chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial misuse report received from a healthcare professional on 21 February 2014. A 56-year-old patient had received FLUZONE HD, (batch  number, dose and anatomical site of administration not reported) which is indicated for the use in patients with >65 years. No adverse event was reported. List of documents held by sender: None.
Unknown if patient experienced intestinal or diarrhea things; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received dose 1 of bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient experienced unknown if patient experienced intestinal or diarrhea things on an unspecified date. Reporter wanted to know if any adverse effect lets say three months or something like that after receiving the second dose of Pfizer as far as any kind of intestinal information diarrhea things like that had any severe symptoms like that. The clinical outcome for the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Pt received Tdap vaccine to LD at 1054 and was advised to remain in the store for 15-minutes following administration to monitor for adverse effects.  Pt was standing next to his father in the aisle when his father reports he collapsed without warning.  Father carried the pt to the clinic exam room and he was noted to be unresponsive with irregular breathing; he maintained a pulse.  A contusion was noted to his right forehead, right lip, and right chin.  EMS was activated by a bystander and AED was brought into the exam room by the LVN.  Within 10-seconds of lying supine, pt was arousable to tactile stimuli and able to make eye contact.  BP 140/80, HR 64, Sp02 98% on RA, RR 20.  Pt's breathing pattern normalized and he became more alert over the next 2-3 minutes.  EMS arrived and was given a detailed report by the clinic FNP.  Pt reported he had a headache and felt dizzy; he did not recall these symptoms prior to collapsing.  EMS recommended evaluation at the ER but the family declined. When pt was assisted to a seated position for reassessment, pt became acutely dizzy, nauseated and vomited twice into a wastebasket.  BP 116/62, HR 68.  Pt was provided cool, damp towels and he reported symptom improvement after vomiting.  Pt was monitored for an additional 30-minutes before he independently ambulated from the clinic room to his care with his mother and father.
Information has been received from a female consumer (age not reported) who on 06-OCT-2007 was vaccinated with pneumococcal 23v polysaccharide vaccine (lot # 655766/0038U). On 07-OCT-2007, at about 1 AM, the patient awakened with severe pain in the arm where the vaccine had been injected. The entire upper arm was extremely swollen and painful. There was a bright red, itchy rash around the entire upper arm. After repeated ice packs and BENADRYL were applied, the reaction finally ceased. This took about 4-5 days. To date, there were still rash marks visible on her arm. Additional information has been requested.
Fever, body aches, nausea, headache - like having Covid illness again  Left shoulder stiffened and froze. Unable to move freely. As of the date of this report, patient still cannot move the arm freely and is in quite a bit of pain. (Frozen Shoulder)
unable to complete the vaccination series; tennis elbow; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (unable to complete the vaccination series) and EPICONDYLITIS (tennis elbow) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included Mitral valve prolapse (asymptomatic). Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81) and VITAMINS NOS for an unknown indication.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (unable to complete the vaccination series) and EPICONDYLITIS (tennis elbow). At the time of the report, PRODUCT DOSE OMISSION ISSUE (unable to complete the vaccination series) had resolved and EPICONDYLITIS (tennis elbow) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient was prescribed unspecified steroids for tennis elbow.
Less than one week after recieving her influenza vaccine for the 2013/2014 flu season, she developed an intensely pruritic rash of hives that lasted approximately 3 months.  No shortness of breath or anaphylaxis symptoms.  Treated successfully with Benadryl.
