chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Difficulty breathing; Puffed up; Medical history incudes allergy to sucrose; This case was reported by a physician via call center representative and described the occurrence of difficulty breathing in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included allergy (patient had allergy to sucrose on unknown date).   In September 2019, the patient received the 1st dose of Shingrix. In September 2019, unknown after receiving Shingrix, the patient experienced documented hypersensitivity to administered product. On an unknown date, the patient experienced difficulty breathing and swelling. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the difficulty breathing and swelling were recovered/resolved and the outcome of the documented hypersensitivity to administered product was unknown.   It was unknown if the reporter considered the difficulty breathing and swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccinated with 1st dose of Shingri from healthcare provider. After an unknown amount of time following the vaccine the patient stated he puffed up and began to had difficulty breathing, self treated with Benadryl and self administering nebulizer treatments. The events were resolved without seeking medical help. The patients medical history incudes allergy to sucrose but sucrose is listed as an ingredient in the Shingrix vaccine which led to documented hypersensitivity to administered product. The reporter consent to follow up.
Almost immediate swelling at injection site, blotchy red rash with complaints of itching. Doctor was notified, 25mg liquid benadryl administered, glass of water. Vitals remained stable. No other S/S of allergy developed. Improvement within 3-5 minutes. S/S resolved by the time patient left the clinic 25 min later.
c-diff; salmonella; Gastrointestinal problems for 35 years but it was manageable. However, about after a week or two after his 2nd Pfizer vaccine, he got a whole lot worse; Gastrointestinal problems for 35 years but it was manageable. However, about after a week or two after his 2nd Pfizer vaccine, he got a whole lot worse; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "he's had gastrointestinal problems for 35 years" (ongoing), notes: he's had gastrointestinal problems for 35 years but it was manageable. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: 2021, for Covid-19 immunization. The following information was reported: CLOSTRIDIUM DIFFICILE INFECTION (medically significant), outcome "not recovered", described as "c-diff"; SALMONELLOSIS (medically significant), outcome "not recovered", described as "salmonella"; GASTROINTESTINAL DISORDER (medically significant), CONDITION AGGRAVATED (medically significant), outcome "not recovered" and all described as "Gastrointestinal problems for 35 years but it was manageable. However, about after a week or two after his 2nd Pfizer vaccine, he got a whole lot worse". Clinical Course: Patient stated he took "the 2 Pfizer vaccines in '21" and mentioned he's had gastrointestinal problems for 35 years but it was manageable. However, about after a week or two after his 2nd Pfizer vaccine, he got a whole lot worse. He said he got salmonella, c-diff, which were mild cases but persistent and he's been sick basically for the last 2 and a half years so he's had some reemissions.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient reports her and her husband both having pain in the arm where injected with the vaccination for extended period of time (3 weeks).
Around midnight on the day of the vaccination I started having chills and needed to dress more warmly and throw on an extra quilt in order to get warm. Slept through the night without any other event. Got up very early the following morning @ 4:30 and continued with chills and body aches.  Chills and aches continued the rest of the day as well as loss of appetite.  Late evening the chills subsided. Today, April 7, just feeling a little tired. Chills gone, muscle aches lessened. This is similar to my previous reactions to my second vaccination and first booster shots. This was my second booster and the symptoms were a little more intense.
Unable to speak directly with case. Case was admitted to hospital and tested positive on 04/22/2022. Currently she remains hospitalized.
Medication Administration Error- After receiving her second dose (Vaccine Lot # ER8727), being observed (with no reaction) she returned home. It was at this time she self reported to the clinic that she had thought her appointment was for 3/19/2021,  it was in fact scheduled for 3/26/2021. Client received her first dose on 3/5/2021 (Vaccine Lot #EN6203). This resulted in Client receiving her second dose outside of the established guidelines for the acceptable duration between doses by 2 days (15 vs. 17-21). Client did not report any adverse reaction or problems.  A new software update may have had a part in staff missing that Client was returning early. Staff at all levels have been re-educated on the importance of checking and rechecking returning appointment times and dates
Extremely tired (slept most of the next two days after the vaccine), felt like had fever, and had to increase oxygen. Sore arm, very sore to the touch.
Narrative: COVID infection following COVID vaccine series 03/11, Pfizer, dose #1 04/01, Pfizer, dose #2 10/26, Pfizer, dose #2 10/25 COVID swab, result: detected 10/25 pt cc: exposure: unknown
I had been attending physical and occupational therapy for 1 month before my 2nd Covid booster shot.  In late April I began to have stiffness in left arm and numbness of the left index and middle fingers.  In reviewing progress notes, my OT identified that two problems were first noted at the first session following this 2nd booster.  That is I reported no difficulty in these during a dozen previous sessions but began having them right after the booster.  The winging scapula was confirmed by a neurologist on 7.22.22 who also tested and diagnosed carpel tunnel syndrome.  PT and OT treatments continue 2-3 times per week.
ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY 4/22/2023 DM 2 CONTROLLED BY DIET
Saturday night headache took Tylenol, Sunday body aches chills headache dizzy nauseous weak, Monday vomiting headache dizzy heart palpitations body aches, Tuesday continued headache body aches
Local redness, itching, tenderness to right arm. Red blotches on arms and chest. Benadryl 25mg tablet given.
Information has been received from a healthcare worker referring to various unspecified patients. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 03-MAY-2015, doses of VARIVAX (lot # L040421 with expiration date of 15-OCT-2017; lot # L040423 with expiration date of 15-OCT-2017 and lot # L043623 with expiration date of 02-NOV-2017 (lot # L043623 is an invalid lot number for VARIVAX), dose frequency and route unknown) were exposed to a temperature excursion at 0.2 degrees Celsius for 4.5 hours and back in range then. Subsequently the vaccines were exposed at minus 4.9 degrees Celsius for 1 hour and 42 minutes and back in range after that. Since 03-MAY-2016, the vaccines were administered to unspecified patients. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Left arm pain, fever, body aches and headaches. 10 x 12 cm red, tender area over left deltoid. T. 102, No flu shot test available to rule out flu.
Information has been received from a physician concerning a 17 year old female patient who a few months ago, was vaccinated intramuscularly, with the first 0.5ml dose of GARDASIL and the doctor had her remain in the office for 20 minutes. When the patient got home she had shortness of breath. The patient called the doctor that night (It was also reported that the patient did not seek medical attention). No treatment was required. Therapy with GARDASIL was discontinued. On an unspecified date, the patient recovered from this event. Additional information is not expected.
About 20 minutes after patient received the vaccine her face appeared red and blotchy. Patient stated itching all over her body and itching in the mouth. Patient was advised to go to emergency department (ED) at Hospital, 1.5 blocks away from the store. Pharmacy staff contacted patient about a half hour later and patient stated that she was in the ED being checked out.
Experienced severe headache for a full day. Took ibuprofen but it only provided partial relief. Then tinnitus began and has not gone away. It has intensified, along with worsening vertigo, throbbing headache across different parts of my head, and neck pain. I spend most free time in bed now because I get dizzy. I feel like my brain is inflamed. It is maddening.
Shortness of breath, tight chest, chest pain, low-grade fever, swelling in the hands arms feet legs and face, body aches all over, felt like muscles were tightening in the entire body.
This spontaneous report was received from a Registered nurse regarding a 10 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 02-AUG-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1804USA005153:
Diarrhea; My whole body hurts; my whole back hurts; My whole body hurts; my whole back hurts; I can't breath very well; shortness of breath; not been able to sleep; sweat; headaches; chills; Muscle ache; chest tightening; fever; 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 59 year-old male patient received bnt162b2 (BNT162B2), administration date 31Jul2021 13:30 (Lot number: FA7485) at the age of 59 years as dose 1, single for covid-19 immunisation. Relevant medical history included Covid-19, start date: Jan2021 (unspecified if ongoing), in January2021. There were no concomitant medications. The following information was reported DYSPNOEA (non-serious) with onset 31Jul2021, outcome not recovered; INSOMNIA (non-serious) with onset 31Jul2021, outcome not recovered; HYPERHIDROSIS (non-serious) with onset 31Jul2021, outcome not recovered; HEADACHE (non-serious) with onset 31Jul2021, outcome not recovered; CHILLS (non-serious) with onset 31Jul2021, outcome not recovered; MYALGIA (non-serious) with onset 31Jul2021, outcome not recovered; CHEST DISCOMFORT (non-serious) with onset 31Jul2021, outcome not recovered; PYREXIA (non-serious) with onset 31Jul2021, outcome not recovered; DIARRHOEA (non-serious), outcome unknown; PAIN (non-serious), BACK PAIN (non-serious), outcome unknown; DYSPNOEA (non-serious) with onset 31Jul2021, outcome not recovered. Therapeutic measures were taken as a result of headache, pyrexia.  Additional info- It was reported that patient  took the 1st dose of the Pfizer COVID vaccine two days ago, later in call confirmed to 31Jul2021, and he can't sleep, zero, like he may get 30 minutes of sleep and then he gets up for 2 hours. He also woke up in a pool of sweat this morning, like his body, his head, shorts and shirt were all completely soaked. He has massive, massive headaches, his chest feels like something is pushing on his chest, he has chills and he has a fever. He doesn't know what he can take or what to do. He had COVID in Jan2021 and this is 10 times worse than what he had and he had a pretty bad case. Patient also had a query he could take aspirin for fever and headache because Tylenol for fever and headache, it's killing him.  No follow-up attempts are possible. No further information is expected.
