chrisvoncsefalvay/vaers-outcomes huggingface dataset:
5/4-5/6: PRURITIC RASH DEVELOPED AT INJECTION SITE 5/7 - HIVES STARTED, TREATED WITH PREDISONE 50 mg qd x 5 days  5/8-5/10: HIVES, SWELLING ON UPPER & LOWER LIPS, SWELLING OF EYES 5/10 - HIVES, SWELLING OF EYES/MOUTH, SHORTNESS OF BREATH, TIGHTNESS AROUND CHEST; HIGH BLOOD PRESSUE,SWELLING IN POSTERIOR OROPHARYNX, SWELLING ON UPPER & LOWER LIPS, URTICARIA & MULTIPLE PAPULES ON BOTH ARMS, TORSO & BOTH LEGS -> WENT TO URGENT CARE WHERE WAS GIVEN AN EPIPEN THEN 911 CALLED &TAKEN TO THE HOSPITAL FOR FURTHER OBSERVATION OF ANAPHYLAXIS 5/11-5/15 - BRUISING; TAKING PREDISONE, BENADRYL, PEPCID AND CLARATIN. SYMPTOMS SUBSIDED DURING COURSE OF TREATMENT 5/26 - HIVES, SWELLING OF EYES/MOUTH, SHORTNESS OF BREATH, TIGHTNESS AROUND CHEST -> EPIPEN INJECTION ADMINISTERED 6/6 - HIVES AROUND ANKLE AREA AND SWOLLEN FEET/ANKLES  6/12 - WORST REACTION YET, HIVES, EYES SWOLLEN SHUT, SHORTNESS OF BREATH AND LIPS SWOLLEN -> EPIPEN INJECTION ADMINISTERED; LINGERING SIDE EFFECTS (SWOLLEN EYES, RASH HAVE NOT SUBSIDED COMPLETELY AS OF TODAY) - CONTINUING BANOPHREN AND CLARITIN TREATMENT DAILY
Severe Dizziness fatigue 330am 01/07/2022. Required  Emergency room University Hospital 01/09/2022
giant hives, all over body;appeared 10/9/99;ER visit 10/9 or 10/10-steroids & DPH rx hives came & went then progressed to entire body;
Patient reports woke up 9/24/10 with generalized hives, periorbital edema, itchy throat. Took BENADRYL 50mg BID for 12 days. Symptoms did not resolve. Went to private physician 10/4/10 and prescribed tapering course of prednisone, BENADRYL and have Epi pen for future emergencies. Reports decrease in symptoms today. Returns to physician in 1 week.
08/11/2005 9:00 am vaccine injections for Typhoid fever, Hepatitis A and Tetanus. Noon lunch salad at open salad bar. Blood sugar 160 evening fever about 102. 08/12/2005 Aches in joints all day and headache no appetite. Some relief from Advil (every 4 hours). Evening fever returns. Headache. BS 150 before breakfast. 08/13/2005 Sharp flashing pain to knee, elbow ans shoulder joints with constant background ache. No appetite. Felt warm all day elevated temp about 100. Evening temp returns to 101-102. BS 108 before breakfast. 08/14/2005 Same as previous day except that a shallow cough developed, like a irritation in the throat that caused a cough but cough is shallow. Used Advil to relieve headaches. 08/15/2005 Still have  joint pain and now ringing in ears. Daytime fever is reduced but returns toward th end of the day. Chills and sweat at night. Cough continues. 08/16/2005 Headache, joint pain flashes of pain through the body. BS 106 Fever 102 but seemed to break during the night. Cold sweat during night, stomach ache at night, cough continues. 08/17/2005 stomach ache, Headache, joint pain, BP 158/85 Pulse 91, BS 195 after dinner, cough continues. 08/18/2005 Morning bowel movement, relieved stomach ache, BP 124/85 Pulse 97. Morning BS 192, Ate a peach and apple at about 2am.
her doctor said most likely she had been exposed to COVID-19 virus before the first shot.; second dose will be greater than day 36 if she does get it; random itchiness all over body; stinging of face and arms; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SUSPECTED COVID-19 (her doctor said most likely she had been exposed to COVID-19 virus before the first shot.), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose will be greater than day 36 if she does get it), PRURITUS (random itchiness all over body) and PAIN (stinging of face and arms) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced PRURITUS (random itchiness all over body) and PAIN (stinging of face and arms). On an unknown date, the patient experienced SUSPECTED COVID-19 (her doctor said most likely she had been exposed to COVID-19 virus before the first shot.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose will be greater than day 36 if she does get it). At the time of the report, SUSPECTED COVID-19 (her doctor said most likely she had been exposed to COVID-19 virus before the first shot.), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose will be greater than day 36 if she does get it) and PAIN (stinging of face and arms) outcome was unknown and PRURITUS (random itchiness all over body) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported.  No Treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Reporter contact information updated, Added events 'stinging of face and arms' and 'her doctor said most likely she had been exposed to COVID-19 virus before the first shot' having outcome unknown On 22-Jul-2021: Follow-up received on 22-July-2021 and contains no new information.
