chrisvoncsefalvay/vaers-outcomes huggingface dataset:
upset stomach; This case was reported by a consumer via call center representative and described the occurrence of upset stomach in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included cancer.   On 25th April 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a week after receiving Shingrix, the patient experienced upset stomach. On an unknown date, the outcome of the upset stomach was unknown.   It was unknown if the reporter considered the upset stomach to be related to Shingrix.  Additional details were provided as follows: In 2019, the patient experienced upset stomach. The reporter gave consent to follow up.
Patient fainted when standing to leave pharmacy after receiving vaccine.  Patient did wait suggested time of 15 minutes after receiving vaccine.
Dizziness: This started a few weeks after the vaccines and lasted for about 4 months.  I would have dizziness randomly throughout the day. It felt like my balance was off. I still suffer from dizziness although it is not as often. I am an otherwise healthy person. Menstrual Pain: I had several weeks of extreme menstrual pain, it felt like cramping, although I had a hysterectomy in November 2020. I still have my ovaries. The pain was more intense than the hysterectomy recovery.
p/vax pt devel a dime sized purple lesion approx 1 inch from the inj site;the next day pt devel an area of inflammation around the inj site the size of a baseball which persisted as of 10/30/98;pt declined to provide further info;
Coronary artery disease - weight loss, arterial hypertension, diabetes, loss of muscular, Insomnia. 02/19/2007 Reporter spoke with someone. Stated onset of AE was 02/2005.  02/27/2007 MR received from VA.  Frequent office visit from 05/05/2004 to 12/2006, most frequently with cardiology clinic and primary care.  D/C summary also sent for hospitalization in Oct 2004 for c/o chest pain. Patient reported almost daily chest pain (10/05/2004) for the prior 2 months associated with SOB.  Admitted for cardiac cath.  and percutaneous angioplasty.  DX: Single vessel CAD  S/P PCI.  Initial office visit 5/5/2004 to establish care.  Review of Systems (+) for weight loss, rashes, headaches, visual changes, cough, yellowish sputum, diarrhea, myalgias, memory changes. PE (+) erythematous lesions on chest, abdomen, back, and thighs. Otherwise WNL. Assessment:  HBP Stage 2, Tinea corporis, cervical and lumbar stenosis, Rt. nephrolithiasis, Elevated liver enzymes, URTI.  Multiple F/U visits with the following Assesssments: GERD, Tension Headaches, CAD, Essential Hypertension, Erythema Annulare Centrifugum,  Prostatitis, Low back pain, Depression, sleep disturbances,  Angina pectoris,  Uncontrolled hypertension,  Atypical chest pain, tension headaches, Impaired fasting glucose, and.Slowing of urinary stream.
Soreness everywhere; Chills; fever; Constant belching; Joint pain; Nausea; Constipation; A spontaneous report was received from a (Consumer) concerning a- 71 years old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Soreness everywhere, chills, fever, constant belching, constipation, joint pain and nausea. The patient's medical history not reported. No relevant concomitant medications were reported.   On 22 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch:013M20A) unknown route and site for prophylaxis of COVID-19 infection. On 21 Feb 2021, the patient experienced Soreness everywhere, chills, fever, constant belching, constipation, joint pain and nausea. Laboratory details not provided. Treatment was taken as Advil and diazepam. Action taken with mRNA-1273 in response to the events was not reported.  At the time of this report, the outcome of the events were Not Recovered/ Not Resolving.
L arm v, warm, firm & swollen.  Not painful to touch.  To use cool compresses & take ibuprofen.
Mother states (L) anterior thigh red and swollen, hot to touch. Dr prescribed abx for cellulitis.
I experience periods, when I should be in menopause. It lasted for about 6 months after the vaccine. I went to my OBYN doctor about this. They did an endometroid biopsy, negative results. They thought it might be from the vaccination.
Went emergency after noticing one of my veins had turned red and was hardening.  Vein pulsing in left leg.  Emergency room doctor diagnosed "superficial thrombophlebitis."  The pulsing in lower leg (calf) continues and in elbow and wrist joints. The pain is not an issue.  I've been feeling a bit of but most of my discomfort has been anxiety about what's going to happen next and what are the throbbing.  The vein is no longer red, is slightly hard, pain is a 1 on scale of 10.  Doctors have not contacted me since the evening after I was seen and I reported to them I felt better than I did at the hospital.