Heart enzyme elevated; Small blood clot; Chest pain; Soreness; Low grade fever; Fatigue; This spontaneous case was reported by a patient and describes the occurrence of MYOCARDIAL NECROSIS MARKER INCREASED (Heart enzyme elevated) and THROMBOSIS (Small blood clot) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017C21A and 020B214) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical history was provided.  Concomitant products included LOSARTAN and SIMVASTATIN for an unknown indication.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, 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 experienced MYOCARDIAL NECROSIS MARKER INCREASED (Heart enzyme elevated) (seriousness criterion medically significant), THROMBOSIS (Small blood clot) (seriousness criterion medically significant), CHEST PAIN (Chest pain), MYALGIA (Soreness), PYREXIA (Low grade fever) and FATIGUE (Fatigue). The patient was treated with APIXABAN (ELIQUIS) for Thrombosis, at an unspecified dose and frequency. At the time of the report, MYOCARDIAL NECROSIS MARKER INCREASED (Heart enzyme elevated), THROMBOSIS (Small blood clot), CHEST PAIN (Chest pain), MYALGIA (Soreness), PYREXIA (Low grade fever) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: abnormal (abnormal) found a clot in his right lung.. On an unknown date, Myocardial necrosis marker increased: increased (High) increased.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Labs include ultrasound, chest x-ray ,strep tests whose results are not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-237494 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
A week after the first dose or second dose, patient reports of some chest pains; Had a little bit of trouble breathing; After the first dose, had a slight allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (A week after the first dose or second dose, patient reports of some chest pains) and DYSPNOEA (Had a little bit of trouble breathing) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroid disorder NOS. Concomitant products included TERAZOSIN HYDROCHLORIDE (TERAZIN) for Thyroid disorder NOS.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced DYSPNOEA (Had a little bit of trouble breathing) (seriousness criterion medically significant) and HYPERSENSITIVITY (After the first dose, had a slight allergic reaction). In 2021, the patient experienced CHEST PAIN (A week after the first dose or second dose, patient reports of some chest pains) (seriousness criterion hospitalization). The patient was hospitalized for 1 day due to CHEST PAIN. At the time of the report, CHEST PAIN (A week after the first dose or second dose, patient reports of some chest pains), DYSPNOEA (Had a little bit of trouble breathing) and HYPERSENSITIVITY (After the first dose, had a slight allergic reaction) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Cardiac stress test: negative (Negative) Negative. On an unknown date, Electrocardiogram: negative (Negative) Negative.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment medications were not provided. Patient experienced slight allergic reaction post first vaccination with Moderna but was not sure whether it was anxiety.  Patient never had allergies to a vaccine before. Patient was admitted overnight in the hospital.   This case was linked to MOD-2021-409940 (Patient Link).; Sender's Comments: This case concerns a 52-year-old, female patient with relevant medical history, thyroid disorder who experienced the unexpected events of Allergic reaction, Dyspnea, and Chest pain. The events of allergic reaction and dyspnea occurred approximately 1 day after the first dose of mRNA-1273 (Moderna covid-19 vaccine); patient was admitted into the hospital approximately a week after the first dose for chest pain. EKG and stress test were done, which were both negative. The rechallenge was not applicable, as the event happened after the first dose. This patient's underlying medical condition remains a contributory factor. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.
Within 5 mins of receiving MMR vaccine, to right thigh, SQ,  pt developed a dime sized whelp at the site of injection.  Pt was treated w/ benadryl and tylenol, by weight.
Mom states at 5:00 pm approximately fever began to elevate (101.8 degrees F) reaching & c/o HA & gave 200mg Ibuprofen then went to ER & mom states temp there was 103.6 degrees F.
Child developed rash 1 day after influenza vaccine. Rash spread seen at ER. 10/12/14 diagnosed erythema multiforme : possible secondary to influenza vaccine.
p/vax pt took ASA; pt ate black cherry ice cream cone;had dinner salad w/strawberries, wlanuts, blue cheese, poppy seed dressing, merlot;pt devel itching, swelling hands, lips; vomiting; diarrhea
This spontaneous report as received from medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 06-JUL-2015, the patient was vaccinated with the third dose of improperly stored oral, ROTATEQ oral liquid (lot # L000571, expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Lost the sense of smell; Tested positive for COVID-19; COVID-19; Diarrhea; Sstomach ache; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), HYPOSMIA (Lost the sense of smell), ABDOMINAL PAIN UPPER (Sstomach ache), SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19) and DIARRHOEA (Diarrhea) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (Sstomach ache) and DIARRHOEA (Diarrhea). On 20-Mar-2021, the patient experienced COVID-19 (COVID-19) and SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19). On 21-Mar-2021, the patient experienced HYPOSMIA (Lost the sense of smell). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, COVID-19 (COVID-19), HYPOSMIA (Lost the sense of smell), ABDOMINAL PAIN UPPER (Sstomach ache), SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19) and DIARRHOEA (Diarrhea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Mar-2021, SARS-CoV-2 test: positive (Positive) Tested positive for COVID-19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The reporter was calling on behalf of their husband. The patient received their first dose of the Moderna COVID-19 vaccine on 10-Mar-2021 and then was diagnosed with COVID-19. On 19-Mar-2021, the patient began to have diarrhea and stomachache, and on 20-Mar-2021, the patient tested positive for COVID-19. On 21-Mar-2021, the patient lost the sense of smell.  Concomitant medication included Blood pressure medication. Treatment medication included Tylenol and cough syrup.   This case was linked to MOD21-065375, MOD21-065447 (Patient Link).
