chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Doses administered after 30-day use by date; The vial was initially stored in the refrigerator on 17-Dec-2021 and was administered on 21-Feb-2021; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 17-Dec-2021 and was administered on 21-Feb-2021) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Feb-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 17-Dec-2021 and was administered on 21-Feb-2021). On 21-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 17-Dec-2021 and was administered on 21-Feb-2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The vial had not undergone any temperature excursions and Vaccine beyond use date was 16-Jan-2022. The vial was initially stored in the refrigerator on 17-Dec-2021. No treatment medications were reported.
Immed. after receiving injection client eyes rolled and tongue protruded (siezure like activity)became VERY pale and fainted.  Skin was cold and clammy.  Took several minutes for her to come around.  Client had 2 injection prior to getting the HPV.
Patient called today, June 3, stating last night she experienced itching on the arm in which she received the vaccination.  She also states the area is red. I informed her she could apply ice to the area to  help with itching and told her the redness should resolve in about a week.
Patient was given the Janssen Ad26.CoV2.S vaccine on 8/2/22. Per Pl this SAE is not related. 41 y.o. male with a complex past medical history significant for renal transplant 2022 (ESRD 2/2 obstructive uropathy from neurogenic bladder and horseshoe kidney), HTN, HLD, spina bifida with paraplegia and VP shunt on-situ, Chiari 2 malformation, neurogenic bladder (self-caths every 4-6 hours), neurogenic bowel s/p MACE stoma, recurrent UTIs, recurrent SBOs, chronic migraine, anemia of CKS and iron deficiency, h/o elevated LFTs, mild neurocognitive disorder, OSA on cpap.  Patient presented to the emergency department at clinic on 8/16/2022 with complaints of new onset abdominal pain, nausea and vomiting.  On presentation in the ED (admitted 16:03) her was afebrile, tachycardic up to 103, hypertensive to 166/111. Labs significant for WBC 10, lactate 1.3, normal creatinine. UA shows large leukocyte esterase with moderate squamous epithelials, moderate bacteria, positive nitrites and 51-100 WBC. CT abdomen and pelvis with contrast shows a large small-bowel obstruction in the left lower quadrant with transition point secondary to adhesions in the left anterior abdominal wall and left ileal neobladder.  The patient received antiemetic, pain medication and 1 L NS in the ED. Hospital internal medicine was asked to admit this patient for further evaluation and management.  Patient was placed on bowel rest, with antiemetics and IV fluids. On hospital admit 1 he had a large liquid bowel movement. He did have 1 bout of emesis but reported subjective improvement in his nausea. His symptoms continued to improve throughout the day and his diet was advanced to clear liquids. On 08/19, he was able to tolerate a soft low-fiber diet from a full liquid diet. He was without any fever, chills, chest pain or shortness of breath. His abdominal pain had improved greatly, and he was without any nausea or vomiting.   We obtained a repeat KUB which revealed moderately dilated loops of small bowel, partial small-bowel obstruction.   Urine culture resulted with Klebsiella pneumonia. Pt is chronically colonized. He received 2 doses of ciprofloxacin. Ultimately, given normal WBC and appearing well clinically, along with being afebrile-antibiotics were discontinued.  Renal transplant was consulted for recommendations. They recommended holding off on any treatment for asymptomatic bacteriuria. Additionally, they recommended continuing home dose immunosuppression medications.  Pt discharged on 8/19 at 14:29.
This spontaneous report as received from a consumer refers to a male patient of unknown age. On 04-NOV-2012 the patient was vaccinated with a dose of ZOSTAVAX (lot # not reported) dose and route not reported. No concomitant medications were reported. The reported stated that on 06-NOV-2012 her husband (patient) noticed his arm felt tight. He had redness, swelling and warmth to touch at the injection site. The patient's wife stated that he spoke with the doctor and was told to take CLARITIN by mouth and use BENADRYL cream and ice packs to relieve the symptoms. Outcome of the reported events were unknown. Additional information is not expected.
Pt noted some dizziness after receiving vaccines on 7/24/19 (this occurred while in office, but subsided prior to leaving the office). After arriving home, noted generalized aching, fatigue, and chills. With a dose of Ibuprofen, this improved. Woke up in the morning of 7/25/19 and was sweating and temp was 100 oral. Right arm (injection site for Men B) was sore with movement, but denies any further local symptoms. She had a headache on 7/24/19, but not beyond that date.
