chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. On 17-OCT-2014 the patient was vaccinated with PROQUAD (Merck) (0.5 ml, subcutaneous, lot # K005195, expiry date: 10-OCT-2015) which underwent a temperature excursion prior to being administered. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Severe constipation; This spontaneous case was reported by an other caregiver and describes the occurrence of CONSTIPATION (Severe constipation) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced CONSTIPATION (Severe constipation). At the time of the report, CONSTIPATION (Severe constipation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. No concomitant medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Event assessment updated from not provided to not related.
PAIN ON THE OPPOSITE ARM/LEG FOOT; This spontaneous report received from a patient concerned a 45 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included thyroid disease, high blood pressure, depression, asthma, sleep apnea, grass allergy, cat allergy, tree allergy, dust allergy, alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no history of drug abuse/illicit drug use. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 22-MAY-2021 for prophylactic vaccination. Concomitant medications included levothyroxine for sleep apnea, amlodipine, and losartan potassium. On 24-MAY-2021, the subject experienced pain on the opposite arm/leg foot. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from pain on the opposite arm/leg foot. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
From June through August 2021 I had on and off all three months bleeding during my menstrual cycle. The cycle went back to normal in September.; I also had rather strong headaches on and off.; Fatigue.; This is a spontaneous report from a contactable reporter (consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in right arm, administration date 07May2021 at 13:00 (Lot number: EW0172) at the age of 52 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "None" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Codeine, reaction: "Drug allergy", notes: Known allergies: Codeine and Zithromax, reaction: "Drug allergy", notes: Known allergies: Zithromax. Vaccination history included: Bnt162b2 (DOSE 1, 0.3 ML SINGLE, Lot Number: EW0169, Anatomical Location: Right arm, Administration time: 13:00), administration date: 16Apr2021, when the patient was 52 years old, for COVID-19 immunisation.  The following information was reported: MENSTRUATION IRREGULAR (non-serious) with onset 01Jun2021, outcome "recovered" (an unknown date in Sep2021), described as "From June through August 2021 I had on and off all three months bleeding during my menstrual cycle. The cycle went back to normal in September"; HEADACHE (non-serious) with onset 01Jun2021, outcome "recovered" (an unknown date in 2021), described as "I also had rather strong headaches on and off"; FATIGUE (non-serious) with onset 01Jun2021, outcome "recovered" (an unknown date in 2021), described as "Fatigue". Therapeutic measures were not taken as a result of menstruation irregular, headache and fatigue.  Additional information: The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient also received Bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Anatomical location: Right arm, Lot Number: FD0809, Administration time: 13:00), administration date: 27Dec2021, when the patient was 53 years old, for COVID-19 immunisation.
Had period early and while I was ovulating. Lasted 2x longer than normal. No cramps though. Lasting brown discharge days after period ended. Been regular like clockwork for past 20 years. This was out of ordinary. Then today, 2 weeks later, got my period again. This was my regularly scheduled period. Not normal.
patient received Moderna bivalent booster doses that had undergone a temperature excursion; patient received Moderna bivalent booster doses that had undergone a temperature excursion; Product storage error; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (patient received Moderna bivalent booster doses that had undergone a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (patient received Moderna bivalent booster doses that had undergone a temperature excursion), PRODUCT STORAGE ERROR (Product storage error) 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)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patient received Moderna bivalent booster doses that had undergone a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (patient received Moderna bivalent booster doses that had undergone a temperature excursion), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (patient received Moderna bivalent booster doses that had undergone a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (patient received Moderna bivalent booster doses that had undergone a temperature excursion), PRODUCT STORAGE ERROR (Product storage error) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (patient received Moderna bivalent booster doses that had undergone a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (patient received Moderna bivalent booster doses that had undergone a temperature excursion) and PRODUCT STORAGE ERROR (Product storage error).    This case is about 7th patient out of 77 patient. Concomitant product use was not provided by the reporter.   No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:Master case
Mild swelling over right cheek/jaw- Parotid gland with mild tenderness. No cervical lymphadenopathy. Afebrile. No swelling nor erythema gums.
Fever 101.9°F, began around 12:00PM Nausea, moderate, began around 9:00AM Resting Tachycardia, 125-145bpm, began around 12:00PM Headache, moderate, began around 9AM Fatigue, severe, began around 9AM  Called virtual doctor, was advised to see an urgent care. Urgent Care confirmed tachycardia and fever, EKG returned sinus tachycardia. Given 1g of acetaminophen and told to rest, take 1g every 4-6 hours.   As of 4:30PM on 4/3, patient still feels feverish and tachycardic. doctor expects patient to make full recovery, but advises emergency department visit if heart rate raises to 150bpm and does not lower.
