chrisvoncsefalvay/vaers-outcomes huggingface dataset:
got sick; headache; diarrhea; cold symptoms; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got sick), HEADACHE (headache), DIARRHOEA (diarrhea) and NASOPHARYNGITIS (cold symptoms) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, the patient experienced ILLNESS (got sick), HEADACHE (headache), DIARRHOEA (diarrhea) and NASOPHARYNGITIS (cold symptoms). On 25-May-2021, ILLNESS (got sick), HEADACHE (headache), DIARRHOEA (diarrhea) and NASOPHARYNGITIS (cold symptoms) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-May-2021, SARS-CoV-2 test: positive (Positive) positive (all symptoms resolved on 25May2021).     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.   No concomitant medication was reported. The patient took cold medicine for treatment, not specified. No other treatment information provided.   Reporter did not allow further contact
Mother noticed a rash on both legs, fine papular rash symmetrical over the areas of the vaccination no rash on his body, no fever, he is a bit irritable. Papular acrodermatitis.
Moderna COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Moderna vaccine on 2/10/21 and 3/10/21. Presented to ED c/o AMS, disoriented and nonverbal. Anorexic and only responsive to pain. Pt found to be hypotensive and hypoxic in ER  despite 1L NS via EMS en route. No vomiting or diarrhea. Admitted for sepsis 2/2 to COVID and UTI. Went to septic shock and acute respiratory failure. Continued to worsen and transition to comfort care. Tx'd w/decadron and cefepime. Pt expired on 7/28/22.
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 31-AUG-2017, the patient was vaccinated with improperly stored VARIVAX lot # M018436 and expiration date on 13-APR-2018, subcutaneously (dose was not reported) for prophylaxis; which was reconstituted with properly stored sterile diluent (MRK). The doses of VARIVAX were exposed to a temperature excursion of 15 degrees Fahrenheit (°F) to 46 °F (19°F) during a time frame of 10 minutes which was detected by the data logger. There was no prior temperature excursion, no adverse events were reported and no product quality complaints were present. This is one of the two reports received from the same source. Sender's Comments: US-009507513-1709USA013473.
injection site pain; tiredness; headache; muscle pain; chills; joint pain; fever; injection site swelling; injection site redness; swollen lymph node; feeling unwell; This is a spontaneous report received from a non-contactable consumer, the patient. A 70-years-old non pregnant female patient received first dose of BNT162B2 (COVID-19 mRNA VACCINE BIONTECH; lot number: EN6206) via an unspecified route of administration in right arm on 10Mar2021 at 14:15 as a single dose for COVID 19 immunisation. The patient past medical history was breast cancer and patient had fruit allergy Kiwi. The concomitant medications were included Pravastatin (MANUFACTURER UNKNOWN) for unknown indication and unknown date and unknown if ongoing, Amlodipine-Benazepril (MANUFACTURER UNKNOWN) for unknown indication and unknown date and unknown if ongoing, Levothyroxine (MANUFACTURER UNKNOWN) for unknown indication and unknown date and unknown if ongoing. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. On 11Mar2021, at 10.00 the patient experienced on injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever, injection site swelling, injection site redness, swollen lymph node and feeling unwell. The clinical outcome for the events injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever, injection site swelling, injection site redness, swollen lymph node and feeling unwell was resolved.   No follow-up attempts are possible. No further information is expected.
CoughWheeze & Nausea Vomiting Narrative: 1. First dose 19 Dec 2020: Left shoulder pain, nausea, some fatigue but on day 2, I suddenly had a sob (moderate) and chest tightness which lasted for about 1.5-2 weeks. I had to use my inhaler mores often that I would had liked to but I think that it triggered my asthma. I still have to use it more frequently but not like the first to weeks (abnormal since I was using it less before). 2. Second dose 7 Jan 2021: Mild shoulder pain, next day with moderate chest pain, minor chest tightness and moderate fatigue. Pain without any other symptoms except for once mention. Pain last it about 1.5 weeks. Doing great now, except for number 1 above.
2y.o. 3 mos male with redness,hard swelling and tenderness to injection site consistent with sterile cellulitis secondary to injection. patient given keflex for 3 days with a recommendation for benadryl and HC topically. will f/u with PCP if worsens.
