chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chills with severe shaking; Fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills with severe shaking) and PYREXIA (Fever) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ATORVASTATIN, CLOPIDOGREL, HYDROCHLOROTHIAZIDE, LISINOPRIL, Metoprolol Succinate ER and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 30-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced CHILLS (Chills with severe shaking) and PYREXIA (Fever). At the time of the report, CHILLS (Chills with severe shaking) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2021, Pyrexia: 100.1 fever of 100.1F.         The patient's medical history was not provided.  The patient did not receive any treatment. The patient received both scheduled doses of mRNA-1273 prior to the events, therefore, the action taken with the drug in response to the events was not applicable.
while mom was holding baby, pt had a brief loss of breath & gasping turned purple & eyes rolled up;pt began breathing spontaneously;no fever, shaking or vomiting;no CPR given;
Delayed injection site reaction. Redness at injection site, warm to touch, inflamed. Applied cold compress and took ibuprofen.
On 2/15/2000, the pt developed a rash with approximately 7 or 8 lesions. She was afebrile. The pt sought unspecified medical attention. No further information is available. Follow up states patient recovered 02/20/2000. No further information is expected.
High fever; This case was reported by a other health professional via sales rep and described the occurrence of fever in a 12-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number H47PB, expiry date unknown) for prophylaxis.   On 13th September 2019, the patient received the 1st dose of Fluarix Quadrivalent 2019-2020 season. On an unknown date, less than 3 weeks after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The reporter reported that, the patient patient had high fever of 104 degree F after vaccination with dose of Fluarix Quadrivalent 2019-2020 season. The reporter consent to follow up. This case has been linked with case US2019AMR178819, reported by same reporter.
PT RECIEVED VACCINE UNDER RECCOMENDED AGE AT AGE 17, NO OTHER ADVERSE EVENTS AT THE TIME.
pt brought to ED from dialysis center after increasing SOB; dialysis had not been started yet; tachycardia; given O2 supplement; pt had a positive COVID test; pt developed CP and dyspnea; taken to cath lab and determined to have a distal embolus in distal LAD near apex of the heart; pt experienced cardiopulmonary arrest multiple times the day before and the day of her death; after multiple episodes, resuscitative measures were stopped and pt passed away in the hospital
Immunizations given on 12/6/00 at 4 month check-up. Pt had a screaming episode that evening that lasted 3 hours.
About 1 week after vaccination. I had pain in my legs and swelling in my feet, it made it difficult to walk. It was like I was carrying around a dead leg. I did have blood clots in leg. I ended up up being hospitalized 3 days to receive blood transfusions due to anemia after taking blood thinners.
Possible seizure after vaccines. Referred to neurology. Patient is a 12 month old who presents today for follow up after being seen in the ED last night for BRUE. According to mom, child was with sister in law in the living room and cried out to her that child was not breathing. Sister in law picked him up and ran with him, met mom in the hallway and mom states that the child was blue, stiffened and not breathing. No convulsing was noted. Mom states she took him in and laid him on the floor and he remained stiff and not breathing while the EMS was called. She had no idea how long this event lasted. The EMS responded within 15 minutes and by the time that they got there, child was breathing on his own but he had "glassy eyes" and seemed "out of it" and "confused". This lasted until they got to the ED, and then when he got there, he was behaving normally. ED id no additional testing as he was acting age appropriate and sent him home. He has been fine since and in the office today he is awake, alert and in no distress. He is playful and smiling. He was see in the office three days ago per this provider for well child check and received his 12 month vaccines (MMR, Varicella, Hepatitis A, Prevnar). At that time it was also noted that he had a golf ball sized mass on the right clavicle which mom had noted a week before. Xray of area was normal as was an ultrasound of the area. No past medical history on file.
Information has been received from a pharmacist concerning a 59 year old female with latex allergy and no pertinent medical history, who on 20-MAR-2009 was vaccinated with one dose of ZOSTAVAX (Lot # 663775/1789X), 0.6ml, subcutaneously. The pharmacist reported that the patient experienced an injection site reaction. The patient experienced a circular area of redness of the site of vaccine administration. The area of redness increased in size, became hard and warm to the touch on the following day 22-MAR-2009. It was noted that the area of redness had diminished. Follow-up information received from the pharmacist on 24-MAR-2009 indicated that the patient was seen by her and she still had the 4 inch diameter of faint redness at the injection site. The patient also complained of low grade fever and nausea. The patient's status at the reporting time is unknown. The physician prescribed ALLEGRA and ice pack treatments. Additional information has been requested.
