chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A few days after taking the Janssen vaccine, I stated to experience issues breathing and swallowing. Sometimes feels like I'm trying to breathe and swallow at the same time but nothing happens and I'm left gasping for air. I've had to carry a gallon of water around with me the last 3 week. Whenever I cannot breathe or swallow, I have to put water in my mouth quickly to get back to swallowing normal. I've been into the Urgent Care - Oxboro and a check x-ray was done along with a blood test. Nothing concerning was found according to the doctor and I was told to continue monitoring. It's been almost a month and I'm still having lots of difficulties swallowing/breathing. Tonight, as I'm typing this out, is a lot worse. Have medical insurance which covers 3 visits annually and I've used those on rushing into the Urgent Care to get checked out - therefore, I haven't been able to go into the ER to get checked out further since that'll be an out of pocket cost.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Covid-19 treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Caller mentioned that she had all her Pfizer COVID-19 Vaccine shots and boosters. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Itchy hives, swelling of face and eyes. Local reaction at injection site, raised area.
Patient has a 4 inch rash around the injection site and has been experiencing burning and itching along her arm and back.
Hospitalized for rehabilitation for stroke on 2/25/2022, woke on 3/5/2022 with headache, and sore throat and found to be COVID positive at that point. Required O2 that evening, started Remdesivir.
Unknown woman called on 7/30/21  to ask if we were vaccinating with "Covid shots approved by the government."  She later began to cry and stated that her father had passed away 1 day after receiving the vaccine at our location.  I asked her for her father's name, she identified him as the patient.  I vaccinated him on 7/28/21.  She said she indicated that the family was in touch with his primary care physician and would provide us with updates.  I will be in contact with his primary care provider on Monday, 8/2/21.
Within two minutes of receiving the shot I experienced left upper back pain. 1.5 hrs after receiving the shot I had extreme head congestion. My right hip started to hurt. Then I was freezing then sweating. The next day my whole entire body hurt. Every inch of it, my jaw, my fingers, my whole entire body. Extreme fatigue. That continued the following day also the congestion. Then the following day after that 8/18 I woke up with chest tightness and my whole body was weak my legs were very weak. Went to the ER and was told I was having a severe reaction to the vaccine. Rest and sleep for my body to recoup. 8/19 still congested legs and arms weak. That night at 10 pm my lower legs and feet were tingly pins and needles feeling. My hands did the same thing then started going numb. No strength. I saw my pcp on 8/20 and it?s a severe reaction to the vaccine. It?s affecting my nervous system my nerves are inflamed and was prescribed prednisone to help with the inflammation. 8/21 legs still weak. Still have the pins and needles feeling. Hands keep going numb.
Child went to mother's classroom after receiving shots. Fainted - fell backwards on head. Had only strawberry milk for breakfast. Just finished P.E. class - was hot sweaty. Mom stated was "out" about minute. Was awake, warm, clammy when I reached room. Mom took to M.D. later that day. Missed next day. School nurse reported child vomited - thought maybe virus rather than from head injury.
pt seen 2 1/2 wks p/given Td states that inject site became reddened & pruritic; 1 cm area of induration;
This spontaneous report as received from a licensed vocational nurse refers to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided. On 08-OCT-2018, the patient was vaccinated with a dose of improperly stored VARIVAX (lot # N034552 with expiration date 05-DEC-2019) (exact dose and route of administration were not provided),for prophylaxis. The VARIVAX was reconstituted with properly stored sterile diluent, (lot # and expiration date not reported). The VARIVAX experienced a temperature excursion of 15 degrees Fahrenheit to 46 degrees Fahrenheit for 12 hours. There was no previous temperature excursion. The digital data logger was involved in recording the temperature excursion details. No adverse effects were reported. This is one of two reports received from the same reporter (linked to case: #1810USA004911). Sender's Comments: US-009507513-1810USA004911: Original Case: 1810USA004911.