At the time of my vaccine, the nurse asked me if I experienced any pain at the site and happened to mention that the needle being used did not retract from my arm.  I did not experience any pain in that moment. Later in the evening, I begun to experience muscle pain at the site of the vaccination but believed it was due to the shot.  It has now been about a week and a half and pain is now in my shoulder and has traveled down my arm.
Shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, several days after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Shingles). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 18-MAR-2023 This case was reported by a patient wife via interactive digital media. The reporter reported that her husband was fully vaccinated with Shingles vaccine  The reporter stated that the patient experienced Shingles shortly after received second dose of Shingles vaccine. The reporter stated that it was damned if you receive the shingles vaccine damned if you did not receive the shingles vaccine. Follow-up would not possible as no contact details were available.
1-31-21 - ~10:00PM - "serum pain" - "severe vasculitis" Head and ear (both) pain  2-1-21 - head and ear (both) pain continued  2-2-21 - head pain 2-3-21 and 2-4-21 - some relief not as bad 2-4-21 - 8:30PM - vasculitis head pain again very bad and sore throat 2-6-21 - head and throat pain - a little tachycardia  2-7-21 - AM - left arm painful again, head and ears bad pain, severe chills, body aches and fever (99.6-100.2) 2-8-21 - head and ear pain, fever 100.0 blisters developed and red spots (uticaria) 2-9-21 - headache pain bad - blisters developed and red spots (uticaria) fever 100.2 - ears red, arms, legs, back, neck - "full blown relapse of vasculitis, more than a flare up." 2-10-21 - head ache, ear ache, body aches, chills fever - 99.8 2-11-21 - fever gone - head and ears still hurt 2-12-21 - head ache still  2-13-21 - feeling a little better 2-14-21 - feeling a little better 2-15-21 - head not good 2-16-21 - head not good Additional notes from the patient:  10-2020 - husband tested positive on 10-16-2020 (sx/sy started on 10-7-2020) Patient that I am reporting for now, says she developed a vasculitis headache on 10-8-20 with head pain, ear pain, on 10-9-2020,10-10-2020,10-11-2020,10-12-2020,10-13-2020, throat, cough, severe chills - on 10-21-2020 she reported NEGATIVE for Covid-19 10-22-2020 - low fever 10-23-2020 - fever; (10-24-2020, 10-25-2020, 10-26-2020, 10-27-2020, all "usual" symptoms increased in severity as well) 10-29-2020 - tested again for COVID-19 came back NEGATIVE - both COVID-19 tests were PCR
Arm swelling and soreness, Headache, Nausea, Muscle Aches, Fatigue
I woke up on 5/7/22 with cold like symptoms. I had a runny nose, cough, draining in my throat, and fatigue. This lasted for about 3 days. I took an at home Covid test that day and tested positive.
First, note that I had no side effects at all at my first Moderna vaccine on March 15.  I barely noticed when the needle was inserted and had virtually no site pain after, and no other symptoms.  Yesterday, the shot itself hurt a lot.  The site pain on my arm is horrific and became bad immediately after the shot.  I slept much of the afternoon after I got the shot, because it was hard for me to get out that early in the day, but when I woke up in the evening, I was extremely sick.  I was extremely nauseated, on the verge of throwing up for a very long time, and could not even brush my teeth.  I also had a really bad headache. Muscle and joint pain all over.  I think I may have had a fever but I couldn't put the thermometer in my mouth. This morning, the day after the vaccine, the nausea is mostly gone, but not totally gone. My body pains are horrible, and my arm pain at the site is the worst. My forehead feels warm but I'm not about to risk taking my temp because I don't want to throw up.  fyi, I also got very sick when I got the Shingrix vaccine a couple of years ago.  I was worse with the first shot, totally out of commission for almost a full week, but still pretty sick with the second shot. But, I slept thru most of it and the discomfort and pain were nothing compared to yesterday.  I'm hoping to progress today and that the worst is over. I'm hoping.  I tend to react badly to lots of meds and procedures, but this is the worst. When I woke up during the nite I wanted to be dead because the pain and nausea were so horrible. At the moment, it feels like my head is going to explode, but that may be because due to the nausea, I couldn't sleep with my retainer last nite or yesterday and I grind my teeth.  I would not make this report if the symptoms weren't so extreme, but truly, last nite was one of the worst in my life of chronic medical problems.
