chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sudden onset inconsolable screaming lasted 4 hrs; would not breast feed; no fever; stiffened extremities;
Pt experienced burning at injection site. One hour later, experienced redness extending around arm, warm to touch, very sore. Took band aid off in the evening and skin came off with it. Seen by MD that evening, diagnosis cellulitis. Pt was given Augmentin, and went to MD again in a couple of days and then was diagnosed with a triple ulcer. Pt saw MD daily for 1 week for dressing changes. Didn't heal, pt sent to wound clinic at hospital for dressing changes. Thick scabbing as of today it has healed but remains painful and is scarred. Allergy tested for ingredients in flu vaccine - all negative. Pt has had the flu vaccine in the past with no problems.
pt recvd MMR vax MAY87 & approx 1-2 months following vax, pt c/o lt hip pain; c/o stiffness of the fingers; x-ray demonstrated mild degenerative joint disease; CT scan of the pelvis & spine were neg;
(Copied from ED Attending Progress Note). FLU SHOT YESTERDAY. Onset itching/wheal 0630, angioedema of lips onset 0800, no SOB/dysphagia.  Took his meds ate breakfast this am. Wheal and itching propagating across skin.  (Copied from ED Nursing Progress note) 1130 DIPHENHYDRAMINE 50mg IV push given.  1130  RANITIDINE TAB  300MG po given  1130   EPINEPHRINE  250MCG IM gived on left deltoid. 1130  DEXAMETHASONE 12mg IV push given.
pt vaxed 830-9 4SEP92 nausea, dizziness, arm hurt from elbow up ear hurt also numbness; swollen under ear & in shoulder;
The report was first received from practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 16-NOV-2017, the patient was vaccinated with ROTATEQ (strength were unknown, lot# M042169 and expiration date 22-JUN-2018) 1 dose form orally for prophylaxis (product storage error). No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017 was 47 degree Celsius for max 15 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001958.
Patient stated that a week after getting the first dose of the covid vaccine she developed red bumps on her face.
coughing; aching; fever; Initial information received on 12-Dec-2020 regarding an unsolicited valid non-serious social media case received from a non-healthcare professional (patient).  This case involved an adult patient of an unknown age and gender who experienced coughing (cough), aching (pain) and fever (pyrexia), after receiving INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, expiry date and other dosing details were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, unknown latency, the patient reported that every single time when the patient have had a flu shot, it was followed by four weeks of coughing, aching, and fever. Sure, it could've been coincidence or it could be that the patient react flu shots very negatively.   No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  Outcome of the events was reported as unknown.  There will be no information available on the batch number for this case.
Patient had a fever for 8 hours post-vaccine on 04/10/2021. On 04/11/2021, patient states fever resolved but then developed swelling around lips, "goose-egg lump on forehead",  around 9AM. Swelling has moved from lips to jawline and still present on 04/13/2021. Patient reports having a "chicken pox like rash" on arms, "welt-like spot" on left inner wrist and ankle, and also had itchiness. Patient took cold-medicine hoping that would help with swelling. Patient states rash and welts have disappeared as of 04/13/2021. Patient advised to contact healthcare provider and consider taking Benadryl/antihistamine.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): MDEM22-02553 (Moderna). A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 03Jul2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: coviD-19 vaccine AstraZeneca (Dose 1), administration date: 17Apr2021, for Covid-19 immunization. The following information was reported: RESPIRATORY FAILURE (medically significant), outcome "unknown"; CIRCULATORY COLLAPSE (medically significant), outcome "unknown", described as "circulatory disorders"; ARRHYTHMIA (medically significant), outcome "unknown", described as "cardiac arrhythmia"; DYSPNOEA (non-serious), outcome "unknown", described as "shortness of breath"; NERVOUS SYSTEM DISORDER (non-serious), outcome "unknown", described as "nervous system dysfunction"; DIZZINESS (non-serious), outcome "unknown"; TINNITUS (non-serious), outcome "unknown". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
On 3/8/2021 the patient presented to the ED with stroke-like symptoms. Reason for admission: suspected TIA.  Acute CVA-has been ruled out. Incidental finding CT head 9 x 5 mm lesion possibly meningioma, but scans of CTA head and neck no lesion, MRI of the brain shows no lesions.
Headache, chills, body and joint aches on 20210327 04:00 AM till about 11:00 PM; took 2 regular Tylenol at 04:30 AM.  On 20210327 about 11:00 AM, temperature of 100.2,; took 2 regular Tylenol at 11:30 AM.  At about 5:30 PM on 20210327 temperature of 101.3 and at 10:30 PM temperature of 100.2.  On 20210328 at 09:00 AM, no fever and aches gone.  Area on arm where vaccinated, red and warm to the touch.  Hives had developed on both upper arms.  Around 10:00 PM on 20210328 discovered more hives on both calves and around neckline.  On 20210329 07:30 AM some more hives across lower back, other hives still present.
