chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fatigue; sore arm; low grade fever; shortness of breath; This is a spontaneous report from a non-contactable consumer or other non hcp. A 32-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: unknown), dose 2 via an unspecified route of administration, administered in arm left on 30Apr2021 at 10:00 (at the age of 32-years-old) as dose 2, single for covid-19 immunisation. Patient medical history included drug hypersensitivity. The patient was allergic to Amoxicillin and ceclor. Concomitant medication included vitamin c [ascorbic acid], multivitamins [vitamins nos], biotin, quetiapine fumarate (SEROQUEL) and vilazodone hydrochloride (VIIBRYD). Patient historical vaccine included received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration on 09Apr2021 at 10:00 for covid-19 immunization. It was unknown if the patient was covid prior vaccination. On 30Apr2021 at 12:00, the patient experienced fatigue, sore arm, low grade fever and shortness of breath. Patient did not test for covid post vaccination. Facility where the most recent COVID-19 vaccine was administered was a pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Device date was provided as 01May2021. Outcome of the events were recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report was received from a pharmacist via field representative regarding to a male patient of unknown age. The patient's concurrent conditions, historical conditions, past drug and concomitant medications were unknown. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (lot#, expiration date, route and dose were unknown). On an unknown date the patient experienced pain and tenderness at the injection site and was feeling sick (malaise). The outcome of injection site pain and malaise was unknown. The causality of events was not reported.
Starting 12/22/21 (five days after vaccine was given), I experience 8 days of concerning fatigue, moderate appetite loss, intermittent headaches, rapid resting pulse (80-110), and intermittent elevated blood pressure.
This spontaneous report was received from a nurse refers to a 4 months old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 05-SEP-2017, the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) (lot # M044397, expiry date: 20-JUN-2018) orally for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007014: US-009507513-1709USA007011: US-009507513-1709USA007012: US-009507513-1709USA007013: US-009507513-1709USA000054.
throat tightness; This is a spontaneous report from a non-contactable other hcp. A 60-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Lot number not provided), dose #2, intramuscularly in the right deltoid on an unspecified date (at an unspecified age) as a single dose for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (lot number: EK9231), dose #1, via an unspecified route of administration on an unspecified date as a single dose for COVID-19 vaccination. On an unspecified date, the patient was given vaccination dose #2 in the right deltoid muscle. During her 15 minute waiting period following the injection, the patient began to experience throat tightness. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. Therapeutic measures taken as a result of the event was antihistamines and bendadryl. Folllow-up response to treatment: no side effects. The patient was assessed as stable to go home and was discharged. The clinical outcome of the throat tightness was unknown.   No follow-up attempts are possible. No further information is expected. Information about lot/batch number cannot be obtained.
pt recvd vax; devel fever of 102, chills, h/a; 25jan94 had n, v, diarrhea, weakness w/in 24 hrs of vax lasting for 2 days; tx w/ apap;
The patient's right hand swelled up, including pain. This is on the opposite side of the injection site.
Contracted covid-19 . Symptoms (fever, chills, body aches, headache) from 4/19 thru 4/24
pain at time of injection. felt like hit the bone. that evening began having sharp nerve pain radiating down arm when I moved arm or hand certain ways . that persisted until I saw dr Nov 6 for a different issue. told him about arm, he agreed it was from inmmunization injection. He did a treatment on arm with some relief but pain returned . it continues to cause shooting pain, sometimes aching of deltoid, weakness. He did another treatment today with short term relief.
This spontaneous report as received from a physician via a field representative refers to a 12 years old female patient. On approximately 24-OCT-2012, "yesterday or today", the patient was vaccinated with the third shot of 0.5 ml GARDASIL. No other co-suspects were reported. No concomitant medications were reported. The doctor told him that the patient received her third GARDASIL shot, and then was asked to stay seated before leaving to make sure she was okay. The patient's mother told the doctor that this wasn't necessary because the patient had no problems when she got the first 2 shots. As she was walking out through the waiting room, the patient passed out. As a treatment, the office staff sat her down and gave her water until she recovered and could leave on the same day the shot was given. It was reported that the adverse event occurred after reintroduction. Additional information has been requested.