Swelling, pain, itching and redness to injection site.  By the next morning patient had swollen ears and left eye and hives.  Went to Urgent Care- tx: Benadryl and prednisone.  By Sunday morning swelling increased to whole face, hives increased to whole body.  Went to ER, tx: injection of Benadryl and Prednisone.
73 yo male presents with a two day hx for hives and swelling of the  eyelids and penis.  This occurs in the context of a recent influenza and  Pneumovax vaccination on 9/29/09.  He first noted itchy legs and groin yesterday with edema of the upper eyelid yesterday afternoon.  The eyelid edema was worse this morning but has since decreased.  He denies eye irritation or eye itchiness.  There has been no ocular discharge or sticking together of the eyelids.  This morning his wife noted multiple hives on his back and on his legs.  Most of them have resolved or subsided without specific therapy.  He denies dyspnea or wheezing.  He has no prior hx for allergies or reactions to vaccinations.  Further, there is no prior hx for seasonal allergy.  He is otherwise on no new meds or topical products and there has been no recent change  in detergents or soap products.
This spontaneous report as received from a other health professional refers to a patient of unknown age with prophylaxis. On an unknown date the patient was vaccinated with VARIVAX lot # N009766 for prophylaxis. Concomitant therapies included sterile diluent (STERILE DILUENT). On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. This is one of two reports from the same.; Sender's Comments: US-009507513-1708USA002980:
Woke up with lump on left hand on wrist, front & surrounding whole wrist. Lump was hard felt like wart. Next morning spread up arm. Right hand was not as severe but looked like scars under the skin like they were old; not on forearm only on back of hand. Also on back of left hand but smaller - acne like - a couple on back of ankles & back right of legs. Called doctor within 1 week (around October 7) given ointment for allergy; doctor thought that pt was better. 2 weeks later (around October 28) seen by dermatologist but could not give diagnosis. Used ointment for a month but did not work. On January went back to dermatologist, got biopsy done, received something to help her sleep. On February returned diagnosed with purigal nagularis after biopsy. Told that no cure just use continue to use ointment. Pt thinks vaccine triggered skin problems. Currently seeing general physician and running blood tests. For itch pt taking hydroxyzine capsules and clobetasol cream. Has taken 6 different medications none of them worked.
"A territory representative reported that an infant received Prevnar, Acel-Imune, Hib-Titer and IPOL vaccines on 8/29/00. Approx. 24 to 36 hours, post vax, the parents observed that the infant no longer responded to noise. No further information was available at the date of this report."
Itching - hives - went on 9/25/13 AM to urgent care: administered steroid shot and prescribed prednisone 10 mg 3/day for 5 days and cetirizine 10mg at bedtime. 9/26 body covered w/ hives - went to primary Dr who prescribed hydroxyzine 25 mg every 6 hours.
Large red ?rash? on same arm as vaccine but NOT directly at injection site. Warm to the touch and very sore like a bruise. Continued to get larger covering most of upper arm over a few days. About 5 days later started to dissipate and was itchy as it was going away.
soreness in the right arm; flu-like symptoms; low-grade temperature; chills; body aches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness in the right arm), INFLUENZA LIKE ILLNESS (flu-like symptoms), PYREXIA (low-grade temperature), CHILLS (chills) and MYALGIA (body aches) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Alpha-gal allergy.  On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 03-Mar-2021, the patient experienced VACCINATION SITE PAIN (soreness in the right arm), INFLUENZA LIKE ILLNESS (flu-like symptoms), PYREXIA (low-grade temperature), CHILLS (chills) and MYALGIA (body aches). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 04-Mar-2021, INFLUENZA LIKE ILLNESS (flu-like symptoms), PYREXIA (low-grade temperature), CHILLS (chills) and MYALGIA (body aches) had resolved. On 06-Mar-2021, VACCINATION SITE PAIN (soreness in the right arm) had resolved.     Concomitant product use was not provided by the reporter.   This case was linked to MOD-2021-009093, MOD-2021-076802 (Patient Link).