Patient experienced lip swelling, tachycardia and flushing after vaccine administration. Patient was evaluated and treated in the ER and has been discharged at this time.
I felt very lethargic, congested, I had a cough, my oxygen saturation was low, felt like I had the flu, I had a low-grade fever of 101F. I went to a local urgent care to find out if I had COVID-19, the flu or what was going on. I was tested for COVID-19, Influenza A and B both tests came back negative. I was diagnosed with an upper respiratory infection and a sinus infection. I was given AUGMENTIN for the sinus infection. I was miserable for four days then started to feel better.
This spontaneous report was received from a pharmacist, referring to a 78 year old female patient. The patient had allergies or reactions to DARVON and tetracycline. On 11-OCT-2017, the patient was vaccinated with PNEUMOVAX 23 for prophylaxis ("one shot", route of administration was not reported; lot # N023651, expiration date 20-MAY-2019). On 12-OCT-2017, the patient experienced an adverse reaction with PNEUMOVAX 23. She developed peripheral edema on the back side of the left arm. The patient also had redness, swelling, and the area was red and hot to the touch. The patient did not seek medical attention and did not receive treatment for the events. No product quality complaint was filed. At the time of the report, the patient had not recovered from the events. The reporter considered the adverse reaction to be related to therapy with PNEUMOVAX 23, while the causal relationship of the other events was not reported.
0952 patient feels lightheaded and would like her BP checked. States she can ambulate, husband assisted to move from general observation area to private obs. Gait steady. BP 114/79; HR 89; O2 98% on room air. States she has multiple health issues in the last year and is carrying her EPI pen for bee sting allergies. EMT on site in attendance 1006 Patient drank 8 oz water total. States she feels better. Is talking a lot. BP 125/88; HR 86; O2 99% on r/a 1008 BP 117/81. States lightheadedness improved.  1010 Stood and assessed. Denies dizziness, offered w/c to personal vehicle. Patient declined. Ambulated with husband to personal vehicle, gait steady. Husband driving. Instructed patient to seek medical attention if symptoms return.
I have had muscle pain in my legs for over a month. About a week after I got the shot I thought I had pulled a muscle from mowing.But it is well over a month and the pain is still there. In the first week it started around the groin area, I could not take full steps, I could not pull my legs up without severe pain. I have had to sleep in the recliner because it was too hard to roll over with my legs. It is very hard to sit and get back up because of the pain in my legs.I do not know if my problems are from the shot, but I Have always been a very active person, The last couple of days my legs have actually felt better, still a little pain, but not like before.
Left thigh redness, swelling and pain increasing over 2 days, fever, treated with antibiotics for possible cellulitis.
The left side of my face beside my nose started itching on Friday Morning around 2:30 am and I had lesions by the time I was able to be a walk-in patient at doctor office on Tuesday, September 7, 2021. (Closed Monday Labor Day). Dr. diagnose me with shingles and prescribed  Valacyclovir HCL to be taken 3 times a d day for 14 days. My second dose was to be on 9/9/21, but was not done due to full blown shingles on the left side of my face, lips, and hairline..  On September 16, 2021, I was given the second dose. On Saturday morning, 9/18/21, my gums on the left side of my face started aching with a stabbing pain like a tooth ache. After contacting. my local dentist to find that the office was closed and five other local dentist, I found another dentist that would see me at 1:30 Monday Morning. 9/20.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 44-year-old female patient who received TWINRIX (batch number 53AT5, expiry date 28th November 2020) for prophylaxis. Concurrent medical conditions included nickel sensitivity. On 23rd May 2018, the patient received the 1st dose of TWINRIX. On an unknown date, less than a year after receiving TWINRIX, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was unknown. The reporter considered the injection site rash to be possibly related to TWINRIX. Additional details were provided as follows: The patient received TWINRIX on an unknown arm. The healthcare professional reported that, the patient broke out in a rash at the injection site. The healthcare professional called to verify if TWINRIX has Nickel in it. No additional information was provided.