This spontaneous report was received from a 60-year-old female nurse, who was reporting on herself. The patient stated she had no pertinent medical history, however she admitted having a big history of allergies (not otherwise specified). On 23-MAR-2017, the patient received a dose of ZOSTAVAX vial (exact dose, lot # and expiry date were not reported) together with diluent (exact dose, lot # and expiry date were not reported), subcutaneously for prophylaxis. Concomitant therapies included hydrochlorothiazide (reported as "HCTZ") and unspecified estrogen replacement therapy. On the same day, the patient developed raised area at injection site and generalized itching. Following day, she started an unspecified antihistamine treatment. Then, on 26-MAR-2017, the patient experienced shortness of breath and throat tightening which was treated with prednisone (manufacturer unknown). The patient had no lab diagnostics studies performed. The outcome of the events and causality between the event and suspect therapies were not reported. Upon internal review, the events of shortness of breath and throat tightening were considered to be medically significant as they appear to be part of the clinical presentation of an allergic reaction which required medical intervention given by treatment with prednisone (manufacturer unknown) to prevent from jeopardizing the patient. Additional information has been requested.
Moderna - became flu like, treated for pneumonia like symptoms for appx one week, Covid rash developed appx two weeks after the injection.
Pt having induration 64 x 64 mm. having redness mom notice yesterday afternoon. Pt not complaining any pain or itchiness.
4 days after vaccine administration developed nausea and diarrhea, followed by joint pains/swelling and macular rash
Information has been received on 14-MAY-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In 2014, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, at a pharmacy. The inoculation was recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended. Rather the patient contracted a persistent strain of herpes zoster. On or about 01-JUN-2016, the patient was treated at an urgent care for the onset of a rash and was diagnosed as herpes zoster or shingles. As a direct and proximate result of the defective ZOSTAVAX, and/or as a result of the tenuous efficacy of the vaccine, the patient suffered painful injuries and damages, and required extensive medical care and treatment. Further, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On 18-NOV-2015 the patient was vaccinated with oral, ROTATEQ (lot # L008057, expiration date 01-DEC-2016, dose not reported), which was exposed to temperatures outside of the recommended temperature (incorrect product storage). No adverse experience had been reported. This is one of several reports received from the same source. Additional information has been requested.
Super sore/painful arm upper; painful to move; worse than sore arm from sleeping wrong.   Started around 4 hours after being poked. General bad feeling; rundown. Slight headache; all over head, but that was probably highlighted by the fact I've been trying to change my sleep schedule.  99.8 fever
Swelling and tenderness almost immediately at injection site on day of vaccination, 01/20/2023. Pain until Day 5 after vaccination.  Noticed splotches on that arm that spread to other arm. Did not see our provider until Thursday 02/02/2023 when she had trouble breathing and then saw our provider at this clinic.  Pain, and swelling went down . Today the skin is flaking off on both armas and not painful. It does itch at times.
Redness, swelling & itching around the injection site on the left anterolateral arm. Area of erythema and induration at office visit on 5/11/2015 was 10 cm x 8 cm.
This spontaneous prospective pregnancy report was received from a physician via a company representative and refers to a female patient of unknown age. No information regarding the patient's medical history, concomitant therapies and concurrent conditions was provided. On 05-DEC-2018, the pregnant patient was vaccinated with a dose of GARDASIL 9 (dose, frequency, route of administration, lot # and expiration was not reported) for prophylaxis. The reporter stated, that the medical assistant had intended to give the patient the "flu shot", but inadvertently gave GARDASIL 9. The date of last menstrual period (LMP), date of conception and estimated date of delivery (EDD) were not know and could not be calculated. The pregnancy outcome was pending. The outcome of the events and the causality assessment was not provided.; Sender's Comments: US-009507513-1812USA004514:
Patient received a Moderna COVID-19 Vaccine First Dose. The vaccination site is unknown and was not collected from the patient during there admission. The Lot number, etc were also not collected. This report is being placed by the treating facility and not the vaccination site and is being done after discharge. Patient had acute onset left sided numbness at 12:30pm while she was under her 15min observation post-covid19 vaccine injection. The patient reported that the numbness initially started in her left cheek that spread to the left side of her head then down her left side of the body reaching her toes. Patient was evaluated for stroke and according to the treating physician, the neuro exam was normal and patient answered appropriately for feeling touch or degree of touch equally bilaterally. NIHSS was 0 and MRI showed no acute CVA. The blood sugar was in the 50s with EMS. According to the treating physician, the symptoms may be related to the hypoglycemia at the same time as the incident. The physician also reports that the patient was very anxious in general and at times stated she had numbness that was worsening but at other times was witnessed walking around the room and to the bathroom by nursing staff without need for assistance or deficits. The patient was kept for observation and discharged the day after admission. A reaction to the vaccine cannot be completely ruled out considering the onset of symptoms but there may be other causes. The patient was asked to report this to the vaccination site prior to receiving the 2nd dose and be cleared by her PCP for the 2nd dose. This report is being entered in a abundance of caution in the setting of this new vaccine.