Arm pain in which he cannot raise arm well and that OTC pain relievers do not help. Truck driver and cannot use that arm to shift gears. No improvement after 9 days.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient might have received an improperly stored dose of PEDVAXHIB lot # N001348 with an expiration date of 31-OCT-2019 (exact dose and route of administration were not reported). Administered dose of vaccine underwent a temperature excursions between 9 degrees Celsius to 25 degrees Celsius for 1 hour and 13 minutes which was detected by a digital data logger. No previous temperature excursions were reported. No adverse effect reported.
About supper time arm felt sore and started swelling, redness to elbow right arm, three fingers feeling numb. About 10pm started chills, no temperature, hallucinating, thought he was in shed at work although he is retired. Thought he had respiratory problem. Wanted to take him to emergency room about 3am, but he refused. He was better by morning and only felt tired and weak but did not call ? related by wife. 10/29/02
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 17-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) at the age of 17 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: product=COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: It was not known patient received other medication in 2weeks. She received the treatment Paxlovid from 16Oct2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case, an association between the reported events drug ineffective and covid 19 and suspect product bnt162b2 cannot be ruled out.
Given only the liquid component; Given only the liquid component; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a neonate male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 30th December 2021, the patient received Menveo. On 30th December 2021, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication, inappropriate dose of vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate preparation of medication, inappropriate dose of vaccine administered and inappropriate age at vaccine administration were unknown.  Additional details were provided as follows: The reporter reported that a patient was administered only the liquid component of the Menveo vaccine inadvertently, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The recommended age for getting Menveo was at least 2 months of age, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
stomach flu/stomach bug; Rash on the right side of her abdomen that spread; warm to the touch [Localised feeling of warmth]; redness; Initial information received from United States on 04-Nov-2023 regarding an unsolicited valid non-serious case received from a Patient. This case is courtesy received from Regulatory Authority.  This case involves a 56 years old female patient (87.7 kg) who experienced stomach flu/stomach bug, rash on the right side of her abdomen that spread, warm to the touch [localised feeling of warmth] and redness after receiving vaccines moderna covid-19 vaccine and influenza vaccine.  The patient's past medical treatment included Remodulin.  The patient's past medical history, vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Pulmonary arterial hypertension.  Concomitant medications included bifidobacterium lactis (probiotic [bifidobacterium lactis]); curcuma longa (turmeric [curcuma longa]); prednisone (prednisone); levothyroxine sodium (unithroid); fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (trelegy); tadalafil (tadalafil); carvedilol (carvedilol); atorvastatin (atorvastatin); cyanocobalamin (vitamin b12 [cyanocobalamin]); metformin (metformin); rabeprazole (rabeprazole); iron (iron); oxygen (oxygen); valsartan (valsartan); calcium (calcium); magnesium (magnesium); ascorbic acid (vitamin c [ascorbic acid]); salbutamol (albuterol [salbutamol]); furosemide (lasix [furosemide]); montelukast (montelukast); cetirizine hydrochloride, pseudoephedrine hydrochloride (zyrtec-d); guaifenesin (mucinex); rosuvastatin calcium (crestor); ambrisentan (ambrisentan); hydrochlorothiazide, spironolactone (spironolactone and hydrochlorothiazide); ergocalciferol (vitamin d2); vitamin b nos (b complex [vitamin b nos]); empagliflozin (jardiance); and magnesium sulfate (epsom salt).  On 15-Oct-2023, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site (dose, formulation, strength and expiration date: not provided) for Immunisation.  On an unknown date, the patient received a dose of suspect moderna covid-19 vaccine not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site (dose, formulation, strength and expiration date: not provided) for Immunisation.  On an unknown date and month in 2023 the patient developed stomach flu/stomach bug (gastroenteritis viral), rash on the right side of her abdomen that spread (rash), warm to the touch [localised feeling of warmth] (feeling hot), redness (erythema) (unknown latency) following the administration of influenza vaccine and moderna covid-19 vaccine.  Relevant laboratory test results included: Weight - In September 2023:  [182.6 lbs]; in October 2023:  [183 lbs]  Action taken- not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for all the events.
