chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 12-Oct-2018 regarding an unsolicited valid non-serious case received from Other Health Care Professional. This case involves a four-years old male patient who received 2 IPV doses; one with IPOL lot NIG511 via unknown route in unknown administration site and one as part of KINRIX not produced by Sanofi Pasteur lot number not reported via unknown administration site on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included VARICELLA ZOSTER VACCINE for Immunisation. It was a case of actual medication error due to extra dose administered. It was not reported if the patient experienced any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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. List of documents held by sender: none.
"Breakthrough event" - contracted severe COVID symptoms on March 17, 2023. Symptoms mirrored that of early variant reports and severe symptoms. Paxlovid prescription called-in to pharmacy after telemedicine visit. Shown to be effective and a turning point in illness. Have been unable to contract trace source of infection. Work from home and do not have frequent contact with others other than when running errands or exercising outdoors. Significant other works in a hospital but never tested positive.
HE GOT RASH ON HIS FACE (APPROX 6-8 SPOTS) AND CAME BACK TO PHARMACY TO PURCHASE BENADRLY. PATIENT EDUCATION CONDUCTED.
Injection site redness...more than 5 days. Arm soreness has decreased daily.     Initial noticed effect besides slight soreness in arm... Chills 10 to 11 hours after injection. These increased for next 12 hours.    Weakness, moderate to severe nausea( vomiting).. lasted 2 days. Not able to keep food down. Headaches...slight to moderate migraine headache..3 days..in duration...decreasing in severity daily.  On second night and third night.....profuse sweating on Second night....restless and little sleep. Third night slight sweats in early morning.      After 4 days....eating and getting energy back from a really bad experience.
Localized knot developed at injection site--palpable, non tender or hot to touch.
Rash on groin began one week after receiving vaccine. Rash and hives spread over entire body except neck, face, hands, and feet. No other symptoms (fever, dizziness, or shortness of breath), just a VERY itchy rash on body. After 3rd day, a doctor via telephone appointment stated I had yeast infections in my groin and armpits and eczema on other parts of my body; she prescribed Triamcinolone 0.5% Cream for the eczema. I used the cream for a day or two and did not improve. I saw another doctor in-person two days later, she did not know what it was and just prescribed OTC hydrocortisone cream and referred me to a dermatologist. I saw a dermatologist the next day and she advised that it was a reaction to the Pfzier booster I received the week earlier. She prescribed Hydroxyz Hcl 10 Mg Tab Kvkt and Prednisone 10 Mg Tablet. I am currently on my fifth day of medication and am seeing a slow progress in the rash. I still have hives on my body but they are flat now instead of raised; they are still itchy at times but the topical ointments have helped.
12/19/2020 MORNING WOKE UP AT 4PM FOR WORK, HAD HIVES ALL OVER EXTREMITIES AND TRUNK. WENT TO URGENT CARE; PRESCRIBED MENTHOPREDNISONE. TAKING THE PREDNISONE AND ZYRTEC SINCE THAT DATE.  *HX 5-6 MONTHS OF HIVES.  CONSULTING WITH ALLERGIST. SEEN 12/21/2020.
On the night of 12/19/21 (12 days after the booster), I began experiencing full body hives that came on with extreme intensity and left me unable to sleep for hours. These symptoms have persisted with varying intensity for roughly a month now (I'm typing this on January 18). On most days, I am recording multiple bouts of hives. Itching will often begin in the palms of my hands or around my neck/head, followed by hives and itching all over my body, frequently on my upper back, belly, and legs. I was unable to sleep last night, even with the assistance of over-the-counter antihistamines. I've been taking Benadryl and putting hydrocortisone cream on the affected areas. It slows the hives somewhat, but not enough to prevent extreme discomfort and itching. This is having an extremely deleterious effect on my daily life.
Patient was due for Day 7 vaccine on 8/24/2020 and she came into the health department today on 8/26/2020; This case was reported by a nurse via other manufacturer and described the occurrence of drug dose administration interval too long in a female patient who received Rabies NVS (RabAvert) for prophylaxis.   Concomitant products included Rabies NVS (RabAvert) and Rabies NVS (RabAvert).   On 26th August 2020, the patient received the 3rd dose of RabAvert. On 26th August 2020, unknown after receiving RabAvert, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were reported as follows: The age at vaccination was not reported. The patient received RabAvert vaccination for post exposure prophylaxis. The patient was due for Day 7 vaccine on 24th August 2020 and she came into the health department on 26th August 2020 for the vaccination hence nurse asked how to proceed with the dosing schedule. The reporter stated that for most minor deviations from the schedule, vaccinations could be resumed as though the patient were on schedule. For example, if a patient missed the dose scheduled for day 7 and presents for vaccination on day 10, the day 7 dose should be administered on day 10 and the schedule resumed, maintaining the same interval between doses. In this scenario, the remaining doses would be administered on days 17 and 31. The patient received 3rd dose of RabAvert, later than the recommended interval, which led to lengthtening of vaccination schedule.   On the follow up/following internal review it was determined that the initial receipt date (26th August 2020) which is earliar than initially reported.