Administered with less than optimal dose (0.45 mL); A spontaneous report was received from pharmacist concerning a 66-years old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273), and who experienced incomplete dose administered.   The patient's medical history was not provided. No relevant concomitant medications were reported.   The patient received their first of two planned doses of mRNA-1273 on 5 Jan 2021 (Lot number 039K20-2A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. During the administration, the pharmacist did not push the plunger correctly all the way, and the patient did not receive the full dose. After measuring what was left in the barrel of the syringe, they estimated that the patient received only 0.45 mL of the vaccine instead of 0.5 ml.  No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The event, incomplete dose administered, was considered resolved on 5 Jan 2021.; Reporter's Comments: This is a report of 66-year-old female patient, who was administered less than optimal dose (0.45 mL) (incomplete dose administered) mRNA-1273, lot # 039K20-2A. There were no reported adverse events associated with this case of incomplete dose administered
chills, night sweats, body aches, fatigue, low grade fever, sore throat
On 12-26-2020, I woke up feeling weak, very dizzy and dragged down. I felt generalized malaise, headaches, body aches,. I worked a 12 hour shift, was pale. I had alot of more weakness through my body and was very nauseated and had loss of appetite. On 12-29-2020,  I felt a heaviness to my chest, extreme pain with rapid heart beat, I had elevated blood pressure, had numbness to my face and hands (pins and needle sensation) .  The day after 12-30-2020 I was seen lower extremity weakness and visible muscle spasms in my knees and legs. I had a hard time ambulating and I was weak for another week. I had shortness of breath and had difficulty going up the stairs.  I went home that same day when they ruled out it was not a cardiac event.
5-6 hours after vaccine-mild muscle aches, temperature elevated but above 100.  About 8 hours after injection, muscle ached and so was chilled but felt ok otherwise.  FitBit alerted me that I was earning points for being in my ?active zone? even though I was just watching tv - resting heart rate is 66   (actively exercising, heart rate  is usually less than 120) but it was 136+.  HR stayed elevated ( Verified HR with pulse oximeter) while I was not  doing anything. Took temperature (forehead thermometer) and it was 103F.  Took Tylenol. Heart rate slowly went down after Tylenol kicked in and fever came down to 101.  Heart rate stayed a little higher than normal and fever lasted 24 hours. By 48 hours, all was well.
Pt called at 9:15am on 1/6/18 to report experiencing chills/shakiness around 11pm the evening of 1/5/18 and muscle aches upon waking up on 1/6/18. She did not report having attempted any treatment. I advised her to take either acetaminophen or ibuprofen to treat the achiness and to follow-up with either urgent care (this weekend) or her regular physician (Monday) if there was no improvement in the next day or two.
Information has been received from a healthcare professional concerning a 2-month-old male, with no pertinent medical history or allergies, who on 25-FEB-2008 was vaccinated orally with his first dose of ROTATEQ (lot # 659708/1621U). Concomitant vaccines included PEDIATRIX, PREVNAR and ACTHIB. On 25-FEB-2008, post vaccination, the patient experienced diarrhea, vomiting and fever. The patient's mother sought medical attention via a call to the physician. Two months later during an office visit with the physician the patient had fully recovered, but the second dose of ROTATEQ was not given. No diagnostic labs were performed. A product quality complaint was not involved.  Additional information is not expected.
CHIEF COMPLAINT Syncope   HISTORY OF PRESENT ILLNESS Patient is a 74 y.o. female who has a medical history of type 2 diabetes mellitus for which she is on insulin, heart failure preserved ejection fraction, coronary artery disease, asthma, chronic stasis dermatitis, CKD stage III/4, MGUS, CVA with left-sided weakness, atrial fibrillation not on anticoagulation, obstructive sleep apnea, osteoporosis and rheumatoid arthritis for which he is being followed by rheumatology and is currently taking prednisone, leflunomide, hydroxychloroquine, and Abatacept. She initially presented to the ED the morning of 10/23 for evaluation of 1 day of cough and fever, COVID swab was positive.  She is vaccinated
Severe pain and stiffness in arm near injection site. Unable to lift arm and unable to get comfortable due to severe pain.