Developed rash on Sunday and Monday 3/14/  turned into full shingles outbreak on left chest and under left arm and now back
Large welt type lump at the location of the shot on the back of arm.  Present for 3+weeks now.  Gets bigger and smaller, painful to the pt when touched.  3 weeks after vaccine administration, pt developed mild case of chicken pox on body (stomach, back, etc).  Also had viral like symptoms such as mild fever and fatigue.
Nausea started a few days after my second dose. I contacted my PCP . He recommended doing COVID test, which I did at the  Hospital - results were negative. I have ruled out diet as a source of nausea by fasting  (significantly lower food intake than usual).  Stopped drinking tea, which aggravated nausea symptoms. The symptoms persist after 3 weeks! Nausea is strong in the morning, and little better as day goes buy.  I never had this problem in past decade or so, therefore I believe its the vaccine that's doing this.
ear buzzing like a mini tornado or hurricane wind sound/ right ear sounded like it had a motor running in it. It was a loud humming in his ear; dry mouth; This is a spontaneous report from a contactable consumer (Patient).    A 79-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: unknown), dose 1 via an unspecified route of administration on 25Jan2021 as single dose for covid-19 immunisation. Medical history included excessive cerumen production and cerumen removal. The patient's concomitant medications were not reported. Caller stated he wanted to report side effects for the first dose of the Pfizer vaccine he got on the 25Jan2021, He said when he wakes up his "ear buzzing like a mini tornado or hurricane" wind sound. it usually goes away after few hours, it has been happening in the morning. On 26Jan2021, he also has dry mouth, had never experienced something like this before. Then, yesterday morning on 28Jan2021, at 3 am, his right ear sounded like it had a motor running in it. It was a loud humming in his ear. It eventually went away before he got up.This morning, he had the same thing at about 4-430 am. He turned over and his ear had like a mild roaring. It sounded like a motor running. It was like a rushing sound. It went away by this morning. He didn't have a prescribing doctor. The dry mouth wasn't a solid 12 hours.It comes at odd times. Patient understood mouth breathing could cause dry mouth, but he isn't breathing from his mouth. He is normal breathing. His mouth is dry and has to keep drinking water. Sometimes later on in the day it is randomly dry. He has never noticed anything like this in his entire life. When he rolled over in his sleep, he could hear a rushing in his right ear.He had wax in his ear before, and the nurse would pop a ball of wax out that was blocking his ear, but this noise isn't anything like that. Patient never had this noise before. In his 70 some years he has never had ear problems. The outcome of the event tinnitus was not recovered and dry mouth was recovering. Information about Lot/Batch number is requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Flu shot administered let deltoid region intramuscularly on 10/22/15. 2 hours after shot, client came back at Health Center complaining of pain left arm, feeling "faint and hot". Vital signs taken - 90/70-92-18 (sitting) 100/80-94-20 (standing). Tylenol and cold packs given. Reported incident to Dr.
Hives; itchy; feeling sick; This case was reported by a pharmacist via call center representative and described the occurrence of hives in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In March 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced hives, pruritus and feeling unwell. On an unknown date, the outcome of the hives, pruritus and feeling unwell were unknown.   It was unknown if the reporter considered the hives, pruritus and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The patient experienced big hive on his arm, which was itchy and felt sick. No additional details were provided.
Approx. 35 hours after admin of vaccine, client states he had developed hives and swelling over this arms and face, he stated he took BENADRYL and IB and these symptoms resolved. He did not seek any medical attention. No difficulty breathing or SOB.
the pain traveled from beneath my rib, up my left side to my armpit; the pain traveled from beneath my rib, up my left side to my armpit; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Crohn's Disease" (unspecified if ongoing); "ileostomy" (unspecified if ongoing); "pain was similar to shingles pain" (unspecified if ongoing), notes: 24 years ago, doctor put me on Acyclovir and a muscle  relaxant; "Food allergy" (unspecified if ongoing); "Levaquin allergy" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D3; MULTIVITAMINUM. Vaccination history included: Bnt162b2 (1st dose, EN6203, vaccine location:Left arm, Administration time:08:45Am), administration date: 06Mar2021, for Covid-19 Immunization, reaction(s): "sharp pain under my left lower rib". The following information was reported: MUSCULOSKELETAL CHEST PAIN (non-serious), outcome "not recovered", AXILLARY PAIN (non-serious), outcome "unknown" and all described as "the pain traveled from beneath my rib, up my left side to my armpit". The event "the pain traveled from beneath my rib, up my left side to my armpit" and "the pain traveled from beneath my rib, up my left side to my armpit" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
After he got the second shot, he had shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6204, Expiry date: Unknown), via an unspecified route of administration, administered in right arm on 11Mar2021 (at the age of 78 years) as dose 2, single for COVID-19 immunization. Medical history included chronic obstructive pulmonary disease (COPD) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9264, Expiry date: Unknown) via an unspecified route of administration, administered in right arm on 30Jan2021 (at the age of 78 years) and experienced tested positive for COVID-19 on an unknown date in Feb2021. The patient experienced shortness of breath on an unknown date in Mar2021. As reported clinical course as, after he got the second shot, he had shortness of breath, but he had a history of COPD, so he was not so worried about that. He got the vaccine because he tested positive for COVID. He tested negative a couple of times, but then he went and got checked and it said positive. He was testing negative for COVID before getting the first dose of the vaccine, but he went to rehab and was tested, and tested positive for COVID in Feb2021. He left rehab on 11Mar2021, and he went that same day to go get his second dose of the product. The patient underwent lab tests and procedures which included sars-cov-2 test: positive in Feb2021. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
My daughter started her menstrual cycle on January of 2021, with regular periods barely any cramping.  Since taking vaccine she has had severe menstrual cramps along with heavy bleeding and vomiting, this is the second month since vaccination that she is experiencing these painful cramps.