Pharmacist and manager of store, administered both vaccines on 10/19/2017. Patient developed a reaction 24 hours after the administration of the vaccines. He stated he went to see his doctor, who gave him steroid shots which seemingly stopped the severe reaction (hives, ichiness all over body, and throat closing). He stated the steroid shot didn't last long and the reaction started. His doctor phoned in an order for prednisone 20 mg tablets on 10/30/17 to stop the reaction. Employee did not notice any hives or swollen spots at the time of consultation on 10/30/17. Patient inquired if he should get the next dosage and employee referred him to consult his physician. (Note: patient had requested accelerated dosing schedule due to travel). He received one dosage thus far on 10/19/17.
in april 2021 i suddenly  came down with pain in legs and arms went to urgent care  the symptons are that of polymyaliga  and now on prednisone
feeling flushed,rash/SOB/anxiety/chest tightness BP-130/76,p=85 t-99.4 Narrative:
Severe pain in arm where injected, swelling. On 23 Jun AM jaw began to hurt, severe pain in arm, tingling and pain throughout hands and fingers of injected arm/ left arm, difficult to lift arm, severe pain with contact of injection site, still swollen.  On 24 Jun still unable to lift arm completely--loss of range of motion.  Unable to hold things, or lift even small objects with left hand/arm without significant pain. Still swollen, injection site is hot.
redness & swelling @ site w/soreness; vax given 25JUL95; rxn started 29JUL95; pt called MD & was told to take ASA & DPH & call back if no improvement;
Information has been received from a registered pharmacist concerning a 25 year old female nurse who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot # not reported).  Following the vaccination the nurse experienced "severe local pain" at the injection site.  It was noted that it was unknown if this was the first injection of the vaccine.  Unspecified medical attention was sought.  Additional information has been requested.
Patient called the pharmacy on 12-10-2021 to report that she was having itching and a rash formed.   She was advised to contact her prescriber if the symptoms got worse or changed.    She asked that we just note it in her file.   If symptoms did not improve in 24-48 hours she should see her doctor.   She did end up seeing 2 different prescribers at an Urgent Care facility and was provided prescription treatment.  On 12-13-2021 she was prescribed by HCP Zyrtec 10mg daily and Prednisone 40mg daily for 5 days.   She followed up with Dr. at the same Urgent Care on 12-20-2021 and was provided a Medrol DosePak and Atarax 25mg three times per day if needed for itching.
vomiting x5 episodes, fever (tmax 101), headache, myalgia
Immediately following vaccination my left foot started tingling. I didn't think anything of it at the time, but it keeps happening from time to time ever since i got the vaccine. I also experienced extreme fatigue and nausea for 48 hours following vaccination.
Information has been received from a nurse referring to a currently 17 year old male patient with penicillin allergy. The patient had no pertinent medical history. He did not take concomitant medication. On 22-JAN-2013, the patient was vaccinated with GARDASIL (lot# H019088, expiration date 26-JUN-2015) (strength and dose were not reported) intramuscularly for prophylaxis. On an unspecified date after 22-JAN-2013, the patient was diagnosed by an unspecified physician with "multiple lumps in his breast". The reporter did not know if treatment was given. The outcome of the event was unknown. The causality between GARDASIL and the event was unknown. Additional information has been requested.
2 weeks after the second vaccine developed a red, eczematous/psoriatic appearing rash on bilateral upper and lower extremities. No oozing, but there was a scale around the edges of the rash.
EDC03-29-2023, EGA 7 Weeks. EDD 12/18/2023 Pt came to clinic and requested Tdap and Varicella, vaccines.  Pt stated she is not pregnant when nurse asked her. staff nurse did not look back on Pt's charts, took Pt word. Previous visit on 04-24-2023, show she had done a pregnancy test and it was positive, no idea why Pt stated she was not pregnant at the time of visit on 05-01-2023.
Information has been received from a physician concerning a 15 month old female who on approximately 14-NOV-2006 was vaccinated with MMR II. Concomitant vaccinations included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid and influenza virus vaccine (unspecified). Subsequently, the patient experienced rubella rash all over the body, mostly on the trunk and a few on the face and was irritable after receiving the vaccine. The patient sought medical attention. Additional information has been requested.
Staff member had diarrhea, headache, pain in body and loss of taste and smell.