She was given 3 times (overdosed)/ Overdose on 2nd shot / 2nd shot was 2x dosage; Doses administered accidentally/ unintentionally  1 month apart; Left arm of injection has a big bump; Left arm of injection itchy; Left arm of injection painful; Left arm of injection red; Nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (She was given 3 times (overdosed)/ Overdose on 2nd shot / 2nd shot was 2x dosage), INCORRECT DOSE ADMINISTERED (Doses administered accidentally/ unintentionally  1 month apart), VACCINATION SITE MASS (Left arm of injection has a big bump), VACCINATION SITE PRURITUS (Left arm of injection itchy) and VACCINATION SITE PAIN (Left arm of injection painful) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 013L204) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroiditis, unspecified. Concomitant products included LEVOTHYROXINE for Thyroiditis, ESTRADIOL, PROGESTERONE and CALCIUM for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced ACCIDENTAL OVERDOSE (She was given 3 times (overdosed)/ Overdose on 2nd shot / 2nd shot was 2x dosage), INCORRECT DOSE ADMINISTERED (Doses administered accidentally/ unintentionally  1 month apart), VACCINATION SITE MASS (Left arm of injection has a big bump), VACCINATION SITE PRURITUS (Left arm of injection itchy), VACCINATION SITE PAIN (Left arm of injection painful), VACCINATION SITE ERYTHEMA (Left arm of injection red), NAUSEA (Nausea) and HEADACHE (Headache). The patient was treated with ACETAMINOPHEN at a dose of 1 dosage form. On 24-Feb-2021, ACCIDENTAL OVERDOSE (She was given 3 times (overdosed)/ Overdose on 2nd shot / 2nd shot was 2x dosage) and INCORRECT DOSE ADMINISTERED (Doses administered accidentally/ unintentionally  1 month apart) had resolved. At the time of the report, VACCINATION SITE MASS (Left arm of injection has a big bump), VACCINATION SITE PRURITUS (Left arm of injection itchy), VACCINATION SITE PAIN (Left arm of injection painful), VACCINATION SITE ERYTHEMA (Left arm of injection red), NAUSEA (Nausea) and HEADACHE (Headache) had resolved.            Treatment medication included Acetaminophen, Patient took it day before reporting night, and 2 more doses on the day of reporting. Concomitant medication also included unspecified thyroid medicines and eye medicines.  It was reported that the 1st shot was fine. 2nd shot was 2 dosage. In few days symptoms were gone and there was no recurrence of symptoms.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Clinical course information and event outcome updated to resolved.
This spontaneous report as received from a pharmacist refers to a patient of unspecified demographics. Patients concurrent condition included asthma. On 11-APR-2014, the patient was vaccinated with ZOSTAVAX, dose 0.65 ml, subcutaneous. Concomitant therapy was unspecified. Approximately in April 2014, the patient experienced exacerbation of asthma. The patient sought medical attention (unspecified). The physician has prescribed him Prednisone 40 milligram (mg) for five days. It was reported that the patient has not begun prednisone treatment. No product quality complaint was involved. The outcome of exacerbation of asthma was reported as recovering. The reporters causality assessment for the event exacerbation of asthma with the therapy of ZOSTAVAX was not reported. No further information was provided. Additional information is not expected.
Patient spoke to his brother within days of the vaccination and reported that he was unable to walk due to severe leg pain that started a day or so after the first Pfizer vaccination. The victim's brother couldn't remember which arm or leg but the victim reported that it was the leg on the same side as the vaccination. The victim was vaccinated due to heavy mandates and not being able to go out to restaurants without proof of vaccination. The victim was found dead on his couch on 10/23/21 with a plate of take out in his lap. He was thought to have been dead 3 days by the time he was found. Coroner's report showed victim died of a coronary or heart condition, possible heart attack. Victim had no known history of heart disease.
local redness, swelling & pain @ inj site;began 6-8hr p/vax;18SEP 48hr p/inj erythema is 4" x 4" diameter rt deltoid;arthus type rxn;
Swelling to (L) shoulder -> elbow with warmth/pain to touch. Tenderness to (L) axilla over lymph nodes. Nausea/fever/ no problems at injection site.
Severe lower back pain determined to be a kidney infection of unknown cause. And it's still under investigation. Blood in the urine.