Left foot and leg started swelling and continued swelling. Got to the point it got extremely painful. I went to the doctor. Sent me for Ultrasound, no clot was found. At first the compression socks helped completely but over time it has decreased in it's help; the compression socks are keeping the pain somewhat at bay now. Vein Specialist November the 5th.
Extremely sick; Affected neurological; Increased pain in fibro; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on the right arm on 21Apr2021 (10:30) as a 1st dose, single dose, with route of administration unspecified, for COVID-19 immunization. Medical history included fibromyalgia; complex regional pain syndrome (CRPS); small fiber neuropathy; brain lesions; thrombocytopenia; chronic arthritis; nerve damage in elbows and hands; tree nut allergy; shellfish allergy; and allergy to lots of medications. The patient was not pregnant at the time of vaccination. Concomitant medication included lisdexamfetamine mesilate (VYVANSE). On 12May2021, the patient was extremely sick; affected neurological; and had increased pain in "fibro". The events had resulted into doctor or other healthcare professional office/clinical visit. The patient had received prednisone, diphenhydramine (BENADRYL) and epinephrine as treatment for the events. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested for COVID-19 since the vaccination.  Information on the lot/batch number has been requested. Additional information has been requested.
6 days after vaccine I had fever, nausea, headache, stiff neck, fatigue.  Symptoms lasted 2 days and are improving.
BP 132/86 Ct. began to experience numbness approx. 10 minutes in (Lt.) arm after receiving TD vaccination - numbness extended to (Lt.) elbow  - into shoulder area and radiating to (Lt.) side of back - no complaints of breathing difficulty - no throat tightening or rash - referred immediately to M.D.
I had a patient come in at 10:05am for a Moderna Covid vaccine. Just before 11am we received a call from the patient's roommate that the patient arrived home and collapsed, it was also mentioned her blood pressure was high. We explained that they needed to call 911 but the patient did not want to go to the hospital. We explained that this patient must go to the hospital and get evaluated. They did end up calling 911.  Approximately 45 minutes later I received another call from the patient's roommate that EMS did not believe this was a reaction from the vaccine. The roommate mentioned that she was in fact mistaken about the blood pressure and it was actually low (92/54 mmHg). She also mentioned that the patient was vomiting.   Around 1:45pm I received a call from the roommate to tell me that the patient had died.
I was achy and had a headache. I took some ALEVE and was advised to lay down and get some rest and drink plenty of water. I remained achy and sick for 2 days and then after this time I was ok. I do feel that I have completely recovered but I am recovering from a separate illness.
Case completed Covid vaccine series in March 2021, then was hospitalized for Covid, then died of Covid in September
Per dermatologist,  diagnosed with Folliculitis- sterile foliculer based vaccine reaction to smallpox, well described. Patient had asymptomatic red spots on upper trunk 9-10 days after small pox and anthrax shot.
pt recvd vax;c/o bilateral lower back pain x 2 mo;pale & dyspneic;loss of appetite x 2 wks;weight loss;tests revealed inc bilirubin 2.6,HGB dec 8.1;HCT dec 23.5;platelets dec 13,000,ESR inc 55;WBC WNL 7.9;was hospitalized;
Rapid, irregular heartbeat - atrial fibrillation -continued after getting up in am - heart rate 155 bpm.  Visit to urgent care center, referred to Hospital.  Medically reduced heart rate, cardio conversion needed to convert back to normal rhythm.  Spent 36 hours in ED and CCU units of hospital.  Many tests, labs, xrays, electrocardiograms completed to assess heart normalcy. 11/2/09:  Hospital Records and Discharge Summary received for dates of service 10/25/09 to 10/26/09.  Dx:  Atrial fibrillation with rapid ventricular rate. Assessment:  Presented with 14 hour hx. of palpitations prior to admission.  Found in A.fib with a rate of 150.  Started on Lovenox and a Cardizem drip and her rate quickly improved while she maintained A. fib.  No hx. of heart disease.  Received H1N1 vaccine 4 hrs. prior to onset of sx.  Successfully cardioverted on 10/26/09 and discharged home on Aspirin. ICD 9 Codes:  427.31, 493.90.