I felt like I couldn't breathe in deeply for 6 days. It was just very uncomfortable to breathe deeply, I did not feel pain.  I initially thought it might be walking pneumonia or pleurisy.
Information has been received from a 25 year old female health professional with no drug reactions/ allergies and a history of 2 pregnancies (1 live birth and one elective abortion) who on 20-JUL-2007 was vaccinated with her first dose of GARDASIL, 0.5mL injection. There was no concomitant medication. On 28-SEP-2007 the patient received her second dose of GARDASIL, 0.5ml injection. On 08-OCT-2007 the patient found out that she was 8 to 9 weeks pregnant after getting the first and second doses of GARDASIL. On 27-NOV-2007 an ultrasound was performed with a normal result, "uncertain EDD", estimated to be 31-MAy-2008. Estimated conception date was 24-Aug-2007. The patient sought medical attention. Follow-up information reported that the patient had 2 previous pregnancies. One of those ended in a full term delivery, the other in a miscarriage 8 weeks from LMP. Follow-up information was received. The father of the baby was a cousin with congenital heart problems. On an unspecified date the patient had a urinary tract infection and was given MACROBID. On 27-NOV-2007 and 17-DEC-2007 the patient had a maternal serum alpha-fetoprotein test performed and the results were negative. The reason for the test was the baby's half-brother has downs syndrome. On 28-MAY-2008 a 9 pound 5 ounce baby boy was born. The length was 20 inches and 39 and 4/7 weeks from LMP. The baby's head circumference was 14 inches. The baby was large for the dates and in respiratory distress secondary to pulmonary edema and right pneumothorax. Upon internal review respiratory distress, pulmonary oedema and pneumothorax was considered to be an other medical event. Additional information has been requested.
Broke out in hives on arms and hands. Hives on hand turned into painful nodules.  Joint pain in shoulders and hips. Low grade fever.
24 hours after receiving vaccination patient complain of nausea, dizziness, shortness of breath, and fainting spells
Patient was administered an expired booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired booster dose) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired booster dose). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was reported.
Fever to 101.4, rigors/ chills. Nausea and vomiting. Swollen axillary lymph nodes, body aches and headache.
A physician has reported that a 15 month old male received hi fourth dose of Hib-Titer Vaccine on 8/28/99. That day, he developed a 2-2.5 cm area around the injection site characterized by urticaria and a rash. On 9/29/00, the injection site was more swollen. The physician prescribed Benadryl and the symptoms abated. Follow-up information received form the physician on 11/22/99, indicated that the infant had recovered.
Pt recvd vax 24AUG92 & had fever of 39.5 ax & vomited several times; 26AUG parents reported that pt collapsed twice & was briefly unresponsive-not thought to be sz; MD dx hypotonia; also on 26AUG had fever & vomited; rx w/APAP; recovered;
Lung congestion, shortness of breath, continual coughing up fluid for 2-3 hrs, followed by chills, muscle aches, headache, slept 15 hrs straight.  Completely well after awakening.
8 days after receiving vaccine, pt developed delayed urticarial reaction - evanescent pruritic exanthem on arms and legs and mild angioedema (welts) back of legs.
On February 13, 2021 was a Saturday. I never left my house that day. By early afternoon I felt completely fine but  I started having heartburn and it was bugging me alot. I took a prilosec. I continued my day. As the heartburn still wasnt going away about 8:30 PM I took a chewable tums. I again  I was going about my   business.   At about 12:30 AM now its 2/14/21  i was going to go to bed heartburn was still there so I drank some milk.  I went to bed, I feel asleep and 1 1/2 hours later I woke up feeling as somethings wrong I had a weird allergy type feeling  .Its hard to explain as I grabbed my phone and headed downstairs to take a benadryl. My husband was sleeping.  Within minutes I couldnt breathe at all. I couldnt get upstairs to my husband. I had to call 911. The EMS came and rushed me to medical center.  They let me know my pulse OX was 85% and BP was 200/160.  I only had minutes. This was extreme and I have never been so scared in my entire life.
