chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sepsis; UTI; shingles; severe headaches; A spontaneous report was received from a 90-year old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced UTI, sepsis, shingles, and headaches.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 04 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number not provided) for prophylaxis of COVID-19 infection.  On 05 Feb 2021, the patient began experiencing severe headaches. On 11 Feb 2021, the patient developed a severe urinary tract infection and had to be hospitalized. The patient broke out with shingles and now has sepsis. The patient is reported as being conscious, but not responding. No treatment information was provided.   The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable.  The outcomes of the events, UTI, sepsis, shingles, and headaches, were not provided.; Reporter'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.
There is no additional AE or PQC associated with this case; given MMR-II intramuscularly vs. subcutaneously; Expired vaccine administered (Expiration date 31-MAR-2018); This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications and previous drug reactions or allergies was reported.  On 05-NOV-2020, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) intramuscularly, once, for prophylaxis (lot # S039309 was verified to be valid, expiration date reported as 04-DEC-2021, but upon internal validation established as 31-MAR-2018), (strength and dose were not provided).  The patient did not experience any additional adverse reactions. The reporter wanted to know if there was any safety data that they need to know about the intramuscular versus subcutaneous vaccination with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II).
Intense itching,, hives  and burning sensation on arms, legs, stomach, chest., and back. daily starting 10 days after vaccination. Episodes occur several times per day and every night until I take a Zyrtec 24. After 24 hours pass, the itching and hives recur.
pt devel fatigue, low grade fever, & rash dx @ the time as muscular contagiosum;pt also devel spider angiomas on the lateral chest wall;devel acute sinusitis;sed rate 29;intermittent eruptions rash chest;lupus;
Patient was given a 2.5ml dose instead of a 0.5ml dose of the Moderna bivalent covid booster.
This medically confirmed spontaneous report (initial receipt: 28-Sep-2012) concerns a female patient. On 27-Sep-2012 the patient received AFLURIA (batch number: P59107) injection. Following vaccination, the patient developed injection site reactions. The reaction was described as being localised at the injection site 3 inches in diameter, red, hot and hard to the touch. The patient sought medical attention. The event outcome was recovering.
Case number PHEH2014US025111, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 40-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 19 Nov 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event was reported following this maladministration.
No additional AE; A patient was given VARlVAX intramuscularly; This spontaneous report was received from a physician (conflicting information also reported as pharmacist) referring to a patient of unknown age and gender. The patient concurrent conditions, pertinent medical history, concomitant therapies and drug reactions or allergies were not reported.  On 28-MAY-2021, the patient was vaccinated with a dosage of varicella virus vaccine live (oka/merck) (VARIVAX) dose 1, intramuscular (IM), (lot # T010298), (expiration date 24-MAR-2022) (strength, and dose were not reported) for prophylaxis; and on the same date, the vaccine was recontinued with sterile diluent/ vaccine lot # T005074, (expiration date 09-SEP-2022) (strength, dosage, route of administration were not reported) for prophylaxis (incorrect route of product administration). The patient did not experience any adverse event.
Silver dollar sized indurated raised, erythematous area approx 1.5 inch medial to DTaP injection site. Keflex antibiotic to treat.
After first 5 minutes after initial shot, legs started tingling. Then nothing after that. By 7:00pm after initial shot, fatigue set in, and then I fell asleep. No notable events until Second Shot. Day of second second shot, around 7:00 PM, fever/fatigue set in. Next day feeling fine. Today's date: 6/24/2021 at the time of writing this, heart feels abnormal, but not alarmingly abnormal. There is a flutter of a heartbeat occasionally.
The pt experienced a rash on the abdomen and was diagnosed with roseola. Rash appeared over entire body.
pt blood pressure dropped and pt felt faint.  Had pt lie on floor and took blood pressure at 1:20 was 112/73 and pulse of 49.  monitored pt and rechecked blood pressure at 1:25 was 117/86 and pulse of 61, at 1:30 was 91/53 pulse of 52.  gave pt salty potato chips and pt was drinking a dr pepper.  blood pressure at 1:35 was 126/82 and pulse of 58.  pt felt fine and sat in break room for another couple minutes then said he was fine.
Generalized urticarial/hives over entire body except face/head, itching, scratchy throat. Started 3 hours after receiving flu vaccine and progressed slowly within the next 24 hours. Seen in Employee Health on 10/25 8:00am and advised to start taking Benadryl 25mg and referred to Fast Track/ED for further treatment (she was not experiencing any additional systemic symptoms at that time (no problems breathing, swallowing, no edema/stridor- vital signs stable). Employee declined going to ED and when hives persisted and increased in intensity the following day and she started to complain of a scratchy throat- she finally agreed to be seen in Urgent Care/ED for further treatment. Received the following in ED-  Famotidine 20mg IM x 1, Methylprednisolone 125mg x 1, and Diphenhydramine 25mg x1 Sent home with following meds: Famotidine 20mg BID x 7 days, Prednisone 20mg BID x 7 days and Benadryl 25mg Q6hrs/prn (all po) The employee took Benadryl 10/25 with no relief and then was seen in ED on 10/26 and treated as above. Symptoms then took about 5 days to finally resolve- completed treatment with no residual symptoms noted.  Advised of Flu vaccine allergy and not to receive flu vaccine going forward.
