chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Blood test Abnormal; This spontaneous case was reported by a physician and describes the occurrence of BLOOD TEST ABNORMAL (Blood test Abnormal) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BLOOD TEST ABNORMAL (Blood test Abnormal). At the time of the report, BLOOD TEST ABNORMAL (Blood test Abnormal) outcome was unknown.        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.   RINVOQ used as Suspect drug.  No concomitant medications reported by investigator.  No treatment medications provided by the reporter.   This case was linked to MOD-2021-113630 (Patient Link).
Soreness at injection site; Redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Soreness at injection site) and INJECTION SITE ERYTHEMA (Redness at injection site) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided).   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PAIN (Soreness at injection site) and INJECTION SITE ERYTHEMA (Redness at injection site). At the time of the report, INJECTION SITE PAIN (Soreness at injection site) and INJECTION SITE ERYTHEMA (Redness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information was reported. Treatment information was not reported.
On the eighth day the injection site began to itch, then it turned into a red rash and began to swell and had a fever in it. I drew a circle around it with an ink pen and over the course of the next three days the heat, circumference, and swelling increased and then it went away.
Developed a body rash after my second Moderna vaccine, sore arm, bruise around injection area. Raised red rash around underarms, necks, back and front mid section.  Started taking Benadryl 4/24 and one the morning 4/25.   slightly itchy.
Patient states she developed a warm feeling over injection site traveling to her left neck. She started crying, shivering and shaking uncontrollably in bilateral upper and lower extremities. She had no fever at this time but developed a fever soon after.
Headache, arm pain, sensation of heaviness, itchy in the are of injection, lower arm pain (axial) side pain. After second dose and weeks after I still have pain under axillary and side pain.
W/in 24 hours pt's mom noticed rash. Went to fast care and provider diagn. cellulitis & given prescription for KEFLEX.
Patient developed extreme itching all over her body 2 days after receiving her 1st dose of Shingrix. She also had a headache that has gotten progressively worse. Itching behind the right eye with visible redness of the eye. She contacted her doctor 5 days after receiving shot but has not heard back. She had been using acetaminophen for the headache and was asking if Benadryl is okay to use for the itching. Recommended using Benadryl + famotidine until she can speak with the doctor.
From initial information received on 19Jan05 from a physician regarding an adverse event occurring, it was reported that a 32 yr old female pt received a dose of Tet tox Ads USP lot U1367AA, admin IM in the left deltoid on 14Jan05. Two to three minutes later, the pt developed numbness and tingling in her left hand. One hour later, she also developed left shoulder pain. The pt was treated with oral Benadryl and the symptoms resolved after five hours. The symptoms were considered to be a possible vasovagal episode as per the reporter. The pt recovered from these events. From additional information received on 14Mar05 from the responsible physician, it was reported that the pt's vasovagal symptoms were not known. At the time of this report, the pt has completely recovered from these events. No further information is anticipated, this case is considered closed.
6 days post vax, pt phoned stating right deltoid area red, hot, swollen the size of a softball, but has gone down considerably. Saw PCP. Pt stated PCP thought it was an allergic reaction and treated with Keflex in case this was an infection.
This case was reported by a nurse via sales rep and described the occurrence of cellulitis in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced cellulitis (serious criteria GSK medically significant). On an unknown date, the outcome of the cellulitis was unknown. The reporter considered the cellulitis to be related to SHINGRIX. Additional details were provided as follows: The patient's initials, gender, or date of birth were unknown. The age at vaccination was not reported. The patient received SHINGRIX in an unknown deltoid and experienced cellulitis below the injection site for longer than five days. This was all information provided by the reporter and the field representative had very limited information.
With the first shot, I sat in the recliner for 4 hours and slept because I was so tired as soon as I made it home. When I woke to go upstairs to my room, I could not make it, had to sit on the steps due to shortness of breath and heart palpitation. Once I caught my breath I continued up but had to hurry and find a seat due to shortness of breath. I already had an appointment with my Dr.s office so I went ahead and kept the appointment.   I had to drive and always would drive myself but on this occasion I was not able to and my children could not get off to take me so my granddaughter and great granddaughter went with me. I usually drive myself but was unable to stay awake for the drive so she drove me.   After the second shot, my entire body was swollen from my head to mt toes. I could not wear any of my clothes, shoes, or underwear. I then made another drs appointment locally this time.  The Dr. took chest x-rays and said it looked like I had an enlarged heart. So he referred me to a cardiologists. He also prescribed me Furosemide until I could see the cardiologist.  The prescribed medicine helped a little with the swelling but not enough.  When I went to the cardiologist, I told him it was the shot, but he just prescribed me a bunch of medicines instead of listening to my concerns. He prescribed me:  potassium cler 10meg 2 daily bumetanide 1 mg 2 daily carvedilol 12.5mg 2 daily entresto 24-26 mg 2 daily  He took me off valsartan and put me on entresto.  I've had two echocardiograms that said my heart was a little weak. I've also had a nuclear stress test that revealed I was normal.