MISSED THE SECOND DOSE OF VIVOTIF; This spontaneous case report was received from a consumer (PVX2019-209) on 22-Jan-2019. The report describes a 72-year-old male consumer who "missed the second dose of Vivotif". The consumer was receiving oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  It was reported that the consumer took the first dose of Vivotif on Friday and missed his second dose which was due on Sunday.  The action taken with Vivotif with respect to the event "missed the second dose of Vivotif" was not applicable.  The clinical outcome of the event "missed the second dose of Vivotif" was unknown.  Company's Comment: The causality of the event "missed the second dose of Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed the second dose of Vivotif" was considered as not applicable.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age and gender. On 09-JAN-2014 the patient was vaccinated with GARDASIL (dose and route not reported, lot # 1073AA, expiration date 11-OCT-2013). There was no concomitant medication reported. The nurse reported that the patient was administered an expired dose of GARDASIL. No adverse effects reported. Additional information has been requested.
Inconsolable crying for 24 hours, eyes rolled back to head. Listlessness (unable to eat food but still nursed).
necrosis of arm tissue; This spontaneous report was received from a pharmacy technician referring to a 61-year-old female patient. The patient's concurrent conditions included asthma, fibromyalgia and arthritis. The patient's medical history included depression, lethargy, suicidal ideation, indifference and off label use. She had no known drug allergies. the patient's historical drugs included propranolol. The patient's concomitant therapies included etodolac, pregabalin, escitalopram, tramadol, pantoprazole, atorvastatin, levothyroxine, potassium, furosemide, estradiol, trazodone, montelukast and primidone.  On an unknown date in September 2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and influenza vaccine (FLU) for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not reported).  On an unknown date in October 2020, the patient experienced necrosis of arm tissue (soft tissue necrosis). The outcome of soft tissue necrosis was unknown.  The causal relationship between the vaccines and soft tissue necrosis was unknown.   Upon internal review, the event soft tissue necrosis was determined to be medically significant.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient became lightheaded and passed out shortly after receving vaccine. Was able to get patient to lay on floor before he temporarily lost consciousness.  Emergency services responded and examined patient on site. He was able to get up and walk out later.  Patient said he did not really eat anything today and felt like sugar was low.
Headache, Myalgia, NauseaVomiting, fever-100.3 F had two days of leave, rest at home
several hrs p/receiving Typhoid/Cholera vax, simultaneously, pt was brought to clinic in  "a state of collapse"; sx presented were paleness, fever & chills; pt treated in ER;
pt recvd vax & 36 hrs following 3rd dose pt exp local red swollen react; also exp body aches w/generalized edema & swelling;
Injection site became very big and large bruise, patient stated it itched, and that she had a rash with very small red bumps that did not itch.
Bad allergic reaction above her eye; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the parent.  A 16 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "cancer" (unspecified if ongoing), notes: She is undergoing chemotherapy for her cancer.; "allergic to peanuts" (unspecified if ongoing), notes: she is allergic to peanuts. The patient's concomitant medications were not reported. The following information was reported: EYE ALLERGY (non-serious), outcome "unknown", described as "Bad allergic reaction above her eye". Therapeutic measures were taken as a result of eye allergy.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
screaming w/extreme irritability throughout the noc p/vax;seen in ER the following AM for marked irritability & t104 R;
Information has been received from a consumer concerning his daughter (age not given) who a month ago (exact date not reported), was vaccinated (route and site not reported) with Hib conj vaccine (OMPC) (lot # not reported).  The patient's father reported that a day after receiving the vaccine the patient developed a high fever and could not breathe.  The patient was admitted to the hospital and stayed there for 2 weeks.  The father reported that the patient now has to do many treatments for breathing.  The patient's father did not want to answer any other questions and disconnected from the phone call.  At the time of reporting the patient's outcome was not reported.  Additional information has been requested.
