chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a RN concerning a 79 year old Caucasian female with a history of arrhythmia, tachycardia, high cholesterol, tinnitus, diarrhea, diverticulosis and breast cancer who on 07/01/03 in the AM was vaccinated with a second dose of pneumococcal vaccine 23 polyvalent (Lot # 645255/1212M)(IM), in the left deltoid. Concomitant therapy included digoxin (Lanoxin), alprazolam (Xanax), polyethylene glycol 3350 (Miralax), letrozole (Femara), and calcium (unspecified). It was also noted that the pt had allergies to "brain scan dye", erthromycine (E-mycin), cefuroxime sodium (Keftab)(diarrhea), tamoxifen, meperdine HC1 (Demerol), disopyramide phosphate (Norpace) and cisapride (propulsid). On 07/01/03 the pt experienced left tricep and bicep warmth and erythema also described as "red swollen down to elbow". The pt sought medical attention. The pt was treated with Benadryl, antihistamines and ice/cool compresses (PRN). The reporting nurse inquired if there had been any concerns with this lot of pneumococcal vaccine 23 polyvalent (Lot # 645255/1212M). It was also noted that on 07/21/03 the pt developed a numb hand and it was reported that "don't know if it is related." It was reported that the pt recovered. The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. It was also reported that another pt had similar symptoms (WAES # 0307USA00308).  Additional information has been requested.
2-21-07 Child to MD for 1 yr well child visit-had red bumps around his waist and on his hand, 2 on one foot. MD told mother, possible insect bite-No prescription recommended. 2/22/07 came to PMD for vaccines-received 2 vaccines, Varicella and MMR. 2/27/07 developed rash-red raised, fluid filled-on back, chest, back of neck-Too numerous to count, no cough-ax. temp 100 deg. Had increased temp 3-1,2,4,4, no fever 3-5. Child has nasal congestion, RN advised Motrin to comfort. MD to report rash and having vaccines. She will call 3/7 MD not in today-RN told mother to call MD office and speak with MD on call. Instructed signs and symptoms severe allergic reaction and call MD.  Take to hosp if this occurs, said she will do this. Mother will call Rn 3/7 with update. 3-7-07 mom and child with PMD for app. child saw MD-was told the rash is consistent with the MMR. Side effect after having vaccine, rash subsiding.
Patient began vomiting at 0630 and continued to do so every 5-15 minutes until approximately 1200. She presented no fever or other symptoms. After that time she recovered fully and was back to normal the following day.
Extremity erythema/induration. Reports hives, fever 101.4 (afeb at 24). No respiratory complaints.
Significant fogginess of brain which has only worsened and is still lingering to now (4/18/21). Simultaneously this is mixed with fatigue regardless of how much sleep I get or water that I drink. Less frequently I have symptoms like eyes burning (similar to bad allergies), slight dizziness, minor headaches, and minor body aches. The fatigue and brain fog are by far the worst and still persist, the others listed are minor but still come and go in small amounts. On Wednesday (4/14) I took Zyrtec (10mg tablet) to help focus throughout the day then one ibuprofen tablet (200mg) at night, and on Friday (4/16) I only took the Zyrtec. Since then I have not taken any medications. The symptoms were alleviated by the medication but without them all symptoms come and go to varying degrees throughout the day and worsen by night time.
After 10 minutes of receiving vaccine, patient reported that his left side of face felt a little numb. He also complained of feeling dizzy. Patient was brought to exam room. BP was elevated 160s/90s. Stroke ruled out, no drooping noted in face. Patient able to move upper extremities fully and symmetrically. Patient was observed for 15 minutes. BP rechecked. BP decreased to 131/80. Patient observed for 15 more minutes. Patient reports cessation of numbness and dizziness. Patient was able to walk out of clinic alert and without assistance. Patient encouraged to make appointment with PCP to check for undiagnosed HTN. Patient denied having a PCP. Encouraged to find PCP or sign up at clinic.