pt devel numbness on rt side of body 24 hrs p/flu vax/DT/Meningococcal vax; pt was hospitalized due to adverse effect & was noted to be improving w/numbness currently localized to the rt leg;
Chills; Fever; I threw up; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6199 FHN 6-21 not clarified further), via an unspecified route of administration on an unspecified date as single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was calling to report a few side effects from the first shot patient had. When probed for the side effects, patient stated, "patient had chills, fever, threw up and diarrhea on an unspecified date. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient had first Gardasil, and arm still has a persistent swelling/lump, and is still sore.  Does not look like an infection.
arm was very sore; felt under the weather; Feel sort of crappy day after booster; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN IN EXTREMITY (arm was very sore), MALAISE (felt under the weather) and FEELING ABNORMAL (Feel sort of crappy day after booster) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm was very sore), MALAISE (felt under the weather) and FEELING ABNORMAL (Feel sort of crappy day after booster). At the time of the report, PAIN IN EXTREMITY (arm was very sore), MALAISE (felt under the weather) and FEELING ABNORMAL (Feel sort of crappy day after booster) outcome was unknown.            No concomitant medications were reported.   No treatment details were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-660538.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-660538:case for another patient-
5DEC91 t101.8 AX APAP poss rash-APAP, clear 330PM liquids, tepid bath; 6DEC91 1010AM 101 ax, red raised rash on stomach chest & back; no itching, vomiting; office vist needed;
She has had 5 or 6 shots she can not remember / I also am doing an AE because she may have had 6 vaccinations; Extra dose administered; No adverse event; This spontaneous case was reported by a patient and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (She has had 5 or 6 shots she can not remember / I also am doing an AE because she may have had 6 vaccinations), EXTRA DOSE ADMINISTERED (Extra dose administered) and NO ADVERSE EVENT (No adverse event) in an elderly female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Concurrent medical conditions included Immunocompromised.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (She has had 5 or 6 shots she can not remember / I also am doing an AE because she may have had 6 vaccinations), EXTRA DOSE ADMINISTERED (Extra dose administered) and NO ADVERSE EVENT (No adverse event). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (She has had 5 or 6 shots she can not remember / I also am doing an AE because she may have had 6 vaccinations), EXTRA DOSE ADMINISTERED (Extra dose administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (She has had 5 or 6 shots she can not remember / I also am doing an AE because she may have had 6 vaccinations) and EXTRA DOSE ADMINISTERED (Extra dose administered).    No concomitant medication were reported.  Patient wanted to know if she should get another vaccine. Patient wanted to know if the information concerning the CDC had updated or if the covid vaccine would be like the flu vaccine Patient had 5 or 6 shots, could not remember. No treatment information was provided by the reporter.
large bump under the arm pit; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY MASS (large bump under the arm pit) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced AXILLARY MASS (large bump under the arm pit). At the time of the report, AXILLARY MASS (large bump under the arm pit) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Medications were not provided by the reporter. Treatment Medications were not provided by the reporter.
ROTATEQ vaccine given 2/18/14. On 2/21/14, patient developed vomiting and diarrhea. On 2/22/14, patient diagnosed with intussusception and pt advised surgical correction at hospital.
Mom called on 4/23/01 to report a pinpoint, red rash over entire bilateral hands and bilateral feet, now extending up to knees on day 2. Mom says that it is already improving.
The patient had sensitivity to touch 11/9 at 10PM, red spots 11/10 AM spreading from shoulders progressively down to thighs, front and back; it felt like sunburn. On 11/10 in the PM the doctor advised antihistamine every 4 hours, he slept poorly. Began to fade 11/14.
Patient went completely white, head went down and his cell phone that he was holding fell to the ground. We asked him multiple times, Sir, are you okay? With no response. We immediately called ED.