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 23-NOV-2015 at time- 03:17, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L016427 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 3.3 and 1.9 (units unspecified) for 10 minutes respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
vaccine administered approximately 0715 am 12 Nov ...that same day by late afternoon and evening member felt onset body aches, torso itching that evening......13 Nov 13, member tried tylenol ES with minimal relief of body aches .....myalgia increased along with fever and paresthesias and numbness of both feet by that evening....went to ER and was admitted
Initial report was received on 15 November 2011 from another manufacturer national service center (service request number 1-4616113286), who received the report from a health care professional. A male patient (age not reported) with an unreported past medical history had received a tetanus vaccine (manufacturer, lot number, route and site of administration were not reported) and a Penicillin injection (manufacturer not reported) on an unspecified date 30 years ago. His throat later swelled up (time to onset unspecified). Treatments were provided (unspecified). No further information was provided and at the time of the report. The patient's outcome was reported as recovered (date unspecified). Documents held by sender: none.
Patient reported the day after IMZ that his arm had a red rash. No pain or edema, area was not hot to the touch. Patient returned today, 3 days later, and rash was still present, covered 2X3 inch area with non-defined borders. Patient took an OTC NSAID and antihistamine, and will try a cool compress. Patient reports it is improving and going away.
Uncontrollable chills, fever, headache, soreness on shoulder and near arm pit.
The patient was vaccinated with the second dose of COVID-19 Pfizer before 21 days.  The patient arrives at the facilities of Vaccination Center, patient tells the staff that she has an appointment for her second dose, they register it as walk-ins and the vaccine is administered, later the staff realized that the first dose was administered 15 days before
Patient c/o dizziness, nausea, diaphoresis, tinitus. Patient states this occurs after every vaccination due to her fear of vaccinations/needles. Patient moved to a cot via wheelchair and placed in trendelenberg for approximately 30 minutes. Offered water, crackers. Symptoms resolved and she exited clinic without difficulty, accompanied by a friend.
Fever..effected all areas of arthritic inflammation. That night I could hardly walk to th bathroom
Pt. came in today and described the adverse event. He received the vaccine on Wednesday, 4-4-18. On Monday, 4-9, he was speaking on the phone with his son that evening when he started feeling ill. After he hung up, he tried to walk to the door and fell in the floor, could not get up due to extreme dizziness, nausea, etc. An ambulance was called and transported him to the hospital where he remained for 2 days. His family physician did not think the vaccine was responsible, but apparently a specialist, after being told of the vaccine administration, said he was sure that that was the cause of the problem, diagnosing it as Vestibular Neuritis. Patient complained of dizziness, vision disturbances and trouble walking. He is still receiving physical therapy and says his vision has not returned to normal.
CEREBRAL VEIN SINUS THROMBOSIS OF THE LEFT TRANSVERSE SINUS; This spontaneous report received from a patient via a company representative concerned a patient of an unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total administered on 24-AUG-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On 24-AUG-2021, immediately after receiving vaccine the patient felt adverse effects, continued to have complications and received a battery of neurological tests, including MRIs (Magnetic resonance imaging), MRVs (Magnetic resonance Venography), and MRAs (Magnetic resonance Angiography). The patient had visited physician office. Doctor found that the patient experienced Cerebral Vein Sinus Thrombosis of the left transverse sinus. The patient have endured pain and suffering and negative career implications. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of cerebral vein sinus thrombosis of the left transverse sinus was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20230151219- Cerebral vein sinus thrombosis of the left transverse sinus- The event has a compatible/suggestive temporal relationship, and is labeled. There is no information on any other factors potentially associated with the event. Therefore, this event is considered consistent with vaccine administration.
tested positive to Covid virus after 1st shot of the Moderna Covid-19 Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive to Covid virus after 1st shot of the Moderna Covid-19 Vaccine) in a female patient of an unknown age 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 an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive to Covid virus after 1st shot of the Moderna Covid-19 Vaccine). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive to Covid virus after 1st shot of the Moderna Covid-19 Vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment information was provided by the reporter
Was around 15-16 weeks pregnant at time of vaccination. After vaccine had worsening of existing hyperemesis symptoms x 48 hours, which including not being able to eat and only being able to tolerate clear liquids. Symptoms returned to baseline after 48 hours
Pain in (L) arm day of injection, then pain in biceps, the following day, the bulla on (R) biceps area. Tender along upper arm, no erythema/heat/fevers.