Shortly after vaccine was given patient c/o dizziness, diaphoresis, and nausea. given Benadryl with some relief.  Also c/o numbness around lips, chin, and cheeks but subsided as observation continued.
lt leg above knee/below diaper area not red but swollen-pulling on leg but not fussy;
FEVER, COUGH, LETHARGIC, STOMACH PAIN, RUNNY NOSE AND CHEST CONGESTION.
A RN nurse reported that 15 pt's developed symptoms of multiple sclerosis following vacc. w/Hepatitis B vaccine (Recombinant). FDA contacted reporter, who said she was not reporting cases but asking MSD is there assoc.of MS /w the vaccine?
Afib; Feeling uncomfortable; Blood sugar was around 150, which is higher than her normal levels; A spontaneous report was received from a consumer who is 76-year-old, female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced atrial fibrillation, feeling uncomfortable, and increased blood sugar.  The patient's medical history included diabetes and atrial fibrillation. Concomitant medications were not reported.  On 02 Jan 2021, the patient received their first two planned doses of mRNA-1273 (Batch number: 025LZ0A) intramuscularly in her right arm for the prophylaxis of COVID-19 infection.  On 02 Jan 2021, the patient experienced heart beating very fast and feeling uncomfortable; it lasted for a few hours. She stated it was atrial fibrillation, she had a diagnosis of this, and it only lasted a few hours. The patient also stated that her blood glucose was 150, which was higher than normal.  Treatment for the events was not provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of events, increased blood sugar, was considered not resolved. The outcome of the events, atrial fibrillation and feeling uncomfortable, was considered resolved.; Reporter's Comments: This case concerns a 76 year-old female patient with a significant medical history of atrial fibrillation and diabetes, who experienced a serious unexpected event of Atrial fibrillation and non-serious unexpected events of Discomfort and Blood glucose increased. The events occurred one day (same day) after first dose of mRNA-1273, lot # 025LZ0A. Treatment was not reported. Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded. However, patient's medical history of atrial fibrillation and diabetes were considered strong confounders.
Aches like working out too much/Body ache; Diarrhea; Intermittent fever; This spontaneous case was reported by a physician and describes the occurrence of PAIN (Aches like working out too much/Body ache), DIARRHOEA (Diarrhea) and PYREXIA (Intermittent fever) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Hidradenitis suppurativa.    No medical history were provided by the reporter.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced PAIN (Aches like working out too much/Body ache), DIARRHOEA (Diarrhea) and PYREXIA (Intermittent fever). At the time of the report, PAIN (Aches like working out too much/Body ache), DIARRHOEA (Diarrhea) and PYREXIA (Intermittent fever) had resolved.        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 medications were provided.  Treatment medications were unknown.    Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: On 06-MAY-2021, received updates to event information, reporter opinion of causality (changed from drug discontinued to Unknown), suspect drug information and narrative description. The event  "Body ache" was amended to "Aches like working out too much/Body ache ".
Flu like symptoms - fever, joint aches, H/A, abd cramping, nauseated. Started 7 pm Thursday ended in 24 hours 6/3/10.