This non-serious medically confirmed spontaneous report (initial receipt 18-Sep-2014) concerns female patient. On 16-Sep-2014, the patient received intramuscular AFLURIA (batch number not provided) at 0.5 ml. On 16-Sep-2014 the patient had an allergic reaction to AFLURIA. The outcome was reported as unknown.
Patient developed an occipital rash 3 days after receiving the Zostavax shot. She has had a burning pain over the area and tingling. Treatment - use ice topically, Medrol dose pack, Valtrex 1000mg TID
A report was received from a health care professional on 10/21/2002, concerning a 46 year old female vaccinee who experienced a large welt over the deltoid region of her arm which was described as red, hot and swollen after receiving 0.5ml Fluvirin on 10/15/2002. On 10/15/2002, the vaccinee received 0.5ml Fluvirin intramuscularly. On 10/16/2002 she had developed a large welt described as the size of the vaccinees bicep, which was red, swollen and hot. The vaccinee recovered on 10/18/2002 There was insufficient information to determine the reporters causality assessment. Reference: PJP200200602, PJP200200601, PJP200300598, PJP200200597.
AFTER TETANUS SHOT WAS GIVEN DONOR HAS LOC CONSCIOUSNESS A COUPLE SECONDS AFTER GIVING IT THEN BECAME PALE & SWEATY. HE SID HE INITIALLY FELT LT HEADED & FAINT IMMEDIATELY THEN HAD LOC.
Reports his covid sxs were mild but progressing/States he had pfizer covid vaccine(primary) and the booster which is probably why his sxs were only mild; Reports his covid sxs were mild but progressing/States he had pfizer covid vaccine(primary) and the booster which is probably why his sxs were only mild; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 64 years for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Reports his covid sxs were mild but progressing/States he had pfizer covid vaccine(primary) and the booster which is probably why his sxs were only mild". Therapeutic measures were taken as a result of suspected covid-19, drug ineffective. Clinical course: Caller stated he was prescribed paxlovid for mild COVID 19 infection (omicron variant) and took the first dose yesterday at about 4:15 pm. He developed a 'bad reaction' such as sweating and nausea yesterday. He was unsure whether it was a reaction to the paxlovid or because he took it in close proximity with his other medications. This morning, he took his other medications at around 6:30 am and took the paxlovid at about 9:30 am and has not had any issues since. Asking if there was a recommended time interval between the 2 doses and also the general timing if he was taking other medications. Also suggested that if we were going to update the package insert that it should include the recommended interval between doses. Reported his COVID sxs were mild but progressing (prior to starting product). Stated he had pfizer COVID vaccine (primary) and the booster which was probably why his sxs were only mild.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report as received from a medical assistant, refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients may have been vaccinated with VAQTA (dose, route and lot number were not reported), that were improperly stored (49.3 degrees F. for 2 hours). Concomitant medications were not reported. No adverse effect reported. This case is linked to cases 1404USA005406, 1404USA007012, 1404USA007014 and 1404USA007015 via same reporter link. Additional information has been requested.
Patient felt dizzy starting at midnight. She then said the roof of her mouth became extremely painful (burning pain). Her teeth and gums hurt and she developed a sinus type migraine. She said her lips became swollen and were tingling and painful. Her mouth also became so dry that her tongue would stick to the roof of her mouth.
no adverse effect; improperly stored varivax; This spontaneous report as received from a nurse refers to a patient of unknown demographics. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported.   On 09-SEP-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # R019237 with expiration date: 04-JUL-2020 or lot # S005078 with expiration date: 19-FEB-2021 (strength, dose, route of administration and anatomical location were not reported) for prophylaxis (product storage error). The vaccines were reconstituted with properly stored sterile diluent. The vaccines exposed to a temperature of  -14 degree celsius to -10 degree Celsius (-9.74 degree celsius). There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported.
received an expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th November 2021, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 19th November 2021, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The patient received expired dose of Boostrix vaccine, which led to expired vaccine used. The reporter did not provide more details. The reporter consented to follow up.