Severe Headache traveling done neck and into lower back.  Pain severe enough unable to rest/sleep, difficulty with vision on concentrating and being able to read
My daughter has had absence seizures since her 7 th grade vaccines. She had a grand Mal seizure on 08/04/2018. Never had any symptoms like this before shots.
Pt was looked up in the registry on May 11th to see if they were due for their 4th dose of vaccine at the request of the the facility he resides in.  Pt was due and scheduled for onsite vaccine clinic on 5/17/22.  Pts daughter picked him on the 18th and took him a doctors appointment.   They gave him a booster dose of Moderna at this visit. Neither the pt or the daughter informed the facility of the vaccine given.  On 5/17/22 pt was asked questions by the facility nurse from the IAC prevacination checklist.  Pt stated he has had 3 doses of thus far of Covid vaccine.  Pt was given a booster dose of Moderna vaccine at this vaccine clinic day.    Daughter called an informed pharmacy of incident on 5/20/22.  Daughter reported no adverse reactions.  Pharmacy called PCP to inform them and they also notified local health office. Nurse at pcp stated as long as the pt doesn't show any adverse reaction there is no reason report anything back to them. Pt was put on 2 hours checks by the Facilty nurse.  The pharmacist followed up with nurse and the patient still showing no adverse reaction on this date.
Left arm sore within 12 hours of each dose; Headache; exhaustion; felt nauseated; shortness of breath; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 17Dec2021 14:00 (Lot number: FF2S89) at the age of 48 years as dose 3 (booster) , single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ENS318, Location of injection: Arm Left, Route of Administration: Intramuscular, Left arm sore within 12 hours of each dose.), administration date: 23Mar2021, for Covid-19 Immunization, reaction(s): "Left arm sore"; Bnt162b2 (Dose Number: 1, Batch/Lot No: ENS318, Location of injection: Arm Left, Route of Administration: Intramuscular, Left arm sore within 12 hours of each, dose.), administration date: 02Mar2021, for Covid-19 Immunization, reaction(s): "Left arm sore". The following information was reported: IMMUNISATION (non-serious) with onset 17Dec2021 14:00, outcome "unknown", described as "Booster"; PAIN IN EXTREMITY (non-serious) with onset 18Dec2021, outcome "recovered" (2021), described as "Left arm sore within 12 hours of each dose"; HEADACHE (non-serious) with onset 18Dec2021, outcome "recovered" (2021), described as "Headache"; FATIGUE (non-serious) with onset 18Dec2021, outcome "recovered" (2021), described as "exhaustion"; NAUSEA (non-serious) with onset 18Dec2021, outcome "recovered" (2021), described as "felt nauseated"; DYSPNOEA (non-serious) with onset 18Dec2021, outcome "recovered" (2021), described as "shortness of breath". Therapeutic measures were not taken as a result of pain in extremity, headache, fatigue, nausea, dyspnoea.  Additional information: No other vaccine in four weeks. Left arm sore within 12 hours of each dose. Experienced Headache and exhaustion, felt nauseated, shortness of breath. The  patient not tested COVID prior vaccination and tested post vaccination. No known allergies.  No follow-up attempts are possible. No further information is expected.
This spontaneous reprot was received from a medical assistant refers to an unknown number patient of unknown demographics. Medical history, concurrent conditions and drug reactions/allergies of these patients were not reported. On unspecified dates, these patients were inadvertently vaccinated with improperly stored oral, ROTATEQ (strength, dose/frequency, lot # unspecified) (incorrect product storage). Concomitant medication was not reported. No adverse effects were reported. This is one of the five reports received from the same reporter. Additional information is not expected, no contact details were provided.
lt arm warm, tender a 2x3cm area @ site; ran fever & nausea;
Localized allergic reaction, raised red, itchy, firm to touch, size of tennis ball. Very sore to touch. Began to subside after 24hrs. Still itchy today.
headache, high pulse rate, light headed, feeling like shes going to pass out, faint, stroke on and off for 3 weeks
Severe N/V for about 2 hours. It was sudden onset, then I vomited about 12 times, then I had persistent nausea for another 12 hours. All was associated with chills and myalgia and subjective fever. Those symptoms were mild to moderate but the vomiting was severe.