1535  Pt coughed, which was noticed by RN.  immediately attended Pt as he began gently tapping his throat with occasional coughing.  Pt agreed that he wanted some water and was given an unopened bottle of water.  Pt's cough was becoming persistent and he began tapping his throat in a panicked fashion.  Pt immediately started to wheeze with respirations which became more intense within moments.  RN, grabbed one of the three Rapid Bags and removed an adult Epi Pen and gave it to the attending nurse, another RN. Pt slumped to the floor with the help of two nurses and sat slouched with legs in a V formation in front of him.  (Continued)
Pt to ED and found to be positive for COVID; COVID pneumonia and went into ARDS; later dx with Morganella pneumonia with acute exacerbation of CHF and a type 2 NSTEMI; ICU; BiPAP; left sided pleural effusion; developed left pneumothorax and required a chest tube; after procedure, pt remained unresponsive; GCS 3; transitioned to comfort care and he passed away in the hospital
Got the vaccine at 3pm on Friday, I could not sleep all night, I woke at 2am with chills and uncontrollable shaking.  I took my temperature in the morning and it was over 101.  I took tylenol but my fever never went below 99.9 all day.  No energy, stayed in bed all day.  Elevated heart rate, chills, breathing did not feel normal.  Body aches, headache, nausea, severe pain at injection site, today 5 days later, I still have underarm pain.   I had Covid in October and was told it was ok to get the vaccine as long as it had been 90 days since I was sick.  I felt like I had Covid again after having the vaccine.
within 24 hrs of injection patient developed redness and swelling of the entire right upper arm--pt was instructed to apply cool compresses qid and recheck in 24 hrs--pt did f/u in 24 hrs and swelling had resovled significantly
This spontaneous case was reported by a consumer and describes the occurrence of HAEMATOMA (Hematoma on bicep from shoulder to elbow), BURNING SENSATION (Burning Sensation) and ARTHRALGIA (Soreness in shoulder) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043L20A and 014M20A) for COVID-19 vaccination.   The patient's past medical history included Surgery (Patient had a surgery on that shoulder 4yrs ago never had any problem with that shoulder since then). Previously administered products included for an unreported indication: FLU VACCINE VII (have taken flu shots on either shoulder for over 20 years.). Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication. On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced BURNING SENSATION (Burning Sensation) and ARTHRALGIA (Soreness in shoulder). On 09-Mar-2021, the patient experienced HAEMATOMA (Hematoma on bicep from shoulder to elbow). The patient was treated with CORTISONE at an unspecified dose and frequency. At the time of the report, HAEMATOMA (Hematoma on bicep from shoulder to elbow), BURNING SENSATION (Burning Sensation) and ARTHRALGIA (Soreness in shoulder) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Patient initals were updated from P-P to D-S.
Patient is experiencing dizziness/vertigo randomly throughout the day resulting in a need to lay down and wait for symptoms to pass.  No history of this issue prior to vaccine.  Similar symptoms have been experienced by myself as well as my mother all following our booster shot.
Developed welt approximately 3/4" x 2" raised deep pink and hot. Left wrist itching. General feeling sluggish. Approximately 48 hrs later arm itching at site, hot, symptoms started to subside after 96 hrs.
Pt recvd 2nd dose of Engerix-B 10OCT90 & on 11OCT90 exp a localized rash, erythema, & swelling of deltoid region; Pt has 8mm erythematous vesiculation;
Information has bee received from a pharmacist concerning a female patient (age not reported) who was vaccinated (date not reported) subcutaneously with the first 0.5ml dose of PNEUMOVAX 23 (lot# 658074/0961U). Subsequently, the patient developed cellulitis. The patient had an office visit and received medical treatment with unspecified antibiotics and anti-inflammatories. At the time of this report the outcome was unknown. The pharmacist requested a lot check for PNEUMOVAX 23 (lot# 658074/0961U). A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. This is one of several reports from the same source. Additional has been requested.