Diarrhea; loss of appetite; dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Oct2021 (Lot number: FF2589) at the age of 29 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "if covid prior vaccination: Yes" (unspecified if ongoing). Concomitant medication(s) included: CRANBERRY; VIT D3; FISH OIL. Vaccination history included: Bnt162b2 (Dose Number: 1, prev dose lot number: FF2589, prev dose vaccine location: Left Arm, prev dose administration time: 11:00 AM), administration date: 18Sep2021, when the patient was 29 years old, for Covid-19 immunization. The following information was reported: DIARRHOEA (non-serious) with onset 11Oct2021 06:00, outcome "not recovered", described as "Diarrhea"; DECREASED APPETITE (non-serious) with onset 11Oct2021 06:00, outcome "not recovered", described as "loss of appetite"; DIZZINESS (non-serious) with onset 11Oct2021 06:00, outcome "not recovered", described as "dizziness". Therapeutic measures were not taken as a result of diarrhoea, decreased appetite, dizziness.  Additional information: There was no other vaccine in four weeks. Other medication in two weeks included Cranberry supplemnt, vitamin d3, fish oil, and pre. The patient was not covid tested post vaccination. The patient had no Known allergies.   No follow-up attempts are possible. No further information is expected.
Immediately felt numbness on R side of face and like cotton balls R side of throat. Fever, chills, next day - also arm was red and swollen- needed antibiotics 2 days later and another doc visit-was disoriented - felt drugged- 1 month later and my arm still sore. I know 3 other people had adverse effects @ same doc with pneumonia shots.
abdominal pain; Diarrhea; fever; headache; chills; This is a spontaneous report from a non-contactable other hcp (Patient). A 38-years-old non- pregnant female patient received BNT162B2 (COMIRNATY; Formulation: Solution for injection, Batch/Lot Number: was not reported) via an unspecified route of administration, administered in Arm Left on an unspecified date as dose number unknown single for COVID-19 immunization. Medical history was reported as none. No other vaccine was given in four weeks. No known allergies were reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. No other concomitant medications were given in two weeks. On 05Feb2021 07:00 the patient experienced abdominal pain, diarrhea, fever, headache and chills. Patient did not receive any treatment for the events. The outcome of the patient was recovering.   No follow-up attempts are possible. Information on the lot/batch cannot be obtained. No further information is expected.
Vertigo; Psoriasis flare up; COVID-19; Swelling arm at injection site; Red line arm at injection site; Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo), PSORIASIS (Psoriasis flare up), COVID-19 (COVID-19), INJECTION SITE SWELLING (Swelling arm at injection site) and INJECTION SITE ERYTHEMA (Red line arm at injection site) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced VERTIGO (Vertigo), PSORIASIS (Psoriasis flare up), COVID-19 (COVID-19), INJECTION SITE SWELLING (Swelling arm at injection site), INJECTION SITE ERYTHEMA (Red line arm at injection site) and INJECTION SITE PAIN (Pain at injection site). At the time of the report, VERTIGO (Vertigo), PSORIASIS (Psoriasis flare up), COVID-19 (COVID-19), INJECTION SITE SWELLING (Swelling arm at injection site), INJECTION SITE ERYTHEMA (Red line arm at injection site) and INJECTION SITE PAIN (Pain at injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.         No concomitant medication was reported. No treatment medication was reported.  On unknown dates, the patient experienced COVID-19, psoriasis flare up, vertigo, swelling arm at injection site, red line arm at injection site and pain at injection site.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  The reporter's causality for the events of COVID-19, psoriasis flare up, vertigo, swelling arm at injection site, red line arm at injection site and pain at injection site was not provided for Humira.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Information has been received from a nurse concerning a 2 year old male with no pertinent medical history and a drug reaction/allergies to amoxicillin who on 16-OCT-2003 was vaccinated SC in the right thigh with a dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. The rash developed 3 days (on approximately 17-DEC-2004) after an influenza vaccination (manufacturer unknown) on 14-DEC-2004. The patient was seen in the office on 28-DEC-2004 with a rash that was present for 2 weeks. The rash was described as having a dermatomal distribution initially in the right axillary area that spread toward the sternum and did not cross the mid-line. The rash had multiple lesions numbering 4 dozen and was concentrated in the axillary area. The rash was accompanied by cough and congestion with mild stridor, with a mild fever for 3 days. The rash was described as a zoster rash. On 04-JAN-2005 the patient was seen in the office for a rash that developed a few days prior. This rash was described as a blotchy, burgundy colored rash in the lower extremities, non-raised and non-papular. It was unclear if this rash was related to a recent viral illness. The patient's father had a similar "type illness" while in another country due to exposure to several family members in another country that were ill. No other information was reported. There were no lab diagnostics studies performed. The outcome is reported as recovered. There was no product quality complaint. Additional information has been requested.