Redness (Injection Site); A spontaneous report was received from a consume concerning a 67 year old, female patient who experienced redness on the injection site.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.     On 13-Feb-2021, approximately 8 days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 006M20A) intramuscularly unspecified location for prophylaxis of COVID-19 infection.    On 20-Feb-2021, the patient experienced injection site redness. Treatment information was not provided.    Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event injection site redness was not reported.  The reporter assessed the event injection site redness related to the study drug was unknown.
SVT 170s-Adenosine x1-converted back to ST 130S Palpitation/tachycardia-magnesium and phosphorous IV medication administered; Cardizem oral administered-HR controlled
Blood clot; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clot) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported.). Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    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 THROMBOSIS (Blood clot) (seriousness criterion medically significant) and COVID-19 (COVID-19). At the time of the report, THROMBOSIS (Blood clot) and COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: positive (Positive) postive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Products known to have been used by the patient, within two weeks prior to the event, included blood thinner medication. Treatment information was 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.; 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.
Patient has a debilitating headache on the Friday, Saturday, and Sunday after the second dose. He still had the headache but not as bad on Monday, Tuesday, and Wednesday after the second dose. On Wednesday morning, he passed out three times while in the shower and bathroom. He has been admitted to the hospital. They have ruled out a heart attack and most likely ruled out a stroke. He is still undergoing tests.
lump formed on the back of my arm near the shot and it's hurting; a hard lump formed at the injection site, approximately 3 weeks after getting the vaccine/did not examine the patient's reported induration in person/lump formed on the back of my arm near the shot; This spontaneous report was received from a pharmacist referring to a 53 years old female patient. Information about medical history, concurrent conditions and concomitant therapies was not provided.  On 14-OCT-2019 the patient was vaccinated with one dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (Albumin status of rHA (recombinant human albumin)) (M-M-R II) (lot # S015428, expiration date 20-MAY-2021; strength was not reported) subcutaneously and sterile diluent(STERILE DILUENT) (lot # S024969, expiration date 17-MAR-2021; strength, dose, frequency and route were not reported) for prophylaxis. On approximately 04-NOV-2019 (reported as approximately 3 weeks after getting the vaccine), a hard lump and induration formed at the injection site, lump formed on the back of the patient's arm near the shot and it was hurting. No treatment provided. No other adverse symptoms was reported. The outcome of the events was reported as not recovered. The patient sought medical attention. The patient was referred to a surgeon for examination and possible removal. The causality assessment was not reported by pharmacist and another healthcare provider told the patient induration did not appear to be from the vaccine.
Hospitalized with COVID pneumonia, septic shock, encephalopathy,  hypoxemic respiratory failure
Initial information received on 11-Jan-2019 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a male patient (age unknown) who experienced back pain and bump on the head, while he received vaccines MENACTRA, ADACEL, HPV Vaccine and TRUMENBA. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 09-Jan-2019, the patient received a 0.5ml dose of suspect Meningococcal A-C-Y-W135 (D CONJ) Vaccine lot number, expiry date not reported via intramuscular route in the right arm. On 09-Jan-2019, the patient received a 0.5ml dose of suspect Diphtheria-2/Tetanus/5 AC Pertussis Vaccine lot number, expiry date not reported via intramuscular route in the right arm. On 09-Jan-2019, the patient received a dose of suspect HPV Vaccine and TRUMENBA not produced by Sanofi Pasteur lot number, expiry date not reported via unknown route in the left arm. On an unknown date, the patient experienced a non-serious back pain and bump on the head (swelling) (Unknown latency) following the administration of MENACTRA, ADACEL, HPV Vaccine and TRUMENBA. Lab data not reported. Final diagnosis was bump on the head and back pain. It was an actual medication error due to extra dose administered. Child was administered MENACTRA and TRUMENBA at the same time. It was not reported if the patient received a corrective treatment. The event outcome was not reported for the events. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Myalgias, rigors, fever 100.2, chills, sweating. localized site tenderness only, no rash noted. Rest, increase fluids, ice to upper arms as needed, ibuprofen 400mg every 6-8 hours for pain/fever.
Since my vaccine I have have been diagnosed with both Celiac Disease, Vitamin D Deficiency, and Hashimoto?s Disease. I currently take Levothyroxine and Vitamin D supplements. Symptoms first started about a month after my vaccine.