21AUg97 730PM t102.5, n/a, h/a;dec temp & ache w/APAP q 4hr;22AUg97 t100 no h/a, n/v;25AUG97 no s/s of illness;
PSORIATIC ARTHRITIS AGGRAVATED, INFLAMMATION, SKIN BREAKOUT; SINUS INFECTION; HAND OSTEOARTHRITIS; NODULE ON FINGER; MASS; ERYTHEMA OF EXTREMITIES, RED HANDS; GRIP STRENGTH DECREASED; THROAT INFECTION; This spontaneous report received from a patient via other company (Abbvie) concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: psoriatic arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number and expiry were not reported) dose was not reported, 1 total administered on 20-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers.  Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number and expiry were not reported) dose, frequency, and therapy dates were not reported for psoriatic arthritis. No concomitant medications were reported.  On an unspecified date, the patient experienced psoriatic arthritis aggravated, inflammation, skin breakout, sinus infection, hand osteoarthritis, nodule on finger, mass, erythema of extremities, red hands, grip strength decreased, and throat infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of adalimumab was not changed. The patient recovered from sinus infection, and throat infection, and had not recovered from psoriatic arthritis aggravated, inflammation, skin breakout, hand osteoarthritis, nodule on finger, mass, erythema of extremities, red hands, and grip strength decreased. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220320480-covid-19 vaccine ad26.cov2.s- Psoriatic arthritis aggravated.The event(s) has a unknown/unclear  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: MEDICAL HISTORY.This event(s) is considered not related.
(I received both Pfizer vaccines, but there was only room to report one. I received the first vaccine on 5/12/21 and felt sick for a few days. The details here will be about what happened after the second dose which I received on 6/2/21). The evening after getting the second dose of the Pfizer Covid 19 vaccine, I began to feel body aches and had a low fever. That persisted on and off for four days. The fatigue from that didn't seem to get better. As time went over over the next few weeks. I was sleeping a lot, with extreme muscle weakness. I normally exercise frequently and am a healthy adult, but it was extremely difficult to catch my breath when running, and I had trouble breathing when I was singing ( I could only sing a couple words before having to gasp for breath again). I made an appointment with my doc and she ordered blood tests. Before I could get those results, my health had declined to the point where I was taking several naps throughout the day, my muscles felt extremely weak, and joint pain (which I had never had before) was getting extreme. It was so bad I could barely walk in the morning, and my normal tennis days were impossible. I also had a bizarre stabbing pain in the top of my right foot. I began to wonder if I would be able to go back to work in the Fall (I'm a teacher). This was crazy! I'm a healthy adult woman with no health problems! I thought my life was over as I knew it. The results from my blood tests showed that I had possible lupus. I had full blood work done as part of a physical just before my vaccines and everything was normal. Out of desperation, I began a severe elimination diet to try to cut down on inflammation. (I've been a distance runner most of my adult life and was super scared my joints were getting damaged). Within a day of starting that diet (basically eating just meat), my joint pain went away. Later that month, one of the three lupus markers my doctor had tested for came back normal (the other two were still positive for possible lupus). The fatigue continued and is still present. I must take a nap daily, and leave work feeling like I can barely stay awake. I am still eating my super strict diet and as soon as I stray from it a little bit, the joint pain returns with a vengeance. I don't know how I'm going to return to a normal life. I have a rheumatolist appointment scheduled for January.
Pain is in the joint of his shoulder and arm; Pain is in the joint of his shoulder and arm; Pain in his neck; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the patient.  A 75-years-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 75 years as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "spine surgery" (unspecified if ongoing), notes: Caller reported he had spine surgery. The patient's concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious), PAIN IN EXTREMITY (non-serious), outcome "not recovered" and all described as "Pain is in the joint of his shoulder and arm"; NECK PAIN (non-serious), outcome "not recovered", described as "Pain in his neck". The events "pain is in the joint of his shoulder and arm", "pain is in the joint of his shoulder and arm" and "pain in his neck" were evaluated at the physician office visit.  Additional Information: Caller with dob 23Dec1945, stated he has had all 3 doses of the PFIZER COVID-19 vaccine. Caller did report pain in his neck and shoulder. Caller reported he had spine surgery. Caller reported the pain is in the joint of his shoulder and arm and has been going on for 8 months. Caller stated he took the booster dose and it got worse again but now it was better again, but it never goes away. Caller stated he sees a therapist. Caller stated he told the therapist at the beginning of therapy his pain was a 10. Caller stated his last appointment was today and his pain is now 1-2. Caller wanted to know if other people have reported pain in the shoulder after the vaccines. Caller asked how long does it last and is it going to go away. Caller asked could it be nerve issue.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
BP down to 60/40 immed p/vax then passed out when got to car (upset about vax); 31JUL 3 days p/vax was seen by MD for t103 & h/a & numbness rt arm;
Currently have knot on left arm at injection site with slight rash and itching that began approximately 7 days after receiving vaccine
pt started with migraine the night of the vaccine.  then three days later developed tingling in left leg that gradually went up her left back/side, arm, then into her face and lip.  all tingling have now resolved except for constant tingling in left arm; pt has similar reaction to a flu shot 10 years ago.
