/her next shingles vaccine in about two months. It was unknown if the reporter considered the pain in arm and feeling unwell to be related to Tetanus vaccine.    Follow-up would not possible as no contact details were available.
Fatigue, dizziness, confusion, tremors, brain fog, irregular menstrual period
Developed superficial thrombus in varicocele in left testicle, followed by multiple pulmonary embolisms.
Patient was administered dose of Pfizer instead of Moderna for her 2nd dose of COVID vaccination. Patient was monitored for 15 minutes post vaccination for any adverse reactions. A well as followed up on Monday 5/10 and again Thursday 5/13
I'm an FP physician - reporting on behalf of my father - although my father is taking immune therapy - within approximately 36 hours after receiving the second dose of Moderna he developed the anticipated side effects of body aches, fatigue, fever, joint pain however he also developed a sand paper like rash on his tongue and erythema and pain in his mouth these symptoms were fairly severe for 3-4 days and lasted  a total of 10 days. He chose not to take medication to treat. He did lose approximately 4 lbs which he has regained.   I didn't connect the two immediately but a close friend of mine who is a nurse - her sister had also had a similar event in close relation to having received the moderna vaccine - I've encouraged her to report as well.   I hope this information is helpful.
mom brought pt back to clinic p/prolonged crying (4-5 hrs); inject site (Tetramune) was red, warm & edematous; diam approx 8cm APAP given & Pediprophen;
Itchy red rash - small bumps, that appeared 8 days after injection. Applied some triamcinolone cream, cool compress. Rash has faded to pale pink, itches slightly.
pt brought in to MD office w/c/o screaming & jerky leg movements voiced by mom; referred to hospital; questionable sz;
It made my allergies worse. Originally, I was allergic to things in the environment.  After vaccinations, my allergies became worse. I almost died because my throat was closing and I didn't know what; It made my allergies worse. Originally, I was allergic to things in the environment.  After vaccinations, my allergies became worse. I almost died because my throat was closing and I didn't know what; It made my allergies worse. Originally, I was allergic to things in the environment.  After vaccinations, my allergies became worse. I almost died because my throat was closing and I didn't know what; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 04May2021 at 15:00 as dose 2, single (Lot number: ER8734) at the age of 47 years, in left arm for COVID-19 immunization. The patient's relevant medical history included: "Known allergies: Nuts" (unspecified if ongoing); "Known allergies : dairy" (unspecified if ongoing); "Known allergies: beef" (unspecified if ongoing); "Known allergies: seafood" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC ALLERGY. Vaccination history included: bnt162b2 (Dose Number: 1, Batch/Lot No: ER8737, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 06Apr2021, when the patient was 47-year-old, for Covid-19 immunization. The following information was reported: THROAT TIGHTNESS (life threatening), MULTIPLE ALLERGIES (non-serious), CONDITION AGGRAVATED (non-serious) all with onset 03Jun2021, outcome "recovered with sequelae" and all described as "It made my allergies worse. Originally, I was allergic to things in the environment.  After vaccinations, my allergies became worse. I almost died because my throat was closing and I didn't know what". The events "it made my allergies worse. originally, i was allergic to things in the environment.  after vaccinations, my allergies became worse. i almost died because my throat was closing and i didn't know what" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Jan2022) Positive, notes: Nasal swab. Therapeutic measures were taken as a result of throat tightness, multiple allergies, condition aggravated.  Additional information: Patient reported that it made her allergies worse. Originally, she was allergic to things in the environment. After vaccinations, her allergies became worse. She almost died because her throat was closing and she didn't know what it was. She was going to allergy doctors and they couldn't diagnose her. She had to diagnose herself. She could only eat chicken, pork and vegetables. Absolutely no diary, beef or nuts or anything that contained those items. Adverse event (AE) resulted in Doctor or other healthcare professional office/clinic visit. Patient recovered with lasting effects. AE treatment included she had to take Benadryl three times a day. Vaccination facility type was Pharmacy/drug store.
Full LOC, fell from post vax chair (approx 2.5 ft) onto the cement floor, striking head upon landing. Patient regained consciousness ~30 seconds after syncopal episode. Patient reporting posterior head pain and stomach pain. Negative DCAPBTLS. Patient provided with ice pack to apply to head.  vitals at 05:17 PM were  BP: 100 over 60 HR: 88 BGL: 88 RR: 14  Patient refused an ambulance to be called and signed that he did not wish to go to the hospital. Advised to contact PMD should further symptoms occur.
About 30 days after the injection I started to have numbness below my waist along with other bizare symptoms. I woke up with numbness in my feet and it moved up to my waistline during the day.  04/12/15
Narrative:  Patient reported death after covid vaccine. 2 doses received. No other documentation listed in chart or reports of death.
This literature marketed report was received from the author of a published article and refers to a 2-month-old patient on an unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On an unknown date during an office visit, the patient was vaccinated with a dose of GARDASIL 9 instead of LIQUID PEDVAXHIB (dose, route of administration, lot# and expiration date were not provided for both), due to the vaccines name confusion.
Fever, chills, cold and hot sweat, soreness, and achy joints and muscles for 48 hours
-Extreme exhaustion starting end of week 2 and continued through weeks 3, 4 and 5; - Period came 4 days early and lasted 9 days; heaviest period I have had in 20 plus years; severe migraine, cramping and low back pain - weeks 3 and 4 had brain fog; difficult to make decisions - relayed above symptoms to Dr and he did bloodwork
No adverse reaction yet. Concerned that patient was given KINRIX, not appropriate for a 4 month old.
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. Concurrent conditions and medical history were not reported. On an unknown date, the patients were vaccinated with improperly stored dose of oral, ROTATEQ (Lot#L008996, exp.date 01-DEC-2016; Lot#L008054, exp.date 30-NOV-2016; Lot #K019370, exp.date 16-JUL-2016) (Strength, dose and frequency were not provided). Concomitant medication was not reported. This is one of several reports from same source. Additional information has been requested.
Throat felt tight about 30 min after injection. Got extremely tired and cold. I could breathe but it hurt to swallow. Stomach was burning a bit right under right rib cage. Head started to hurt at about the 1 hour mark. Lost all color in face - white as ghost.  Fell asleep for 2 hours and woke up with color and much better. Throat was just scratchy.   next morning throat was still scratchy but much better.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 18-AUG-2010 the patient was vaccinated with GARDASIL dose 1 (route, dosage and lot number unknown). The nurse reported that the second dose of GARDASIL dose 2 (route, dosage and lot number unknown) was going to be administered on 29-JUL-2013. No adverse effect reported. Additional information has been requested.
Patient's 4th COVID vaccination was supposed to be the Bivalent Pfizer vaccine.  However, the patient accidentally received the Pfizer monovalent vaccine.
Left facial numbness, tongue numbness, lip swelling, and non-radiating central chest pain. BP and other vitals all stable. Benadryl 50mg poX1 given to offset allergic reaction prior to chest pain. When chest pain occurred, patient was advised that an ambulance was need, but patient refused. Patient stated that she would have husband drive her across the street to the emergency room. Two hours later, attempted to call number on file and phone line was disconnected.
ADVERSE REACTION TO THE VACCINE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, 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, the patient experienced adverse reaction to the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adverse reaction to the vaccine was not reported. This report was non-serious.
Scratchy throat, generalized rash of small red bumps all over body and especially on arms/ legs.