Day of Vax:  At about 2pm....I had a severe reaction forcing me to lay down for several hours....body aches and pains, mental confusion, really weird feelings throughout my body. I had to take sick time from work.  I felt better in the evening. Day 2(wed):  woke up with moderate/extreme fatigue....body did not feel good...could not work took more sick time...spent most of day in bed. Day 3(thurs):  Was going to try to get back to regular schedule.....worked in the morning...did my usual lunch time hike.....in the afternoon suffered from another bout of moderate/extreme fatigue...could not work..took more time off....in the evening had chest pain in my back between my shoulder blades. Day 4(fri):  I am filling out this form...woke up with pain in between my shoulder blades....that seems to be feeling a little better now....I am trying to get back to my regular routine and have been working this morning.  I believe that I will continue to get fatigued for a few more days....and I'm very sensitive between my shoulder blades.
Information has been received from a health professional concerning an approximately 30 year old male who was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine (Lot # 647038/0926N). Within 48 hours of vaccination, the pt experienced a site reaction from the should to the elbow including "swollen, red, hot, and tender to touch."  It was reported that the pt was treated with antibiotics for the condition. This was one out of two pt's reported. It was reported that "one of the pt's developed a fever". The other pt (WAES # 0405USA01694) had a similar reaction after vaccination with pneumococcal 23v polysaccharide vaccine (Lot # 647038/0926N). Additional information has been requested.
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Severe, Additional Details: itching, burning sensation, swollen site, very painful. using ibuprofen and tylenol with cold pack
This spontaneous report was received from a healthcare worker and refers to a 11 week old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 23-JUL-2015 and on 24-SEP-2015, the patient was vaccinated with two separate doses of improperly stored ROTATEQ (doses were not provided) lot # K023534, expiration date: 22-MAY-2016 and lot # K016261, expiration date: 23-JUN-2016, orally. No adverse effect were reported. Additional information has been requested.
Moderna COVID-19 Vaccine EUA: very swollen arm, red, soar, hot and itchy. I felt hot for about 3 hours, then sick to my stomach for the day and very tired.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned an 18 year old male. Initial information was processed along with the additional information received on 17-AUG-2021. The patient's height, and weight were not reported. The patient's concurrent conditions included: cigarette smoker, human immunodeficiency virus (HIV) positive, irritable bowel syndrome (IBS), immunocompromised, and non-alcohol user. The patient had no known allergies nor history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808609 expiry: UNKNOWN) dose was not reported, 1 total administered to left deltoid on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 16-AUG-2021, the patient got tested for the antibody and the results came back as undetected or negative (coded as confirmed immunological vaccine failure). The patient was not sure if the vaccine was working or whether he would need a booster. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). The case is associated with Product Quality Complaint number 90000189821.; Sender's Comments: V0:20210832913-COVID-19 VACCINE AD26.COV2.S-Confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Information was received from a certified medical assistant concerning multiple unspecified patients, who on unknown dates, were vaccinated with PEDVAXHIB that were exposed to temperatures outside of recommended condition. No adverse events were reported. No further information was provided. This is one of four reports from the same reporter. Additional information has been requested.
Had some hives emerge on my back within 24 hours of the 1st shot. It was not that bad but I had not expected that as a symptom.; I also had a couple of hours feeling foggy; Tired; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 14Apr2021 at 10:30 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included estradiol (YUVAFEM); for an unknown indication from unknown date and unknown if ongoing. On 15Apr2021 at 17:30, the patient experienced some hives emerged on her back within 24 hours of the first shot. It was not that bad but she had not expected that as a symptom. She also had a couple of hours feeling foggy and tired. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events a couple of hours feeling foggy and tired were recovered on 15Apr2021 and hives emerge on her back within 24 hours of the first shot was recovered on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Pt started with a burning sensation on her are approx 1-3 hours after vaccine given. Pt came in today to have us check her arm.  She received her Flu and Pneumococcal vaccines yesterday.  The site (right deltoid) where the pneumococcal was given is red and hot to touch, it is 1 1/2 x 2 in in diameter.  States it started in the evening. She felt an achy/burning feeling, but later in the evening when showering, she felt a burning sensation when the water would hit.  States it was larger, she's been applying cold packs and it's come down.   Per Dr., pt advised to continue watching and applying the ice packs,  have marked it and have asked her to let us know if it goes beyond the parameters. She's also to let us know if she get a fever for any unknown reason.  Her temp today in office was 98.9.