Ipsilateral axillary lymphadenopathy - mild pain/tenderness at rest, painful with movement of arm; tender to touch
CDC Reports: 5 mo infant receivd DTP/OPV on 23JAN90 and died 24JAN90.
acute onset of cough, chest tightness and shortness of breath starting 3 hours after vaccination. Presented to urgent care facility. Took albuterol every 4 hours which improved symptoms. Developed body aches, nasal congestion in the following days.
pt recv vax 3SEP98 & approx 9AM on 3SEP98 2PM same day pt devel hives gen;seen in MD office on 3SEP98 @ 5PM;pt examined gen hives noted;pt active & alert;rx for atarax;
Woke up because of itching in groin area, stomach.  Took 1 Benadryl and was able to go back to sleep.  On getting up at 6am, wrists were itching as well, bumps under my watch which I removed. Took 1 Benadryl.  Red blotches developed under my arms, across my belly and around my sides, into the crease of my thighs and on my thighs, with small bumps.   Throat was tight. Fingers visibly swelling. Video call with Dr. resulted in Rx 40 MG Prednisone 1/day for 4 days.  Increased Symbicort to 2 puffs/2x day, and told to swallow air. Zyrtec 2x day. Benadryl 1-2 every 4 hours.  Took 1 20mg Prednisone  at 5p in hopes of sleeping, rest as prescribed. Saturday took all meds at 6am.  Had blotches, itching, but reduced within 2 hours.  Took 1 Benadryl only, but increased to 2 T 1p because blotches and rash on belly were returning.  Took evening meds at 6 p, and, 1 Prednisone 20mg at 11 because again blotching and rash including near knees.  Sunday was up at 3a because of Prednisone, no itching.  Took meds at 7a, new bumps and blotching on wrists.  Taking Benadryl 2 tabs every 4 hours.
This spontaneous prospective pregnancy report was received from a nurse and refers to a female patient of unknown age. No information regarding patient's concurrent conditions, medical history and concomitant therapies were reported. On 06-MAR-2017, the patient did urine pregnancy test which gave negative result. On 10-MAR-2017, the patient was vaccinated with a dose of VARIVAX 0.5ml subcutaneously, lot # M040139, expiration date: 28-SEP-2018. On 14-MAR-2017, the patient had a positive home urine pregnancy test. On 15-MAR-2017, the patient had a quantitative serum Human Chorionic Gonadotropin (hCG) test performed and it was positive. The last menstrual period (LMP) date and estimated due date (EDD) were unknown. The pregnancy outcome was pending. No adverse effects were reported. Additional information has been requested.
Headache, UrticariaPruritus & NauseaVomiting Narrative:
Had staff member who went to get primary series vaccine and received bivalent instead; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Had staff member who went to get primary series vaccine and received bivalent instead) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Had staff member who went to get primary series vaccine and received bivalent instead) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Had staff member who went to get primary series vaccine and received bivalent instead) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Had staff member who went to get primary series vaccine and received bivalent instead).    No concomitant medications were reported. It was reported that the patient which went to get the Primary series vaccine but received Bivalent dose instead. No treatment details were reported.
Patient reported extreme swelling and redness in the days after the vaccine, for which she was seen at her primary care physician's office.  She received no treatment; the physician referred her back to the pharmacy to report the adverse event.
Pt. given vaccines on 8/24/2009; came down with rash 2 days later just on upper thighs where shots given- non vesicular, pinpoint, papules, itchy
This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. No medical history or concurrent conditions were reported. Since 18-NOV-2015, an unknown number of patients were vaccinated with RECOMBIVAX (lot # L016427, exp date 13-APR-2017) (concentration, frequency and dosage were not reported) which were exposed to temperatures outside of the recommended range. No adverse experiences were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Initial report received on 18 November 2009 from a health care professional. A 55 year old female patient with a history of high blood pressure and cholesterol developed a soreness of the left deltoid one day after she received FLUZONE (lot number U3212AA) intramuscularly in the left deltoid on 06 October 2009. The patient was seen by a physician who indicated it may be a hematoma. The physician prescribed Ibuprofen and an anti-inflammatory. The patient was instructed to follow up if the symptoms did not improve. The patient was not recovered at the time of the report. Additional information received on 28 December 2009. The previously reported concomitant medication of "cholesterol med" was identified as Simvastatin. No other anti-inflammatory was prescribed in addition to Ibuprofen. It was not reported if the patient had recovered. List of Documents held by Sender: none.
When administering the vaccine with a a 1ml 25G  syringe, the needle was inserted into the arm, but the syringe would not depress. No vaccine could be administered.  The needle was removed. A newly prepared syringe was then used to administer a full dose of vaccine to the patient.