hoarseness; Tightness in face; Tightness in throat; Tightness in neck; This is a spontaneous report from a contactable consumer. A 46-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot Number: En6203), dose 1 via an unspecified route of administration, administered in left arm on 24Feb2021 at 15:30 (at the age of 46-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included diabetes mellitus, overweight, food allergy (melons and squashes) from an unknown date and unknown if ongoing. Concomitant medications included metformin (METFORMIN) and lisinopril (LISINOPRIL) taken for an unspecified indication, start and stop date were not reported received other medications in two weeks. The patient previously took codeine (Codeine and other narcotics used during surgery) and experienced drug hypersensitivity. The patient was not pregnant at the time of vaccination. No other vaccine in four weeks. No COVID prior vaccination. Facility type vaccine at Public Health Clinic/ Administration facility. On 24Feb2021 at 15:45, the patient experienced tightness in face and neck, throat, throat clearing- like something caught in throat and hoarseness. Adverse event resulted in Doctor or other health care professional office/clinic visit. No treatment received. The outcome of the events were unknown.  Follow-up attempts completed. No further information expected.
SINUS CONGESTION AND DRAINAGE, NONPRODUCTIVE COUGH, HOARSENESS.   PATIENT IS GIVEN A PRESCRIPTION FOR METHYLPREDNISOLONE DOSE PAK.
soreness of the arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (soreness of the arm) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (soreness of the arm). At the time of the report, MYALGIA (soreness of the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant treatment was provided.  No treatment medication was provided.   This case was linked to MOD-2021-279611 (Patient Link).
Initial information received on 04-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA277809 (same reporter). This case involves a 32 months old male patient who experienced received 0.5 ml dose of vaccine FLUZONE QUADRIVALENT (lot UI975AA, expiration date 30-Jun-2019) once via unknown route in the left deltoid instead of indicated 0.25 ml dose on 03 Oct 2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant vaccines given. It was a case of actual medication error due to overdose. It was not reported if the patient experienced any adverse event. 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.
Monday evening 11/10/03. Influenza and Pneumo 23 was given around 1700 shots were given. 1730 noted dizziness at home. 2000 went to bed-both arms sore, left worse than right. Absolute fatigue, headache, sinus feeling pressure. Took Tylenol/ Ibuprofen, tried another medication for relief. Had a rough nite, up six times to get relief of pain, aches in knees in the nite. Tuesday 11/12/03. Kind of lifted. Left arm still sore, shoulder joint to knuckles stiff couldn't use it, muscles felt sore and site hot. Right arm minimal soreness. Felt miserable, no appetite. Sinus headache went to a migraine in the afternoon. 6pm went to be shivering under 3 quilts, vomited, diarrhea started. Taking a lot of Ibuprofen. Wednesday 11/13/03. Headache gone. Couldn't bend elbow today. Slept in the afternoon and went to work, was a little better that she could go to work. Got real hot couldn't drive. Felt like "I had run a marathon." Went to the doctor for another reason, doctor noted fast heart rate. Thursday 11/14/03. Morning arm now bends. Stomach upset, not wanting to eat. Sinus headache, more diarrhea and noted stools dark. Nosebleed and dizziness at intervals. pt called our agency at this time. Pt was encouraged to seek medical evaluation and report the above. She refused. Friday 11/15/03. No breakfast, no appetite, nervous stomach, denies headache and migraine, can move fingers, knee aches and elbow aches gone. 11/20/03 shoulder to elbow stiff. 11/30/03 stiff and aches.
Hives/ welts on legs, butt, arms, hands, ankles and feet, neck and cheeks.  Very intense itching.
ACT HIB was given with Sterile diluent instead of the Saline diluent the HIB comes with. Contacted Sanofi Pasteur and spoke to a nurses in the medical management team. She informed me the vaccine is not valid since it was not given with the correct diluent. Child will have to get another HIB vaccine and there is no wait time. Can be given at any time.
7 days after receiving the shot I developed a rash and itching at the site. It is 13 hours after the rash appeared it is still there and is now around 2 inches by 3 inches.  It itches. I don't think this is an emergency i am reporting it because I think it is unusual and want to know if I should be concerned. I don't know whom to ask.  Also, can I still get a second shot at the same site?
PATIENT BROUGHT IN COVID VACCINATION CARD WITH A FIRST DOSE OF MODERNA FROM 6/4/21 RECEIVED FROM ANOTHER SITE. I GAVE THE PATIENT HIS SECOND DOSE OF MODERNA AND WHEN I WENT TO PROCESS THE VACCINE OUR SYSTEM ALERTED ME THAT HE HAD ALREADY RECIEVED 2 DOSES OF PFIZER FROM ANOTHER  PHARMACY. UPON FURTHER INVESTIGATION IN THE IMMUNIZATION REGISTRY, I SAW HE HAS RECIEVED BOTH PFIZER DOSES AND NOW BOTH MODERNA DOSES. PATIENT DID NOT DISCLOSE THIS INFORMATION AT TIME OF VACCINATION.