This spontaneous report as received from a 77 years old female consumer reporting on herself with atrial fibrillation, restless legs, penicillin allergy and allergic reaction to clindamycin and BIAXIN. The patient was vaccinated with ZOSTAVAX (dose, route, site of administration and lot # not reported) on 11-NOV-2006. No other co-suspects were reported. Concomitant medications included clonazepam, atorvastatin, diltiazem, warfarin, omeprazole, ZETIA, sertraline hydrochloride and ALIGN probiotic. The consumer reported that she was diagnosed with shingles on 06-JUL-2012. She developed left sided chest pain on 05-JUL-2012, she was evaluated at an unspecified urgent care facility and was told that the pain was "structural". The next day on 06-JUL-2012, the consumer returned to the unspecified urgent care facility due to increased chest pain. From that facility, the patient was taken by ambulance to the emergency room. The patient was admitted and diagnosed with shingles. Treatment included morphine, VALTREX and OXYCONTIN. Unspecified blood tests, cardiac stress test and echocardiogram were performed (results not provided). The outcome of shingles was reported as not recovered. The relatedness for shingles in unknown for ZOSTAVAX. Additional information has been requested.
Mother reports that son developed symptoms of fatigue, tingling sensation in left ankle/leg with single episode nonbilious/nonbloody vomitus with achiness in neck and shoulder region around day #2-3 after vaccine given with full recovery in 1-2 days. Mother reports child with ill contacts with symptoms of vomiting/diarrhea.
eyes irritated; left arm a red lump that's been red and warm to touch/the spot where they gave vaccine is swollen with large, hot, red, hard lump; left arm a red lump that's been red and warm to touch/the spot where they gave vaccine is swollen with large, hot, red, hard lump; left arm a red lump that's been red and warm to touch/the spot where they gave vaccine is swollen with large, hot, red, hard lump; numbness in both arms left and right(from elbow down)/arms from the elbow down were completely numb, states if felt like they were asleep, like the tingly numbness; tiredness/tired; both of her arms from the elbow down were completely numb, states if felt like they were asleep, like the tingly numbness; itching/eyes were irritated, itchy and swollen; swollen/ her eyes were irritated, itchy and swollen; left arm a red lump that's been red and warm to touch/the spot where they gave vaccine is swollen with large, hot, red, hard lump; This is a spontaneous report from a contactable consumer. This 23-year-old female consumer (patient) reported that she received bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration, administered in Arm Left on 29Jan2021 (Batch/Lot Number: EL9265) as SINGLE DOSE for covid-19 immunisation. Medical history included polycystic ovaries from an unknown date and unknown if ongoing. Concomitant medication included metformin (METFORMIN) taken for polycystic ovaries from 2018 and ongoing. Patient reported side effects after the first dose of the Pfizer vaccine. She experienced "numbness in both arms left and right (from elbow down), tiredness, eyes irritated, itching and swollen, left arm a red lump that's been red and warm to touch since Saturday. The second dose, should I get?" Caller wants to report the side effects from vaccine, clarifies the Covid vaccine. States she received the vaccine on Friday, 29Jan2021 at 9:05AM. Caller states both of her arms from the elbow down were completely numb, states if felt like they were asleep, like the tingly numbness, that she was tired, her eyes were irritated, itchy and swollen, and the spot where they gave vaccine is swollen with large, hot, red, hard lump. States she got the vaccine in her left arm. Caller would like some information about these side effects. NDC and Expiration date are unknown. Caller declined to provide HCP information. The action taken in response to the events for bnt162b2 was not applicable. The outcome of the events injection site redness, Feeling hot, Limb mass was not recovered for events itching/eyes were irritated, itchy and swollen, swollen/ her eyes were irritated, itchy and swollen, Injection site swelling, Paraesthesia was unknown for event tiredness was recovering and for events numbness in both arms left and right(from elbow down)/arms from the elbow down were completely numb, states if felt like they were asleep, like the tingly numbness, eyes irritated was recovered.
Sore arm on 3/20/2021.  No other symptoms/signs.  Presented for routine heart transplant follow up visit 3/22/2021 and was found to have new decreased cardiac function by echo, new 1st degree heart block by ECG, and new gallop.  Patient taken to cath lab 3/22/2021 for biopsy and hemodynamic assessment, but he had V fib arrest with anesthesia induction.  After initiation of CPR, patient was placed on ECMO.  Biopsy shows ACR 2R (moderate cellular rejection) and pAMR 2 (moderate antibody-mediated rejection).  Labs show new donor specific, complement-fixing Antibody against the cardiac allograft.  Patient is in ICU being treated for acute rejection.
Patient reported painful, red swollen area to Left deltoid at site of vaccine on 11/1/17, ice and ibuprofen x 24 hours without good effect. Seen in office and prescribed cephalexin TID x 7 days for cellulitis.
pt temp 103-rash all over, congested, fussy, eyes slightly swollen, sleepy, does not want to eat, swollen glands in throat
Rash, itching, redness of skin all over body, hives, sore throat leading to chest pain