"feels so sick\never felt this way in my life'\ She has flu symptoms; cold symptoms; getting hot and cold; freezing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single), for COVID-19 immunization. The following information was reported: INFLUENZA (non-serious), outcome "unknown", described as ""feels so sick\never felt this way in my life'\ She has flu symptoms"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "cold symptoms"; BODY TEMPERATURE FLUCTUATION (non-serious), outcome "unknown", described as "getting hot and cold"; FEELING COLD (non-serious), outcome "unknown", described as "freezing".  Additional information: reporter received the second dose of the vaccine. She stated she feels so sick, never felt this way in my life. She has flu symptoms, it feels like cold symptoms, she's getting hot and cold, and is freezing.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
i have 6 anthrax/booster shots.  (30Jun03, 25Sep03, 9Oct03, 30Mar04, 30Jan07, 1Aug07)  since my first anthrax shot, my upper right arm periodically hardens, bumps up, and itches badly.  it happens several times a month and is almost constant during the hotter times of year. it has lasted up to 2 weeks at a time.
34-year-old male with a PMH of GERD recently found to have COVID-19 on an outpatient test presents with right-sided back pain with inspiration and coughing, who was found to have new onset diabetes with hyperglycemia. Patient was complaining of a hoarse throat and generally not feeling well for about 1 week PTA. He took a COVID-19 test which was positive. About 4 hours PTA he developed sharp right sided back pain with inspiration prompting his visit to the ED. He does admit to polyuria and polydipsia the last several weeks.
I had a breakthrough case of Covid-19 it started with fever and chills I then became achy short of breath and had a headache I was nauseous. I was prescribed Paxlovid.
I have alopecia/ all but disappeared; This is a spontaneous report from a contactable consumer (reported for himself) via a Pfizer sponsored program. A 75-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: E69267), via intramuscular, administered in Arm Left on 06Feb2021 13:30 as DOSE 1, SINGLE and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6206), intramuscular, administered in Arm Left on 09Mar2021 07:00 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced he have alopecia, all but disappeared. Patient reported that in Feb and Mar he had the Pfizer COVID-19 vaccine. Did very well with both. Patient have little hair anywhere. After the COVID shots his eyebrows and eyelashes began to fill in very nicely. After a few weeks after the shots, it went the other way gain and have all but disappeared. Do you think this can possibly be related. Nothing else has been done different during this time, meds. etc. Patient would like to hear from us. This was not a complaint. Just wanted to know, if something in the vaccine affected his immune system that caused his hair to start regrowth his eye brows, eye lashes and a little chest hair were affected. Though may be something extraordinary was happened. It has since gone the other way. The clinical outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.
Mixed series--patient received Pfizer for first dose and Moderna for second.  No AE.
pt recv vax 7APR97 & 3 days later pt c/o red, swollen, warm arm;dx of cellulitis;given med;
Patient presented to pharmacy on 6/1/21 and stated hives that developed over his body, mainly arms, chest, abdomen, and back within a few hours/later that day from receiving vaccine.  Patient has been treating with topical hydrocortisone cream and as needed oral Benadryl under the direction of his PCP.  On 6/2/21 in the afternoon, patient stated they were starting to go away.
mild swelling erythema to rt arm close to inj site;warm to touch;next morning p/vax Dicloxcillin
Left shoulder pain, varying in intensity. Loss of rage of motion, discomfort while sitting/sleeping. Shooting pain when arm is lifted. Pain and discomfort runs to elbow and left shoulder blade.  After 3 days I lost range of motion in my neck for approximately 48 hours
pt recvd flu vax 26NOV90 & 16 days later devel t103.6; 26DEC90 had backache; later was mentally confused w/slurred speech; pt taken to hosp had grand mal sz, swelling of brain, severe dementia, behavior problems, delusions, hallucinations;
presented to the ER on 12/4/2021 with shortness of breath, fever to 101 at home, hypoxic to 83% at home. Wife recovered from COVID-19. Has dry cough Patient was admitted for worsening shortness of breath after positive COVID-19 test, was found to have acute hypoxemic respiratory failure.  Patient was treated with remdesivir and dexamethasone initially, chest x-ray showed potential consolidative process concern for bacteria superinfection as such levofloxacin was started.  Patient initially required increasing oxygen supplementation up to 6 L however by day 5 of admission was improving in terms of oxygenation.  On the day of discharge she was saturating mid 90s on 4 L nasal cannula and had experienced significant symptomatic improvement of symptoms.  Patient finished 5 days of remdesivir and will continue 5 additional days of dexamethasone and levofloxacin as outpatient.  Patient will follow up with primary care to ensure continued improvement and resolution of Covid symptoms and to wean off of oxygen as outpatient.
Had one episode of vomiting (3 times  consecutively) with no other symptoms. All symptoms resolved after episode. Patient stated she ate leftovers one hour before reaction. Feels normal today.