This spontaneous report was received from a registered nurse referring to unspecified number of patients of unknown ages and genders. There were not concurrent conditions and medical history reported. On an unknown date, the patients were vaccinated with unspecified and improperly stored doses of VARIVAX (Merck) lot numbers L025210, L017998, L020002, L026406, L034368 and expiration dates 07-JUL-2017, 19-MAY-2017, 02-JUN-2017, 15-JUL-2017 and 08-SEP-2017 respectively (route, dose, dose number and anatomical place of vaccination were not provided). No adverse effects were reported. Temperature/ time frame: 30-JAN-2016 -14 degrees C for 4 hours; 01-FEB-2016 -14 degrees C for 44 hours and -12 degrees C for 9 hours; 02-FEB-2016 -11 degrees C for 15 hours; -10 degrees C for 9 hours; 03-FEB-2016 -9 degrees C for 15 hours and -8 degrees C for 9 hours; 04-FEB-2016 -7 degrees C for 15 hours and -6 degrees C for 9 hours; 05-FEB-2016 -5 degrees C for 15 hours and -4 degrees C for 9 hours; 08-FEB-2016 -3 degrees C for 63 hours. Cumulative -10 degrees C to -14 degrees C for 81 hours (unlimited range) and cumulative -9 degrees C for 135 hours. No previous temperature excursion. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
I had a headache on 3/10 throwing up 3/11 muscle pain, chills, joint pain, fever, trouble breathing, weakness, sore throat, runny nose, left side of throat felt swollen. on 3/12 I felt like the inside of my body arms legs etc all hurt. Tylenol and Hydrocodone didn't help and i was drinking lots of water but vomiting and not peeing a lot. I took meds for my nose and throat but it didn't help. I have weakness still and chills come and go.
muscle aches at injection site muscle aches upper back/shoulders About 18 hours after injection 101 degree fever for approximately 4 hours General weakness/lack of energy but not extensive enough to actually hinder basic activities
had several small pulmonary embolisms in lungs; blood clots in lungs; severely anemic (hemoglobin of 5%); flu-like side effects; muscle tension through neck; fever; fatigue; increased resting heart rate; immune system went into overdrive; shortness of breath; chills; This is a spontaneous report from a non-contactable consumer (patient). A 31-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EW0180) via an unspecified route of administration into left arm on 01Jun2021 17:00 (at the age of 31-year-old) as dose 2, single for COVID-19 immunisation. Medical history included ulcerative proctitis, ulcerative colitis from 2016 and iron deficiency anaemia. Patient was not pregnant. Concomitant medications included minocycline (MINOCYCLINE) and sertraline hydrochloride (SERTRALINE HYDROCHLORIDE). Historical vaccine includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EW0182) via an unspecified route of administration into left arm on 11May2021 at 05:00 PM (at the age of 31-year-old) for COVID-19 immunization and experienced no adverse effect. On 02Jun2021 patient had several small pulmonary embolisms in lungs, blood clots in lungs, was severely anemic (hemoglobin of 5%), had flu-like side effects, muscle tension through neck, fever, fatigue, increased resting heart rate, immune system went into overdrive, shortness of breath and chills. The events resulted in emergency room visit. The events were reported as serious, hospitalization for 7 days and patient was treated with blood transfusions as well as intravenous and oral blood thinners. The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative on 26Jun2021 and negative on 31Jul2021. Outcome of events was recovered with sequelae on Jun2021.  No follow-up attempts are possible. No further information is expected.
Left arm pain and muscle weakness. Started on September 26, 2016 and persisted until current date. Slight swelling in the left deltoid. Pain when lifting things or moving arm too far forwards or backwards. Simple tasks such as putting on a jacket or buckling a seatbelt were very painful. At time it was hard or impossible to lift bags or anything heavier than a few pounds. Went to doctor initially on 12/19/2016 and was given prednisone 10mg 6 day taper as well as baclofen. Returned to doctor on 12/30/2016 due to no progress after stopping prednisone. Prednisone helped while on it but the last few days of the taper pack the pain returned. On 12/30/2016 x-rays were done but came up negative. Tramadol was prescribed but did not help with pain, was referred to an orthopedist at this time. An appointment was made for January with the orthopedist but a snow day caused offices to close and appointments to be rescheduled. An appointment was made for May 11th at clinic with Dr. A cortisone shot was given as well as physical therapy exercises. The cortisone shot helped a little bit but pain continued on. Asked Pharmacy how to proceed and was referred to the CDC.
On Wednesday, 9/1/04: Early morning. She had (small bumpy) bid red splotches all over her body. Took her to school NOB. They said it looked like reaction from the vaccine. Splotches went away and as they went, she had and has single bumps over her body that itch. Still has bumps as of today. September 13, 2004. Still has bumps.