Vomiting, Nausea, Diarrhea, Chills, Headache
Presented 5/13 to Hospital.  Presented to Hospital on 5/13 with one week of symptoms including cough, dyspnea, diarrhea. COVID-19 testing was positive on 5/8.   Treatments prior to arrival included remdesivir and dexamethasone, started 5/13.  She was also placed on pulse dose steroids 1000 mg/day methylprednisolone given her history of ground glass lung opacities in 2018.  Progressed to high-flow nasal cannula, then BiPAP on 5/14, and was intubated on 5/17.   Paralysis and proning initiated.  Transferred to another hospital for possible VV ecmo candidacy. Patient with severe acute respiratory failure d/t covid who has failed treatment with the ventilator despite paralysis and proning.   CTS asked to place patient on VV ECMO.    5/20/21 1135am  initiated ECMO Patient is a 50yr old female with past medical history of hypertension, asthma, OSA and obesity BMI 41.5 who presented to hospital on 5/13 with progressive cough and shortness of breath for about a week.  Of note, patient also has a history of respiratory failure presenting with ground glass opacities on CT scan in 2018 with unclear etiology despite bronchoscopy and serologic studies which resolved with high dose corticosteroids.  Patient recently tested positive for COVID on 5/8 and received johnson and johnson vaccine in April. Patient was admitted on 5/13 and treated with decadron, remdesivir and tocilizumab.  Course complicated by progressive respiratory failure requiring HFNC followed by Bipap and ultimately intubation on 5/17.  Due to elevated d-dimer, lower extremity dopplers were obtained which were negative, however a heparin gtt was initiated. Course further complicated by cold left lower extremity; arterial duplex demonstrated distal popliteal artery thormbus extending into the peroneal, anterior tibial and dorsalis pedis arteries. therefore heparin was switched to argatroban and a HIT panel was sent.  On 5/19 patient continued to decline despite paralytic and pronning.  Patient transferred to ICU for further level of care and VV ECMO evaluation. On arrival patient was started on veletri; however due to continued respiratory decline a shock call was placed for VV ECMO and patient cannulated for VV @ 1200. Cannulation was difficult and patient was felt to have an IVC thrombus as clot was seen going into the ECMO circuit during cannulation. Post cannulation she developed worsening septic shock and DIC. She received 2uprbc, 1unit cryo, 1 platelet, 2 FFP, 5 liters crystalloid and 1L albumin. Blood cultures positive for GPC in clusters. Escalating vasopressors (Epi/NE/vaso) and ongoing hypoxia family opted to change code status to DNR. Patient then continue to have worsening hemodynamic instability and went into PEA and ultimately asystole. She was pronounced deceased at 1815. Family was en route already due to her instability thus will be notified of her passing once they arrive. Dr. was notified of patients death.
Patient's wife said he had a fever, felt like someone beat him over his entire body (sore) and that caused him to stay home from work.
a patient was given only the liquid component of Pentacel/No AE; Initial information was received on 28-Jan-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a five month old patient who received only the liquid component of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) and PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE) for prophylactic vaccination.  On 24-Jan-2020, the patient received second 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (Box Lot- UJ115ABA Expiration date: 30/11/2020, IPV/DTAP Lot- UJ056AAA Expiration date: 27/10/2020 ACTHIB Lot- UJ115AB Expiration date: 23/11/2020) via intramuscular route in the right thigh for prophylactic vaccination.  It was a case of actual medication error due to inappropriate reconstitution technique.  No adverse event was reported (well child).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.
Patient with high fevers to 103, confused/encephalopathic, nausea, vomiting, diarrhea, thrombocytopenia, AKI.
Started evening of 10/8/12 - she began itching, fever & chills, rash on upper arms & leg. Went to (medical walk-in) given an injection of DECADRON, ZANTAC 150 mg. po BID x 5 days & Methylprednisolone 4 mg. po dosepak.
34yo Male complains of a lymph node persistent for several months, which first presented several days after his 2nd Moderna COVID-19 dose.   Physical examination remarkable for a pronounced soft, mobile, and non-tender 2x2cm supraclavicular lymph node above the midshaft left clavicle.
Severe COVID-19 pneumonia with acute hypoxemic respiratory failure diagnosed 3/12/2021, per hospital discharge summary: On admission patient requiring 10 L nasal pendant to maintain adequate oxygenation.  She was admitted to the facility.  Chest x-ray showed diffuse interstitial thickening and mild bilateral patchy airspace opacity.  Inflammatory markers for notable for CRP of 120, D-dimer 805, ferritin 276.  She was treated with dexamethasone (and prophylactic ivermectin) and Lovenox 1 mg/kg twice daily.  Remdesivir was deferred given the onset of symptoms > 5 days PTA.  She had good response to treatment and over the next 3 days her oxygen was tapered off and she had very good symptomatic improvement.  At time of discharge she had minimal symptoms and had an ambulatory O2 sat greater than 94% on room air."