New onset of persistent cough, throat tightening, nausea, felt sick to my stomach, heart rate 100, usually 60, SBP 124, usually in the 90's.  Flushed face, bloodshot eyes, dizziness and weak. I told employee health nurse, same one who administered the vaccine and she took my vitals signs, but didn't readily admit it was a reaction and suggested I was anxious and had caught a cold, and could be from asthma and I repeatedly told her I do not have asthma, nor does anyone in my family.  I was very happy in the morning and had no reason for anxiety.  I also felt perfectly healthy in the morning. The coughing was strong and throat tightness for the first 1-2 hours and I was afraid it would get worse.  Thankfully around 3 pm the coughing lessened, but the dizziness got worse.  I had a reaction to the live H1N1 vaccine in 2009 and had the dizzy symptoms for 5 days, but never before in my life have I had my throat tighten.  I have had strep throat many times and it hurt, but never tightened.  I had one of the doctors examine my throat and he said there was no swelling and heard no wheezing when he listened to my lungs. The next day when I woke up I no longer had symptoms.  I notitifed employee health.
On 3-1-18 pt seen with 13.5 cm x 12 cm wide of redness and mild swelling from bottom of shoulder to just above left elbow, pt started on AUGMENTIN ES-600 600-42.9 mg/5ml give 3.5 ml BID for 10 days. Pt seen for follow up on 3-2-18 with 16.5 cm  x 12.5 cm wide of redness and mild swelling from bottom of shoulder to just above left elbow, non-tender, full strength and ROM, SL warm. SL redness extended from marked line only by less than 1 cm. Slight increase in circumference of arm from yesterday. However looks like more local reaction than cellulitis. However would continue AUGMENTIN. Start BENADRYL - can do Q6H for next 24 hours - 5 mls. Warm compresses. Monitor site. Fever, pain, increase swelling - mom aware to call back.
No additional AEs were reported,; Pharmacy tech called and reported that an expired MMR II vaccine was given to a patient.; This spontaneous report was received from a pharmacy technician referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions/allergies were not reported.  On 27-FEB-2023, the patient was vaccinated with an expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, lot #u006489, expiration date: 26-FEB-2023, therapy type: rHA, administered for prophylaxis (dose, strength and route of administration were not provided) (expired product administered). No additional adverse events (AEs) were reported (no adverse event).
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II lot # L024993, expiration date 17-OCT-2017; lot # L043214, expiration date 30-AUG-2017 (therapy type, dose and route of administration were not reported). Administered doses of vaccine experienced the temperature excursion of 34 degrees Fahrenheit for 3 hours. Data logger was not involved. There was no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Initial solicited report received on 26 October 2016 from an investigator participating in the study. This case involves a 66-year-old female subject who had injection site reaction, rash, fever, itchiness and was very uncomfortable. The subject's medical history and concomitant therapies were not reported. The subject stated that, two years ago she had this specific intramuscular dose of FLUZONE HD and had violent reaction within 24 hours; rash, fever, itchiness and was very uncomfortable (date unspecified) and developed injection site reaction in 2014 (latency unknown). The subject further mentioned that now she had just regular shot and was not allergic to anything and before that and since she did not had any reaction of any sort. Lab data and corrective treatment were not reported. The outcome of injection site reaction, rash, fever, itchiness and very uncomfortable was not reported. Relationship to investigational product according to investigator: not reported. Relationship to investigational product according to Company: associated.
I received my second Pfizer shot on Saturday April 10. On Tuesday April 13 I developed a headache which got worse by the afternoon. I took a nap and when I woke up I still had a headache.  Then I vomited several times.  The next day I was better.