Approximately 11 hours post-injection, general tiredness crept over me.  Decided to call it a night early and before I could get in bed, the chills and shaking began.  This continued for approximately 4 hours.  I was thirsty and struggled to get up and get water, as I was getting weak and unsure of my stance.  No fever, but headache and general joint aching began around midnight.  Sleep was practically nonexistent.  Got out of bed around 7 a.m. to eat and take acetaminophen for headache.  Also prepared and started pushing electrolyte sports fluids (drink tabs).  Ate a piece of toast with jelly and could not taste it.  Had lost my sense of taste.  Went back to bed for my first of 2 morning naps.  After my second nap, approximately 11:00 a.m., most of the symptoms had abated although I was still weak.  Had oatmeal with protein powder (standard breakfast for me) and more electrolytes.  Recovery was rapid and by 3:00 p.m., all symptoms except loss of taste had resolved.  Taste finally return the next day.
Severe soreness in left shoulder (injection site) resulting in inability to use arm (per patient).  Suggested treatment over the counter with Ibuprofen, and a doctor visit, if no relief.
Information has been received from a registered nurse and the consumer a 41 year old white female with hypertension, sulfonamide allergy, drug hypersensitivity to codeine and acetaminophen (+) Vicodin and a history of mumps and chicken pox twice (initial case was mild, second case in 6th grade) no history of immunocompromise who on 14 Sep 2006 at 11:00 am was preparing a dose of Proquad (Lot # 653463/0463F) and the rubber stopper "blew off " the vial and the solution splashed into her eye. Previous therapy included 1 dose of Proquad. Concomitant therapy included blood pressure medication (therapy unspecified). The eye was flushed with running water and a saline solution. She initially experienced burning in the affected eye with erythema and edema of the eyelids, no discharge but this gradually improved. Debris from the vial did not enter the patient's eyes. The patient was seen by an ophthalmologist who further irrigated and cleaned her eyes. The patient was seen at 1:40pm and diagnosed with conjunctivitis. The patient received medication to numb her eyes and was prescribed Tobradex. No laboratory diagnostic tests were performed. A product quality complaint was involved. Follow up information from the consumer, who was also the administering health care professional indicated that when she was injecting the diluent into the vaccine vial, the vaccine and diluent exploded causing the stopper on the vaccine vial to shift and the hub of the syringe blew from needle. The vaccine then went into her eyes. The glass did not break. The patient recovered on 15 Sep 2006. Additional information is not expected.
This spontaneous report as received from an office manager refers to a patient of unknown age and gender. Medical history was not reported. The patient was vaccinated with the first, second and third dose of GARDASIL route intramuscular, (dosage, lot numbers and expiration dates were not reported), on 24-JUN-2008, 15-DEC-2008 and 28-JAN-2009 respectively. No adverse effect was reported. Additional information has been requested.
Buzzing/ringing in head.  Tinnitis??  Was intermittent but is not constant. getting worse as time goes on.
Hospitalization 3/14 to 4/21 with sepsis and hickman line infection. Admitted again from clinic 4/8/21 with worsening shortness of breath and progressive leg swelling  with abdominal distension. Has not had any issues with chronic diseases prior that required hospitalizations
MILD PAIN IN LEFT LEG; RIGHT ARM WAS SORE WHERE HE GOT THE VACCINE; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies, had no bad medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 on right arm for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced right arm was sore where he got the vaccine. On 02-APR-2021, the subject experienced mild pain in left leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from mild pain in left leg, and right arm was sore where he got the vaccine. This report was non-serious.
Arm s feel weak; Feels feverish; Head hurts; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Arm s feel weak), PYREXIA (Feels feverish) and HEADACHE (Head hurts) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced MUSCULAR WEAKNESS (Arm s feel weak), PYREXIA (Feels feverish) and HEADACHE (Head hurts). At the time of the report, MUSCULAR WEAKNESS (Arm s feel weak), PYREXIA (Feels feverish) and HEADACHE (Head hurts) outcome was unknown.            Concomitant medications were not reported. Treatment information was not reported.
Subsequent to receiving one dose of varicella virus vaccine live the pt experienced a strong case of chickenpox with a lot of spots.
Pt started feeling ill within a few hours of the vaccinations. She went to bed early due to just not feeling good all over. She woke up in the middle of the night and had a temp of 103 and felt very dizzy. She even awoke her husband to have her get some washcloths to cool her down. The next morning she felt the same, but at about the 24 hour mark for imz, she felt better.
Patient collapsed on her way to the bathroom about 24 hours after taking the vaccine and could not move for about 30 mins after passing out. This happened again...and then her caregiver had to accompany her for every bathroom visit. The patient's daily activities were quite limited for the next 5 days.....easily exhausted, felt dizzy, disoriented and brain fog....