ended up in the hospital with a collapsed lung; This serious case was reported by a consumer via interactive digital media and described the occurrence of collapse of lung in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE for prophylaxis.   The patient's past medical history included shingles (The patient experienced the excruciating pain of shingles in 2019), pain (The pain was so debilitating) and blistery rash (blistering rash on her abdomen was incredibly painful It felt like thousands of tiny needles constantly burning and pricking her).   On an unknown date, the patient received Shingrix and INFLUENZA VACCINE. On an unknown date, an unknown time after receiving Shingrix and an unknown time after receiving INFLUENZA VACCINE, the patient experienced collapse of lung (Verbatim: ended up in the hospital with a collapsed lung) (serious criteria hospitalization and GSK medically significant).  The outcome of the collapse of lung was not reported.   The reporter considered the collapse of lung to be possibly related to Shingrix.     The company considered the collapse of lung to be possibly related to Shingrix.   Additional Information: GSK Receipt Date: 23-SEP-2023 The reporter's sister took Shingrix vaccine along with the Flu shot and landed in the hospital with a collapsed lung. Emergency room doctor said stop taking multiple vaccines at a time. The patient should not receive Shingrix if they were allergic to any of its ingredients or had an allergic reaction to a previous dose of Shingrix. The reporter think that the event might have been related to the Product/Device. Follow-up was not possible as no contact details were available. The company considered the collapse of lung to be possibly related to Influenza vaccine.
Phone call from mom got Imms (HIB and PVNR) 3-23-09. On 3-25 had a seizure in the car. He had been drinking a bottle, began shaking, and choking and turned blue. Mom was already pulling off at a rest stop, and it turns out that there was an EMT there by chance, who performed some degree of CPR, then ambulance came and took child to hospital. There he had normal blood work and head CT, but had ear infection. No fever. This is all per mom's verbal hx. No fam hx seizures.
Person giving the injection gave it in the back of my arm, almost as if she was giving a sq injection. They used the 1in needle so I think she got into my tricep but it was nowhere near my deltoid. I have injection site soreness which is why I think she even got to the muscle but I have none of the classic immune reaction symptoms. I wanted it on record in case it was not thoroughly absorbed and then I wouldn't be covered. I figured with this being so new every mistake matters. I'm going to try and get an antigen test in 2-3 weeks.
Stool has become clay like texture; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ABNORMAL FAECES (Stool has become clay like texture) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-May-2021, the patient experienced ABNORMAL FAECES (Stool has become clay like texture). At the time of the report, ABNORMAL FAECES (Stool has become clay like texture) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
After receiving a HEP A injection pt walked to front desk & ran into the exit door.  She stated "every thing was purple because the shot hurt so much.  Checked by physician afterward - BP 100/70 observed for 20 min.  Mom warned to take child to ER if H/A extreme sleepiness slurred speech etc
Patient presented 10/7/18 to ER and clinic 10/9/18 with flu-like symptoms and left arm redness/swelling.
Second dose: Fever:  105 F. for 14 hours Headached 14 hours Sore, swaloow, stiff and red arm
Shoulder severe pain and severe weakness following pneumococcal vaccine injection provided high into the deltoid muscle. I Hypothesize that vaccine injected into  subdeltoid bursa caused a periarticular inflammatory response, subacromial bursitis, bicipital tendonitis and adhesive capsulitis. I am disable to fully use my right arm because the deltoid muscle can not pull my arm without a extremelly and severe pain. I conclude that the upper third of the deltoid muscle should not be used for vaccine injections. I was at my primary physician office who concurs. The same day the injection was applied I called the facility and request information, they suggested to go to the emergency room. I declined that because I do not want to expend another 12 hours waiting for medical care. I was there on Thursday August 7th at 6:30 p.m. and I was interviewed by the physician the following day at 7:30 a.m. then I was transfer at 9:00 am until Sunday August 10th. 2008 That day the vaccine PPV was applied, and my problem started. Today's date 08/12/2008 I was at my primary physician. I explained everything. Based on that intramuscular injection of vitamin 12 with steroids was applied. I do not know jet if this would help me with my disable arm. 9/10/08-records received-8/25/08-presented with C/O injury to left 4th toe.