Patient describes a swelling of a lymph node in the armpit area. Patient was advised to bee seen by his regular Doctor's office
2day p/vax broke out w/welts on face only; felt warm;welts were on face 3rd day;no meds given;felt warm 3rd night'-10pm;also welts; up 3:10am had bottle;4:45am found dead; no fever noted 3:10am
On 1/21/22 approximately 6 PM, I noticed my left eye vision was blurry, my tongue was feeling numb and then my left cheek drooping.  I asked my husband to look and then my whole left side of face was drooping.  Within a minute or so, my left arm became limp and progressed down my left thigh and left leg.  I was not able to ambulate. My husband carried me to the car and drove me immediately to the ER.  Immediately was taken back and assessed by doctor (Via tele med) on computer.  A CT with contrast was completed and a recommendation was to start on a ?migraine cocktail?.  IV started and cocktail started.  Then recommendation was for Stat MRI but no MRI facility nearby.  They called multiple hospitals to locate a room (and stat MRI) and the nearest was at Medical Center I was transported via ambulance to (Med Ctr) around midnight/early AM of 1/22/22.  Brought in by stretcher to ER, was given stat MRI and admitted to Neuro Science/Primary Stroke Center at Medical Center.  Multiple tests were run throughout the next 1-2 days including Carotid arteriogram and ECHO cardiograms, IV fluids, medications. By Saturday evening I was able to talk and move both arms and legs. I was eager to leave the hospital and was discharged to home on Sunday 1/23/22. I was told to follow up with my PCP and with Neuro Dr., but no apt was made for me prior to my discharge.
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patients were vaccinated with VARIVAX lot# N012619 with expiration date 21-APR-2019, lot# N012487 with expiration date 20-APR-2019, lot# N014368 with expiration date 09-MAY-2019 and lot# N009766 with expiration date 24-MAR-2019. The vaccine was reconstituted with properly stored sterile diluent. The vaccines underwent a temperature excursion between 15 and 46 degrees Fahrenheit for 2 hours and 13 minutes. Digital data logger was used to record the excursion. No previous temperature excursion was noted. No adverse event was reported. This is one of two reports received from the same source. Sender's Comments: US-009507513-1709USA001955.
administered a Flublok to a 14 year old; Initial information received on 28-Aug-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 14 years old patient who received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA1906 via unknown route.  It was a case of potential medication error due to Inappropriate age at vaccine administration.  It was unknown whether adverse event was experienced or not.  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.
Info has been received from a licensed practical nurse concerning a 63 year old retired female pt with a history of hypertension and no known drug allergies who on 06/17/2002 at approx 10:30 was vaccinated intramuscularly in the right deltoid with a 1st dose of pneumococcal vaccine 23 polyvalent (Lot #641804/0035M). There was no illness at the time of vaccination. Concomitant therapy included hydrochlorothiazide (manufacturer unknown), bisoprolol (+) hydrochlorothiazide (ZIAC), aspirin, thyroid, salmaterol xinafoate (SEREVENT) and calcium carbonate (OS-CAL). Subsequently on 07/17/2002 the pt developed a red, hot to touch, painful 6.5 by 7.5 inch site around the injection site. Unspecified medical attention was sought. Subsequently, the pt recovered. The nurse also reported a 2nd patient that had a similar experience after being vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot #641804/0035M) (WAES #0207USA01694). Additional info is not expected.
Having reactions to the 2nd shot; Throwing up multiple times; Nauseous; Arm was hurting; Slowly started to have spiking fever,fever of 100.9 degrees Fahrenheit; Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm was sore), VACCINATION COMPLICATION (Having reactions to the 2nd shot), VACCINATION SITE PAIN (Arm was hurting), PYREXIA (Slowly started to have spiking fever,fever of 100.9 degrees Fahrenheit) and NAUSEA (Nauseous) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0022M0A and 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included FAMOTIDINE, PAROXETINE HYDROCHLORIDE (PAXIL [PAROXETINE HYDROCHLORIDE]), DEXLANSOPRAZOLE (DEXILANT), LORAZEPAM (ATIVAN) and VITAMINS NOS for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced VACCINATION SITE PAIN (Arm was sore). On 26-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Arm was hurting) and PYREXIA (Slowly started to have spiking fever,fever of 100.9 degrees Fahrenheit). On 27-Mar-2021, the patient experienced NAUSEA (Nauseous). On an unknown date, the patient experienced VACCINATION COMPLICATION (Having reactions to the 2nd shot) and VOMITING (Throwing up multiple times). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) on 26-Mar-2021 for Pyrexia, at a dose of 1 dosage form; PARACETAMOL (TYLENOL) on 26-Mar-2021 for Pyrexia, at a dose of 1 dosage form and ONDANSETRON (ZOFRAN [ONDANSETRON]) on 27-Mar-2021 for Nausea, at a dose of 1 dosage form. At the time of the report, VACCINATION SITE PAIN (Arm was sore), VACCINATION COMPLICATION (Having reactions to the 2nd shot), VACCINATION SITE PAIN (Arm was hurting) and VOMITING (Throwing up multiple times) outcome was unknown and PYREXIA (Slowly started to have spiking fever,fever of 100.9 degrees Fahrenheit) and NAUSEA (Nauseous) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Mar-2021, Body temperature: 100.9 (High) High.         Concomitant medications used by the patient includes Birth Control patch (NOS).   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Added new events.