Information has been received from a registered nurse concerning a 87 year old patient who on 01-DEC-2009 was suppose to receive ZOSTAVAX (Merck) (MSD) and was inadvertently administered VARIVAX (Merck). No adverse effect was reported. Follow-up information has been received from a receptionist who indicated that a registered nurse stated that the patient received VARIVAX (Merck) and ZOSTAVAX (Merck) (MSD). Additional follow up information had been received from a registered nurse who stated that on 01-DEC-2009 the patient received VARIVAX (Merck) (Lot # 662581/0058Y) instead of ZOSTAVAX (Merck) (MSD). The nurse also stated that this was due to a medication error and not product confusion. It was also reported that the patient after receiving the VARIVAX (Merck) vaccination received ZOSTAVAX (Merck) (Lot # 664630/0837Y). No adverse effect was reported. Additional information is not expected.
Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Medium, Additional Details: Patient did not have reaction immediately post-vaccination during observation period. Experienced later on same day and following day. Pt has generalized itching/rash/hives causing mild discomfort.. Counseled on use of OTC pain medications, ice and antihistamines. No report of symptoms related to anaphylaxis such as swelling of airways/lips/throat/tongue. Advised to reach out to doctor for further attention.
PATIENT WAS 17 YEARS OLD AT THE TIME OF RECEIVING MODERNA COVID19 VACCINE INDICATED FOR 18 AND ABOVE.
Widespread body rash. Received shot in left arm, spotty rash on left arm observed. Rash/welts observed on face, entire right arm. Reports entire trunk with same symptom.
to ER c/o sore throat, headache and nasal congestion x3 days.  myalgias, cough
Discovered by a third nurse who removed an influenza vaccine syringe and then in double-checking the drug noticed the drug name on the syringe.
Information has been received from a RN concerning a pt who on 15Apr97 was vaccinated with a dose of varicella virus vaccine live (lot 622625/0085E). Subsequently, on 14May98, the pt developed chickenpox. The pt was seen in the office. The reported also indicated that 30 pts were vaccinated with varicella virus vaccine live and developed chickenpox (WAES0409USA00600, WAES0409USA01045, WAES0409USA01046, WAES0409USA01047, WAES0409USA01048, WAES0409USA01049, WAES0409USA01050, WAES0409USA01051, WAES0409USA01052, WAES0409USA01054, WAES0409USA01055, WAES0409USA010456, WAES0409USA01057, WAES0409USA01058, WAES0409USA01059, WAES0409USA01060, WAES0409USA01061, WAES0409USA01062, WAES0409USA01063, WAES0409USA01064, WAES0409USA01065, WAES0409USA01066, WAES0409USA01067, WAES0409USA01068, WAES0409USA01069, WAES0409USA01070, WAES0409USA01071, WAES0409USA01072, WAES0409USA01073, WAES0409USA01074). No further information is expected.
The night of that he recieved his Tdap, Hep A, and Menactra he c/o stomach ache and ran 103 fever. For 5 days he ran 102-104 fever, had chills, headache, and backpain. No coughing, no sore throat and no rhinorrhea.
Patient complained of dizziness. BP @ 5:35 154/81, 5:45 172/76, @ 5:50 198/75. Patient was sent to Urgent Care for further medical evaluation
Fever, chills, sweats, malaise, general ill feeling, commencing approximately 15 hours after injection. Illness lasted approximately 36 hours.
Pain, itchy, swelling, red, warm on injection site after the shot and lasts more than one week (pain went away in coup days).