Approximately 10 minutes after Prevnar, Pediarix, and Influenza preservative free were given hives at neck with pruritis noted. Within 5 minutes swelling of eyelids noted.  No respiratory problems.  MR received from pediatrician which reveals development of facial hives and swelling of the eyes which began approx. 10 minutes following dose #3 of Pediarix and Prevnar, and dose #1 of preservative-free Flu vaccine. No past hx. of vaccine rxn. Initially treated with po Benedryl, but hives continued to spread to the neck and eyelids.  Infant was then treated with SQ epinephrine and po Prelone after which the hives and swelling began to diminish. No anaphylaxis per MD. Infant was sent home with instructions for Benedryl and Prelone usage.  TC from father 24 hours later reported no further hives.  F/U visit to Ped. 2 days post vax. showed infant continuing to do well without further hives. To F/U with allergist. Diagnosis: "Allergic reaction resolved, ? due to egg in Flu vaccine vs. other vaccine preservatives"./
The patient was sitting in a chair on the sidewalk.  He received the Pfizer vaccine lot # EW0172 exp 04/25/2021 in the right arm at 10:40am. At 10:41am the patient said ?my arm feels hot,? as he motioned to his right arm where he received the vaccine. RN checked the patients arm.  There was no sign of rash or redness. At 10:42am the patient stated, ?Now my whole body feels hot.? The patient denied feeling dizzy or nauseous.  Per RN's assessments, patient was not flushed, no rash was present, skin was dry. Skin appeared appropriate color for race. The patient insisted on standing up but reported feeling ?dizzy? and looked unsteady as soon as he stood up. RN assisted the patient to sit back down. The patient was given a mat to lay down on but he refused to lay down or put his head between his legs.  He sat up with his hands in his hands covering his face.  Vitals were taken at 10:45am by RN.  RR 18 and no signs of respiratory distress, BP 130/82, HR 68 with regular rhythm per palpation. Patient was offered Benadryl but he refused and still refused to lay down.  At 10:50am the patient said, ?I feel all better now.?  The patient was advised to stay for the remainder of his 30 minute observation period but he refused and walked off with a steady gait.
On Sunday night I had a bit of sore throat and fatigue. Monday again sore throat and fatigue. Monday night I started to get shivers, fever and cough. Then on Tuesday I had muscle soreness and more significant fever and cough with a heavy chest. Wednesday was the peek infection and I did video call with physician because my temperature was 103.8. My heart rate was 120 resting. My fever decreased during the day. Heart rate decreased day 4. Symptoms began to improve and by Friday just lingering fatigue and heavy cough; no more fever.
04/20/2021 Chronic cough, preexisting, but was not every single day until 2 days after vaccine. Happens every single time I lay down on my side and it is not a wet or productive cough. No new treatment. Doctor diagnosis it a "Long Covid" and should go away on its own. Ongoing to this day.
This is in follow-up to report(s) previously submitted on 6/14/2007. Initial and follow up information has been received from a Licensed Practical Nurse (LPN) concerning a 22 year old female mathematician with a penicillin allergy and no pertinent medical history who was vaccinated with Gardasil on 25-MAY-2007, IM in to left arm with a first dose of GARDASIL lot #657736/0389U. Concomitant therapy included TRIPHASIL. In follow up it was reported that the patient received injection and remained seated for several minutes after injection. On 25-MAY-2007, at 02:00 PM she walked to front desk area to pay co-pay, while standing patient fell over towards left on nurse. The nurse grabbed patient and lowered to ground. The patient fainted five to minutes after receiving her first dose of Gardasil on 25-May-2007. Patient fainted and the nurse used ammonium acetate to revive patient. The patient revived and fully recovered within 15 minutes. No other information was reported. Additional information has been requested. Additional information is not expected.