eyes red-swollen like had been crying; red rash on forehead; no redness or swelling noted; congested nose; mom states SOB when asleep but sounds congested; eating OK; given med for cold & sinus sx;
92-year-old male nursing home resident recently diagnosed with Covid 3 days ago rapid test antigen test is positive here in the ER history of dementia presents to the hospital because of a fall.  Negative trauma work-up.  Patient's oxygen saturation was 90% on room air when he got here.  ER put him on 2 L and is 98% now.  Patient is not a good historian because of his dementia. Troponin 0.04.  No lymphopenia.  White count is normal.  Chest x-ray is normal.  Hip x-ray is normal.  CT head, CT cervical spine is normal.  EKG reveals rate controlled A. fib.  Patient has a history of chronic A. fib. Patient was admitted to medical floor, due to presenting symptoms MRI brain was obtained.  MRI did show evidence of recent ischemic change to posterior left frontal or parietal lobe.  He was started on aspirin in conjunction with home atorvastatin and Xarelto.  PT and OT were consulted, patient did have difficulty participating in PT, his understanding is fine however his hearing is significantly impaired and I think it was more of a communication issue rather than an understanding of directions issue.  On my exam today I was able to write out my questions and his diagnostic findings, he was able to answer questions appropriately and verbalized understanding of findings he was able to follow commands without difficulty.  Neurology was consulted, await their recommendations.  Once cleared by neurology plan for discharge for further PT.    Per daughter, patient does not appear he has had any significant change in his understanding though he does have continued weakness.  This is likely attributed to both covid and his recent stroke, after long discussion she would like to pursue further PT and strengthening.
body discomfort/pain, fever, fatigue, joint pain, nausea, muscle aches Narrative:
Patient was seen 1/13/17 for 12mth WCC and also received vaccinations. Seen 1/23/17 for viral exam then from possible MMR received 10 days prior to visit w/o fever and rash at that visit.
45 minutes after shot: left half of face went numb (same reaction as 1st dose). Felt like I was coming home from the dentist office after being numbed up.  The following day around 9am: mild headache and stomach became upset. Stomach became worse over the day. Couldn't eat for fear of throwing up. Called in sick to work for the following day. 45 hours later: migraine and stomach still upset but I don't feel like throwing up.
Swelling and redness on the injection site after 7 days from dosing. No pain.
9/6/12 Pt was seen for allergic reaction to 2nd varicella shot at our clinic. It was red, swollen at injection site. 6 x 7 cm lump site, felt warm no fever. Treatment was children's BENADRYL & ice pack to put on arm when needed.
COvId Vaccine Breakthrough Case  J&J Dose 5/8/21 (203A21A) COVID Positive 12/1/21  12/6/21: Patient is a 46-year-old male, only medical history is new onset diabetes which was diagnosed 5 days ago.  He was vaccinated (J&J) for COVID 7 months ago.  He does not smoke/vape.  Pt presented to the ED on 12/1/2021 and was diagnosed with COVID pneumonia.  He was discharged with Rx for Azithromycin.  Reports he has been at home self-quarantining and resting over the last 5 days. Complains of fatigue and weakness x5 days, SOB and persistent cough started this AM.  Came to the ED.  On arrival, the patient's SpO2 was 77% on room air.  He was tachypneic 20-30s.  Heart rate 90-110s.  Labs were significant for sodium 128, glucose 296, lactic acid 3.1, LDH 334. CXR showed patchy infiltrates throughout both lungs, worse since 12/1.  In the ED he was given 1 L of normal saline, 125 mg Solu-Medrol, 1g Rocephin, and 500 mg Azithromycin. He was also given an extended DuoNeb.  I discussed the patient with Dr., and he recommended admission to ICU. Nursing supervisor notified. Dr. also recommended adding a CRP, and if the CRP is greater than 15, he will be given Actemra. Same ordered.  12/11/21: Patient is a 46-year-old male who was admitted in hospital on 12/06/2021 and treated COVID-19 pneumonia. On arrival to the ED, the patient's SpO2 was 77% on room air. He was noted with respiration 20-30s along with tachycardia. He was initiated on supplemental oxygen requiring up to 11 L. Patient's blood work was significant for sodium 128, glucose 296, lactic acid 3.1, LDH 334. CXR showed patchy infiltrates throughout both lungs. Patient was admitted into ICU and pulmonology consulted. Patient was treated with Actemra, remdesivir, dexamethasone and IV antibiotics. Patient's symptom improved and he was able to transfer to the medical unit. Completed a home oxygen walk and will require 1 L at rest and 3 with activities. RN care coordination set up patient with visiting nurses and patient to discharge with COVID safe home.  Patient completed his remdesivir and IV antibiotics treatment. Today patient denies shortness of breath, palpitation, abdominal pain, chest pain and states feeling much better. Patient has a new onset diabetes and was recently metformin. Patient's current over A1c 13, will resume his metformin and add Lantus.  Advised patient to follow-up with his primary care provider for repeat A1c. He voiced understanding and he was provided with education diabetes management. I reviewed test findings with the patient and answered all of his questions.  He is being discharged in improved and stable condition.