Information had been received on 24-JUL-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a female patient of unknown age was inoculated (by an unspecified person) with ZOSTAVAX vaccine (dose, route, site of administration, lot # and expiration date were not provided) on or about 03-MAR-2013 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The patient's medical history, concurrent conditions and concomitant medication were not provided. The lawyer reported, the ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused patient to contract a persistent strain of Herpes Zoster. On or about 04-SEP-2015, the female patient was treated at a dermatology and skin surgery center (It was not specified who treated the female patient), for a painful and blistering vesicular outbreak, which was diagnosed as Herpes Zoster, or shingles.  The patient was prescribed Triamcinolone for management of her painful symptoms. As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information has been requested.
Left side face swelling; This is a spontaneous report from a contactable consumer reported for herself. This 56-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6207) via an unspecified route of administration in the left arm (reported as "left shoulder") on 07Apr2021 13:00 as a single dose for covid-19 immunisation. Medical history included asthma diagnosed as a child. The patient stated it's not ongoing, it's more during seasonal allergies. She took Singulair to help. Concomitant medications were unknown. The patient had Pfizer covid19 vaccine on Wednesday 07Apr2021 and left side face swelling yesterday on 08Apr2021. It's on the left side of the face. It started around the eye and currently she can feel it running down the side of the face. Left side face swelling was reported as worsened. The patient asked if she would be okay to get the second vaccine. She stated she was not in pain, but was concerned that she won't be able to get the second vaccine. She had not treated the swelling yet, and was not sure if she should see her doctor. She was scheduled for the second dose of the vaccine. The patient had no prior Vaccinations (within 4 weeks). Outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Information has been received from a pharmacist concerning a 62 year old female with allergic reaction to TETRACYCLINE and PHENOBARBITAL who on 30-JAN-2009 was vaccinated with ZOSTER vaccine live (Oka/Merck) (lot number 662971/1213X) 0.65ml SQ (site not reported).  Concomitant therapy included METHADONE HC1 and DICYCLOMINE HC1.  On 01-FEB-2009 the patient developed a welt at the injection site that is about 3cm in diameter.  On 02-FEB-2009 the injection site was itchy.  The patient's welt at the injection site and itchy persisted.  The patient's adverse events persist.  Additional information was received from the consumer concerning her self.  The patient reported that on 31-JAN-2009 she noticed that that site was painful and warm to the touch and raised (welt about 3 inches in diameter).  Additional information has been requested.
Day after receiving the vaccine, the patient complained of abdominal pain which worsened over the day.  She went to the ED and was hospitalized.  Abdominal pain complaints increased and continued, she decompensated rapidly, was intubated and subsequently died 3 days later.  Imaging results showed, progressive ovarian cancer in the bowels.  Blood culture revealed that she had E.Coli in her blood.  It is thought that this is NOT related to the vaccine.
This is a spontaneous report from a physician who is also the vaccinee. He received dose 2 of Havrix in 03/99. Within one week post vas, he noticed ecchymosis at the injection site, which turned blue, then yellow becoming more prominent, but not uniform, a few days later - with more tendrils than expected from the bruise. The vaccinee had some awareness of discomfort but no pain.
He had soreness at the site, he is extremely tired and fainted upon standing. He additionally has a headache and is clammy/sweaty.
pt explained that for 2 or 3 days after the vaccine administration, she had fever and chills and diarrhea and nausea and dehydration and headache