possible rxn to anthrax shot;had sz 5 days post vax w/cold/flu sx preceding sz;episode occurred 0800AM 7MAR;
pretty intense pain; limited ROM; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   In March 2022, the patient received Meningococcal B vaccine. In March 2022, less than a week after receiving Meningococcal B vaccine, the patient experienced pain and mobility decreased. On an unknown date, the outcome of the pain and mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the pain and mobility decreased to be related to Meningococcal B vaccine.     Additional Information: GSK Receipt Date: 28-MAR-2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The patient received meningococcal B 1 week prior to the reporting.  The shot was very painful and had pretty intense pain ever since with limited range of motion. The patient asked what to be done now. Additional Supportive Information:  The follow-up would not possible as no contact details were available.
Ras on right inner thigh, and hives. Treated with liquid BENADRY, called in epi pen jr. Appointment with the allergist.
At approximately 6 PM on 05/23/2021, family was sitting down for dinner when all of a sudden she noticed that he was turning his head to the left and appeared to be falling out of his chair.  Mom states that eyes were darting back and forth at this time.  He was not responding to her shouting his name and his left arm was curled in towards his body with the rest of his body remaining stiff.  This lasted approximately 1 minute, followed by a time of confusion and drowsiness.  Approximately 1 minute later mom states that patient's eyes rolled back to his head and he had full body movement consistent with tonic-clonic seizures.  Family were able to lay him onto the ground during this time.  Mom denies any color change, apnea, or loss of bowel or bladder.  States he did have one episode of emesis following the event, and 2 episodes of emesis in the ambulance on the way to ED.  Patient has no previous history of seizures or seizure-like activity.  No new ingestions.  Has not been sick recently and denies any new sick contacts.  There has been no head trauma.   Per Mom, patient's dad has a history of "partial seizures" but never required any medication for them.   At arrival to the ED he continued to be drowsy and not at his normal baseline.  Continue to hold his left wrist up toward his body in a contracted manner and tended to have repetitive speech.   Briefly, ER course significant for a CT head and evaluation by pediatric neurology.  CT head was unremarkable for acute intracranial process.  A CBC, CMP, and coags were also obtained due to patient's continued contracture positioning and the possibility of a stroke.  CMP was unremarkable with a sodium of 139, potassium of 3.7, chloride of 107, bicarb 25, BUN of 12 and creatinine of 0.64.  CBC was also unremarkable with WBC of 10.72, hemoglobin of 14.8, hematocrit of 44.4 and platelets of 370.  There was 81.77% neutrophils after evaluation by neurology it was felt that the patient remained postictal and recommended that he be admitted on continuous EEG and possible MRI in the a.m.
On 04-24-2021 I had four days of extreme headaches that would not go away so I went to the ER where I got checked out. Also on 03-28-2021, I woke up with extreme left leg pain. I had difficulty holding things with my arms and I almost collapsed to the floor due to my left leg pain and weakness. I also had heavy menstrual bleeding with giant clots for the Month of March 2021.  I can say today I have no symptoms of my left leg or headaches today.
Pt reports menstrual cycle was very regular up until the second dose of the Pfizer COVID vaccine on 5/13/21. Cycles were every 4 weeks, lasting 4-5 days. Next period was due at the end of May.  Following the May vaccination she has had a total of 3 cycles in the last 7 months. One cycle at the end of June, one at the end of October and one at the end of December. All 3 have been longer in duration, more painful.  Each month when her period should be starting she experiences cramping in the legs and lower abdomen, fatigue.