I also had my eye ball that was swollen and painful; I also had my eye ball that was swollen and painful; increased pressure in left eye; Vision started to worsen; headache for half a day; slight pain in arm; This is a spontaneous report from a contactable consumer or other non- health care professional (Patient himself). A 71-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE Formulation: Solution for injection Batch/Lot number: not reported; Expiration Date: Unknown) via an unspecified route of administration, in arm left on 03Mar2021 at 11:30 as single dose for COVID-19 immunization. Patient states the lot number on the vaccination card is EN620 and the last digit is either a 5 or a 3. H is unsure of last digit of lot number. Patients Medical history and concomitant medications were not reported. On 03Mar2021 patient experienced slight arm pain. Patient stated that on 04Mar2021 patient experienced headache for half a day and on 05Mar2021, two days after he got his first shot he had problem with his vision, it was dimmer and dimmer. It got progressively worse during that time up to 30 days after he could not see well in the kitchen he needed to use a flash light. Now its back to normal. Patient also had his eye ball swollen and painful, it also started after the 1st dose. Patient reported that he had what he suspects is an adverse reaction to the Pfizer COVID Vaccine dose one, of course he was not sure. Basically about two days after getting the first dose Pfizer COVID Vaccine his vision started to worsen. Vision started to worsen: It first became blurry then darker and darker and darker until central vision, couldn't see across caller's kitchen. Caller needed a flashlight to do cooking, particularly couldn't see liquids, levels of liquids. Increased pressure in left eye: Also with that there was increased pressure in left eye, left eye ball would swell, and it would be painful, and then it would go away after about 30 seconds. Vision started to worsen: Patient states this began about 2 days after receiving the first dose Pfizer COVID-19 Vaccine and continued about 30 days after. Patient states he was referring to when he was talking about not being able to see well enough to cook. Then overnight, the next morning everything cleared up and went away. Vision was back to normal or back to normal for the patient. The patient received second dose of bnt162b2 on 24MAR2021. Outcome of event pain in arm and headache was recovered on an unspecified date in 2021 and outcome of event problem with his vision was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pt. received HBV on 5-19-11. She woke up this morning & noticed her (Rt) hand was swollen. (Rt) upper arm is swollen at shot area. No redness observed. No other c/o problems were voiced.
The RSV vaccine was supposed to be administered but only the diluent was given, patient was not experiencing any symptoms but the wife mentioned he had stomach upset yesterday 11/19/23
pt recvd vax;lt arm swollen & red;erythemia from mid deltoid to 3" below the elbow;erythemia radiated in a blotchy pattern to anterior of lt arm;lt arm was warm & tender to touch;
there was no adverse reaction, however the Moderna monovalent was administered in error when the Bivalent was indicated and the intended vaccine.
The vial expiration date was 13-Oct-2021 and date of vial placed in refrigerator before administration was on 21-Oct-2021; Dose was given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date) and PRODUCT STORAGE ERROR (The vial expiration date was 13-Oct-2021 and date of vial placed in refrigerator before administration was on 21-Oct-2021) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial expiration date was 13-Oct-2021 and date of vial placed in refrigerator before administration was on 21-Oct-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date) and PRODUCT STORAGE ERROR (The vial expiration date was 13-Oct-2021 and date of vial placed in refrigerator before administration was on 21-Oct-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The health care professional reported that there was a confusion between the expiration date printed in the carton and the expiration date when the quick response code was scanned. It was reported that patient had no temperature excursion and no adverse event.  No treatment medications were reported.   This case was linked to MOD-2022-491837 (Patient Link).
very dizzy  felt like I was going to faint, could not shake it, was at work went home. went to bed and slept 10 hours  outcome= was fine when I woke up
External COVID + on 8/1; breakthrough admission on 8/5 after two vaccines Moderna 4/8/21 Lotz# 025B21A;  Moderna 5/6/21 Lot# 005C21A
Pt was having tonic type of seizure, which are stiffening or tightening of all muscle groups; the head or eyes turned inward, right arm stretched out.