Patient had his 1 yr well-baby check-up on Friday, January 16, 2009 and everything checked out perfectly for him.  He was given his vaccinations of 2nd dose of Flu, Chicken Pox, and two others that I'm not sure of.  He seemed a little fussy on Friday evening and off and on through the weekend so we did give him tylenol before bed and to help with the soreness at the injection sites.  On Tuesday, January 20, 2009 he was his happy ol' self.  We decided to go out to dinner that evening so I woke patient from his late afternoon nap just before 6 p.m. and he felt warm so we went to dinner thinking we'd have him eat before we gave him any tylenol or motrin and while we were at dinner, he ate and then didn't want to eat anymore, snuggled with me for awhile and then wanted daddy.  While sitting on daddy's lap he fell forward and was completely limp, this happend just before 7 p.m.  His eyes started rolling back in his head and his breathing slowed and he started to seize.  We called 911 and he continued to seize and began to vomit while in the ambulance to the hospital seizing for between 10 and 15 minutes.  Once in the ER he layed on the bed with big tears and little or no noise.  They took his temp and he was 102.2.  After he came out of the seizure we noticed he had no movement in his right arm or leg and that lasted for nearly 2 hours.  The ER did blood work on him, urine tests, a chest x-ray with all coming back normal.  He was admitted overnight and they performed an EEG on him Wednesday morning which also came back normal so his Dr. felt it was most likely caused from the chicken pox vaccine.  We were discharged Wednesday evening around 7:30 p.m. and asked to bring patient in Friday morning at 8 a.m. to be rechecked.  He was rechecked and everything was normal except he continued to run a temp.  His doctor told us that he would probably end up with a rash within the next day or two and then we'd know for sure.  His fever stopped on Saturday evening and a rash began to appear Sunday.  I contacted his doctor this morning to let him know how patient was doing and his nurse asked me to bring patient in to look at the rash.  When his doctor looked him over he said it looked more like rosiolla rash than chicken pox but that he wouldn't recommend and 2nd chicken pox vaccine for patient.  The only medication given to patient while in the hospital and at home to keep his temp down was tylenol and motrin.  His doctor did prescribe Diastat in case he seized again.  The prescription cost $313.00. 3/3/09-records received for DOS 1/20/09-admitted because of febrile seizure that was complicated, received vaccines 5 days prior and was crabby that evening, awoke with temperature of 102 and was fussy and then had a generalized tonic/clonic seizure, continued to arch and have right-sided weakness, stayed ictal for about half an hour then postictally and 3-4 hours before lost Todd's paralysis resolving .Assessment:complicated febrile seizure possibly exacerbated by immunization.
After the second shot, roughly within a 10 minute period I felt my body starting to want to be itchy. I had what looked like little pale goosebumps on my arms and torso area. I Wasn't expecting anything, as after my first vaccination FA7484 lot on 7/30/21, I had minor body aches approximately 6 hours post shot and no other adverse side effects.  After second dose 3 days post shot, Monday 8-23-21 woke up to very itchy forearms, back of hands and slightly swollen fingers.  Both arms have fine light pink rash, and lower legs below knee area. I emailed the Allergist who monitored my first shot and suggested onboarding with Allegra 24 1 hour prior to my shots. I let the doctor know of the rash and that I was taking .50 doses of Benadryl every 6 hours. The rash was warm to touch but today 8-24-21 isn't as warm, but present. Continuing to monitor body area and see if any other areas are itching. Rash very itchy, only darker pink if I scratch, followed with a burning sensation. Notified my GP as well, but out of town. I will continue to monitor. No breathing issues or other problems, except the very itchy inner forearms and sometimes back of forearms. Nothing where shot was given.
Difficulty breathing, fast heartbeat could not eat supper. Severe headache for 3 days. Sinuses would not drain 3 days. Very weak 3 days, (I am a healthy senior).
Extreme vomiting, fever, body aches, chills starting around 4am until 5pm. Body aches continued with fever. I would rather have covid than this
Within 1 h, pain from injection site to neck. Neck pain felt like meningitis pain. Diarrhea, generalized not feeling fell. On awakening 01/09/21, low grade fever of 99.9, chills, fatigue, generalized malaise,  brain fog, & confusion. I was in the shower & yelled for my husband to help me brush my wet hair & asking why it was wet. When I was brushing my teeth, I asked my husband to get me a toothbrush because I could not brush my teeth with "this noodle".  Doing "goofy" things on 01/09/21 & 01/10/21. Realizing I am doing this which is not normal. I am an RN & this is not normal for me. On 01/07/21 @ 6:30 pm took 50mg Benadryl, 200mg Advil & Tylenol
8/27 Complained abdominal pain AM and PM  8/28 Watery diarrhea starting 2 AM Fever 100 F 8 AM, ibuprofen given
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The nurse reported that the patient was an expired dose of GARDASIL, lot # 658490/0802U, expiration date 05-APR-2010 (dose and route not reported) on 25-AUG-2010. No adverse effects were reported. Additional information is not expected.
told the immunizer before hand that she gets faint with vaccines/needles.  The immunizer administered the vaccine and asked the individual if they were all right after.  She said she was.  She waited in the waiting room and then started feeling ill.  She ended up passing out on the floor.