This spontaneous report as received from a Registered Nurse refers to unspecified number of patients of unknown age and gender. On 08-SEP-2014 unspecified number of patients were vaccinated with PNEUMOVAX23 (dose, route, lot # not reported) that had been improperly stored. No adverse event symptoms were reported. This is one of several reports from the same reporter. Additional information is not expected as the reporter did not give a consent for contact.
had a reaction; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (had a reaction) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     NO medical history information was reported.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 1. On an unknown date, the patient experienced ADVERSE DRUG REACTION (had a reaction). At the time of the report, ADVERSE DRUG REACTION (had a reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  No treatment details were reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Jan-2021 and was forwarded to Moderna on 23-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (had a reaction) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     NO medical history information was reported.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 1. On an unknown date, the patient experienced ADVERSE DRUG REACTION (had a reaction). At the time of the report, ADVERSE DRUG REACTION (had a reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  No treatment details were reported.
On 3/29/21, patient went to hospital with chest pain and low heart rate.  Upon arrival, blood pressure was 210/102?.  Was admitted for 5 days.  During stay, scan showed a small Pulmonary Embolism.
On 02/26/05, patient experienced a stuffy nose, congestion but no fever. Given Tylenol. Symptoms continued and she stayed home from work. Saw physician on 03/01/05, who gave her a script for Pannaz and Robitussin AC (not filled yet).
Patient received 2 vaccinations on 7/7/18, SHINGRIX and PNEUMOVAX 23. Pt returned to pharmacy on 7/11 and stated that she has been having muscle spasms since receiving the 2 vaccinations. Stated that she had already had a pneumonia vaccination in the past and was concerned that the shingles vaccination was the cause. Patient stated that she had back surgery several years ago and said that the spasms originated at the site of her surgery and extended towards her abdomen which in turn felt like it was squeezing her lungs making it difficult to breathe. Patient stated that at injection sites there was no reaction or spasms. Patient stated however that the spasms started in the evening after receiving the immunizations earlier in the day. Advised patient that back/muscle spasms were not listed as side effects in either vaccinations list of side effects unless the spasm occurs at the site of injection. Advised patient that if they chose to do so, they should contact their PCP or go to an urgent care clinic for further evaluation if the symptoms continue as it may not be related to immunizations at all but may be a condition that has coincidentally begun. Because patient reported that she was having a difficult time breathing, she should seek medical attention if breathing difficulty continues. Advised patient that report would be made to vaccine adverse reaction reporting site (VAERS) in order to provide documentation to the manufacturer and the CDC if similar side effects have an increase in occurrences. NOTE: Patient able to ambulate and speak clearly at the time she revisited the pharmacy. No visible signs of distress at the time of vaccination or when she returned 4 days later to report side effect.
Pt was in observation after her COVID administration.  She began to feel lightheaded, felt her heart was racing.  She denied SOB, sensation of throat swelling, sense of impending doom.  She reported she had not eaten for hours and felt "very hungry."  She was offered juice but she states she does not drink juice.  She was sipping water.  She ate some crackers.  Feet were elevated upon encountering pt.  She was with her partner.   Initial vitals:  Pulse 58  O2 sat 100%  BP 80/52  (pt reports her BP always "runs low")   5:35 pm vitals:  Pulse 55  O2 sat 100%   BP 96/70.  Pt reports she is at baseline.  Continued to report she felt she had worked herself up into an "anxiety attack."     Pt left facility with her partner eager to "go eat."  She had all contact information if she has any other sxs.  Pt was in observation after her COVID administration.  She began to feel lightheaded, felt her heart was racing.  She denied SOB, sensation of throat swelling, sense of impending doom.  She reported she had not eaten for hours and felt "very hungry."  She was offered juice but she states she does not drink juice.  She was sipping water.  She ate some crackers.  Feet were elevated upon encountering pt.  She was with her partner.   Initial vitals:  Pulse 58  O2 sat 100%  BP 80/52  (pt reports her BP always "runs low")   5:35 pm vitals:  Pulse 55  O2 sat 100%   BP 96/70.  Pt reports she is at baseline.  Continued to report she felt she had worked herself up into an "anxiety attack."     Pt left facility with her partner eager to "go eat."  She had all contact information if she has any other sxs.
Reddened area - spread around to inside thigh by next day. Red and hot to touch. 5 inch x 5 inch