Systemic: Fainting/Unresponsive-Severe, Systemic: Flushed/Sweating-Severe, Systemic: Vomiting-Medium, Additional Details: Patient fainted after receiving COVID-19 vaccine and Fluzone Quadrivalent vaccine (batch/lot#UT7411LA) concurrently. Paramedics called. Patient vitals checked in the store. Patient left unassisted approximately 30 minutes after the incident.
Pt began wheezing 15 mins after his Flu shot. He used his inhaler and wheezing resolved.
Large (60 mm local reaction, induration, warm with distal, paraethesia of ulnar nerve. Symptoms developed approx 48 hours after vaccination. Vaccination site over tricep (L) UE.
onset of fever 14OCT92-105-fever gone 18OCT; rash 19OCT x 2 days;
itchiness at the injection site; swelling at the injection site; Initial information was received on 26-Aug-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves female patient (20-30 years) who had itchiness at the injection site (vaccination site pruritus) and swelling at the injection site (vaccination site swelling), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient was not pregnant. She had no concomitant medications.   On an unknown date, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UJ432AB, Expiry date: 30-Jun-2021, form: Pre-filled syringes) once via unknown route in the deltoid NOS for prophylactic vaccination.  On an unknown date, the patient developed a non-serious itchiness at the injection site (vaccination site pruritus) and swelling at the injection site (vaccination site swelling) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  No laboratory data was reported.  The patient was treated with INFLUENZA VACCINE (Flu seasonal vaccine).  At the time of report, the outcome of events was unknown.
Arm, legs, head, (fell body) tremors, unable to walk, stand, woke after a nap (2 hours) went to get up and fell to the floor "Brain felt mussy" 11/10/11 felt much better tremors gone 11/11/11 no tremors (LO) - warm, sore.
My first shot was on 1-13-2021 at 7pm. By the morning of 1/14/2021, my arm was extremely sore. I was experiencing severe pain in all my muscles and severe joint pain. By the third day, the pain in my knee kept me form bending it. I could only sit in a lounge chair and not function. Pain every where, from shoulders, arms, legs down to my feet. Horrible. By the end of a week, the severe pain had been reduced to aches. My aches and pains continued on. A call to my doctor encouraged me to get the second shot, in spite of the side effects that the first shot produced My second shot was on 2-11-2021 The results of this shot again brought on severe pain to my upper body arms, muscles and shoulders. It is now 4-16-2021 and I am still trying to cope with the pain in my arms, muscle, and shoulders. My arms are very weak, It is necessary to take 2 Tylenol pills every four hours in order to function. through the day and night. I have a slight problem with my back. This vaccine intensived the problem.  I also have a knee problem in one knee. Two weeks prior to my vaccine, I had received a cortisone shot and the knee was doing fine. until I received the vaccine. It is painful to function now, and I am unable to receive another cortisone shot. until June  This vaccine has brought me more grief. I will never go for a third booster shot nor once a year.  I am 85 years old, and did not need this nightmare. I also have the total care of my 91 year old husband who has cancer, along with 3 other medical problems.    It would be nice if someone can tell me how long my symptoms will last. It was easier dealing with being confined to my home for 13 months, than dealing with all these problems from the vaccine.  I wrote this letter to inform you that there ARE problems with the Moderna vaccine, as I am a prime example of one.  I guess I can be grateful that it didn't kill me.
Pfizer vaccine was administered outside of the clinic - reported by patient   ACUTE RESPIRATORY FAILURE 6/17/2021 NONTRAUMATIC INTRACRANIAL HEMORRHAGE, UNSPECIFIED  ACUTE RESPIRATORY FAILURE 6/17/2021 CAD (CORONARY ARTERY DISEASE) WO ANGINA
experienced symptoms afterwards like a flu; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A female patient in her 60's received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer" ), administration date: Dec2021, for COVID-19 immunization. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "experienced symptoms afterwards like a flu". Additional Information: The reporter stated that the patient and her family received the 2 doses of the vaccine back in Dec and they already got the booster dose. Caller said that she is the only one who experienced symptoms afterwards like a flu. She would like to know if there are any cases with girls' periods being affected.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.