Information was received on 26-MAY-2017 regarding a case in litigation concerning a male (age not reported). Medical history, concurrent conditions and concomitant medications were not reported. On or about 01-JUN-2012 the patient received a dose of ZOSTAVAX (lot # and dose not specified) as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 25-AUG-2016 the patient was treated for a vesicular outbreak that was diagnosed as severe shingles. The patient was treated by a physician and was prescribed hydrocodone-acetaminophen for management of his painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
This spontaneous report was received from a pharmacist concerning to a 66 year old male patient. Medical history and concurrent conditions were not provided. On 10-OCT-2017, the patient was vaccinated with a dose of PNEUMOVAX 23, 0.5 ml, intramuscularly (lot# and the expiration date were not reported) for prophylaxis. Other suspect therapies included influenza virus vaccine (unspecified) high dose. Concomitant therapies included insulin glargine (LANTUS) and other unspecified medications. On the same date and within 24 hours, the patient experienced unspecified side effects (adverse event). The patient was seen by pharmacist, but did not receive any treatment for the event.   At the time of reporting, the outcome of adverse event was reported as not recovered. The relatedness between the therapy with PNEUMOVAX 23 and the adverse event was not reported.
I shook uncontrollable for about 30 minutes and felt a chill. I was about to go to ER when the symptoms calmed down.
Vaccine administrator was administering a child's Pfizer vaccine today and forgot to dilute it with sodium chloride 0.9% first.
A sharp nerve like pain with administration. THe pain continued down the arm the next day and the following day.  It made my joints, muscles  and body ache along with fatigue.  By second day the soreness down length of arm continues but body wide aches are subsiding.
Immediately following vaccination, started having itchy tongue, ears and mouth.  Rash emerged on left chest and shoulder with muscle pain.  Left arm became numb, rash at injections site, migraine, numb lips and mouth.  Persisted and progressed to vomiting and diarrhea, tachycardia and tachypnea.  On 1/14, petechiae around both eyes, widespread muscle and joint pain, tachycardia and tachypnea persist, unable to lift left arm, itchy face, nose and throat.  1/15 Tachycardia persists, migraine, diarrhea, sudden onset vaginal bleeding. 1/16 elevated blood pressure, tachycardia and tachypnea, found unresponsive in bed by my husband and taken to the emergency room.
Starting at approximately 08:45PM on the night of the shot 03/29 (6 hours after the shot) and persisting until about 03/31 between 2am and 4am, I had muscle aches and joint aches with occasional shooting pain in the elbow joints. My arm was also sore.   The effect cleared up while sleeping. I had sweated enough to dampen my clothes and sheets. Upon waking, I felt fine.
Have not been ill in YEARS. Was forced to take vaccine under threat of unemployment and homelessness-for my health. Went to bed early, woke up at 9:30, it felt like I had been thrown off of a building. Took hot epsom salt  bath, went back to bed and then violent chills. Got up and ate some hot soup, then back to bed for a round of cold sweats. Intermittent chills and cold sweat all night long. I signed an electronic waiver, but it was done under duress by threat of exile. Plenty of responsible parties involved in forcing this disease on me when I was perfectly healthy. Which one(s) are going to compensate me for the damage to my body?
A report has been received from a Health Professional concerning a 5 year old, male subject, who had been receiving FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on 02-DEC-2014. the reporter stated that they inadvertently gave expired FLUMIST to three patients on 02-DEC-2014. At the time of reporting, the event of inadvertently gave expired FLUMIST  to three patients was improving. The report was considered to be non-serious.
Notice bumps 3 days ago.  Itchy rash pt checked and found blisters have gotten bigger.
I am diabetic on a CGM and insulin pump. My blood sugar started to rise mid-afternoon and I couldn't get it below 200 despite giving myself increased amounts of insulin. It was up to 289 at bedtime. I count carbs and was very careful about what I ate yesterday. This morning I was back down to 169 when I got up, but I had increased my basal rates during the night. Second event that I'm not sure is related, but FYI, last evening I got some sharp pains in my left hip and continual aching in my left buttock while sitting watching TV. It continued until after I went to bed. It's back to normal this morning.
Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Fever-Mild, Additional Details: Pt reported to pharmacy ~9:55am on 8/3/22 and stated that she had fever and rash after vaccine. She presented red areas of skin on face, neck and left lower flank. Stated the areas "are itchy and hurt like hell when scratched." Fever was on 08/02 then went away. No difficulty breathing . pt contacted doc, on allegra now, will report to doctor 8/4/22.
Patient reports Pfizer booster  vaccine was given on 2/14/22. Vaccine administered on to left arm. Patient reports localized pain to axilla with a painful bump under and observed the following day after vaccination Skin intact and without erythema She reports pain with movement  Pain reported 7/10 and taking Ibuprofen that has been prescribed - no improvement
p/vax generalized & pruritic maculopapular rash w/some vesicles;