Pt. states that  "I am having a little trouble swallowing"  12:34pm  Benadryl is administered 20   ml po. Stated she felt better after taking benadryl.  Stated she thought she was nervous. Pt was able to drink water, several sips.  Vitals:  12:29pm  130/79  101 18  O2 98%.  12:34pm  122/72  85  16  O2 98%.   Disposition:  Pt. left at 12:45pm with husband. Steady gait, unassisted, calm and cooperative.
woke up with major headache, nausia, mid back and chest pain.  Slight fever whole body ache.  Not very functional, slept alot.  Stayed in bed since my whole body felt awful.  All this in middle of major blizzard.  Sunday felt a little better.  Still feel off
Second dose of MMR vaccine.  Only shot received.  Red, swollen, red, hard, sore to touch welt just below injection site immediately after shot administered. Approx 2 inches in diameter, also with red streaking. After 2-3 hours, streaking was gone and welt increased in size to 3 inches in diameter. Sore to touch but not painful. Called doctor following morning, 03/17/16, and they advised warm compress and motrin for pain. Do not seem concerned or care at all.
Received Typhoid with Yellow Fever in left arm, within 24 hours hives appeared in armpit spreading to left side of trunk. Also experienced extreme weakness and aching "all over". Went to minor med and received steroid injection and dose pack. Symptoms slowly resolved after 72 hours.
Positive for COVID 19; Positive for COVID 19; Breakthrough infection; This is a spontaneous report from a contactable other hcp received via a sales representative. A male patient of an unspecified age received BNT162B2 (Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had breakthrough infection and found positive for COVID-19 on an unspecified date. It was reported that event took place after the use of product.  The patient underwent lab tests and procedures which included, on an unspecified date, SARS-COV-2 test: positive.  The outcome of the events was unknown.  The lot number was not provided and will be requested during follow up.
Vaccine administered at clinic.  Pt is a 24yo male who received the J&J vaccine on 4/8/21. On Day 1 reported having mylagias, chills and pain at the site of injection. Symptoms resolved the next day and for two days had no other symptoms other than pain at the site of infection. He presents today, 4/13/21, with acute onset of shortness of breath this morning with cough as well as one episode of NBNB emesis at home. Rapid COVID test negative. no hypoxia, including ambulatory. exam and vitals reassuring.
Information has been received from a physician concerning an approximately 25 week old male who on 21-JAN-2008 and 21-MAR-2008 was vaccinated PO with his first and second 2.0 ml doses of ROTATEQ.  On 15-MAY-2008 the patient was hospitalized due to severe dehydration due to a positive rotavirus test.  The patient was still hospitalized and was not recovered at the time of this report.  There was no product quality complaint.  No further information was provided.  Severe dehydration and positive rotavirus test were also considered to be immediately life-threatening by the physician.  A lot check has been initiated.  Additional information has been requested. 8/28/08-records received for DOS 5/15-5/17/08-DC DX:Dehydration. Rotavirus with vomiting, dehydration, diarrhea and acute gastroenteritis for one day, decreased appetite and decreased sleeping and fussy. Temperature of 101.
Patient received their vaccine at 5:12pm and at 5:15pm felt light headed, sweaty, and spaced out. He did not faint, he did get back to baseline after drinking a bottle of water, and resting .
This spontaneous report as received from a 62 years old male patient concerning himself with arthritis and no drug reactions or allergies. The patient was vaccinated with a dose of ZOSTAVAX on 11-SEP-2012 (lot #, dose and site of administration were not provided). No other co-suspects were reported. Concomitant medications included: diclofenac sodium. The patient mentioned that he had the ZOSTAVAX twice. He mentioned he felt the nurse injection the first vaccine deep the muscle causing pain. The nurse noticed he complained about pain and quickly administered another dose. This time he mentioned it was under the skin because he did not even feel it. The patient did not seek medical attention. At the time of the report, the patient's outcome was unknown. Additional information is not expected.
Medication error.  Client was given Pediatric Formulation Pfizer Covid vaccine product in error.  Client immediately given age appropriate Pfizer Covid vaccine.
Fatigued; Chills; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigued) and CHILLS (chills) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (fatigued) and CHILLS (chills). At the time of the report, FATIGUE (fatigued) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.