Monovalent Pfizer vaccine given instead of Bivalent. Product similarity including BOTH having gray caps. Writing SO small hard to discern difference. Vials so small labeling is almost impossible without covering barcode / LOT#. VERY DISAPPOINTED that FDA would allow look-a-like sound alike that Pfizer is producing. Expiration date is actually manufacture date. This breaks EVERY rule we have been instilled to watch for. Would appreciate correspondence as to the reasoning for allowing this.
Vaccine was diluted and in the vial stored at room temperature for 7 hours and then administered to a patient; Vaccine was diluted and in the vial stored at room temperature for 7 hours and then administered to a patient; nausea; dizziness; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team.  A 12 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 26Oct2021 16:00 (Lot number: FH8020, Expiration Date: 31Jan2022) at the age of 12 years as dose 1, 0.3 ml single for covid-19 immunisation. Relevant medical history included: "Generalized anxiety disorder" (unspecified if ongoing), notes: Verbatim: Generalized anxiety disorder; "Migraine" (unspecified if ongoing), notes: Verbatim: Migraine. There were no concomitant medications. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious) all with onset 26Oct2021 16:00, outcome "unknown" and all described as "Vaccine was diluted and in the vial stored at room temperature for 7 hours and then administered to a patient"; NAUSEA (non-serious) with onset 26Oct2021, outcome "recovered" (26Oct2021), described as "nausea"; DIZZINESS (non-serious) with onset 26Oct2021, outcome "recovered" (26Oct2021), described as "dizziness".  Additional information: The reporter stated that 12-year-old male patient received vaccine which was diluted and in the vial stored at room temperature for 7 hours and then administered to a patient, the vaccine was mixed, and it was out for over 6 hours. The vaccine was actually out for 7 hours instead. The vaccine was expired at 3PM and instead was given at 4PM. Caller states that the vaccine was diluted and was in the vial stored at room temperature for 7 hours and then administered to a patient. Caller asks if the patient needs to be revaccinated or for any recommendations or monitoring. No investigation assessment. The patient did complain of dizziness and nausea at the 15-minute mark, and there were no other reactions. Caller clarified that this event happened today and this was the first dose for the patient. The dizziness and nausea resolved, both only lasted for about a couple of minutes. The patient has no drug allergies.  Follow-up attempts are completed. No further information is expected.
No additional adverse effect reported.; a male Patient received improperly stored M-M-R II; This spontaneous report as received from a medical assistant refers to a 5-year-old male patient. The patient's pertinent medical history, drug reactions and allergies and concomitant medications were not reported.   On 24-OCT-2019, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose and frequency were not reported) lot # R031680, expiration date 01-NOV-2020. The vaccine was reconstituted with properly stored sterile diluent. No adverse effects were reported. The call was because of data logger, with a temperature excursion of -58 degrees Fahrenheit (F) and +46 F (19.13 F) for 1.5 hours. There was a previous temperature excursion reported with a temperature above 47 F (54.93 F) for 15 minutes, -58 F and +46 F for 12 hours and 15 minutes.
Fever, Body Aches, Headache, chills and nausea started at 10pm on 1/4/2021. Patient was seen in office on 1/5/2020. Patient was sent home to rest and advised to take tylenol
1st dose Dec2020,late for 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose received in December 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 30-Aug-2022 Reporter's Comments: The pharmacist reported on 29th August 2022 that a female patient was late for the second dose of Shingrix.  The first dose was administrated in December 2020.  No adverse event was reported. The reporter was consented to follow up. The first dose was administrated on another facility No LOT number and expiration date provided. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.