chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SHE BEGAN TO COMPLAIN OF JOINT PAIN AND MUSCLE PAIN IN HER KNEES AND LEGS. CALLED THE PHONE NURSE AND WAS TOLD THAT IT WAS PROBABLY JUST GROWING PAINS TO TAKE SOME TYLENOL AND ADVIL. THESE SYMPTOMS CONTINUED AND THEN SHE RECEIVED HER SECOND DOSE AND THEN THE FINAL DOSE ON 12/21/2012. THOSE SYMPTOMS CONTINUED AND THEN SHE STARTED TO BECOME DIZZY AT TIMES WHEN SHE WOULD STAND FOR TOO LONG OR GO FROM A SITTING TO A STANDING POSITION AND AS THE MONTHS WENT ON SHE BECAME MORE AND MORE FATIGUED. BY NOVEMBER OF 2014 HER DIZZINESS BECOME SO SEVERE THAT SHE PASSED OUT IN THE SHOWER AND WE THOUGHT SHE HAD A SEIZURE AND IT WAS NOT IT TURNED OUT TO BE POTS.
10cmx11cm area of induration and erythema at site of injection within 24 hours of injection. No fever.
Hep A given 6/25/18 on (L) thigh. The following day, pt developed hives around injection site. Taken to ER, given BENADRYL, rash resolved (no other symptoms). Hives returned the next day on legs and arms, given BENADRYL, resolved. No other symptoms.
This is spontaneous case, initially received form a pharmacist on 15-Nov-2018, concerning a 62-year-old, adult male patient. On 14-Nov-2018, the patient (under age of 65 years) was administered FLUAD (TIV) [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 250789 and expiry date: 31-May-2019] (explicitly coded as inappropriate age at vaccine administration). The patient did not experience any adverse events after vaccination. The reporter assessed the case as non-serious. Follow-up report received from a pharmacist on 26-Nov-2018: The dose (0.5 ml), route of administration (intramuscular) and anatomical location (deltoid) of the suspect vaccine were added in product tab. The reporter confirmed that, the patient did not experience any adverse events after vaccination. The narrative was amended accordingly.
developed cough and congestion 11/30/2021. Tested at an urgent care on 12/03/2021. Admitted to Hospital on 12/03/2021. having issues with pacemaker and on oxygen currently. Currently still hospitalized as of 12/07/2021.
pt recvd vax; 22jul95 devel localized cellulitis & one ulcerated lesion on back;vesicles ruptured w/ central ulceration & sec infect;tx w/ erythromycin;27jul95 recovered;had a sibling w/ a gen vesicular eruption;
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 49 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17May2022) positive, notes: Antigen test. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt experienced fever, headache, vomiting, dizziness, sore throat, and tiredness. Duration unknown. Symptoms fully resolved.
Provider prescribed/ordere Bexcero Men B vaccine for patient, MA cancelled order because that vaccine not carried in clinic and placed an order for MEN ACYW Vaccine. Showed Provider who did looked at label for expiration, there was no communication on the switch, and provider did not see the difference in name. Vaccine administered. This would be the 3rd dose of MEN acwy for this patient. MA team caught error after and reported it to provider who called patient and let them know they received incorrect vaccine and an incident report was filed.
This spontaneous report as received from a Doctor of pharmacy refers to a female patient of unknown age. No medical history or drug reactions/allergies were reported. On 14-AUG-2013, the patient was vaccinated with the second dose in the GARDASIL series (Lot #, dose, and route not provided). The pharmacist reported that on an unspecified date, in August 2012, a year ago the patient received the first dose of GARDASIL series (Lot #, dose and route not provided). No adverse effect was reported. Additional information has been requested.
Hematuria. Fever associated w/ peak vaccinia viremia. Pt is a 25 yr old newly vaccinated female who developed low grade fever, hematuria and malaise Day 9, 10 and 11, peaking day 10/11 with Tmax 104F. Fever resolved day 12 with persistent achiness, arthralgias (symmetrical MP's, wrists, knees without edema or erythema) and discolored urine red, and now brown. No fever today or Monday. Recalls that she had a transient rash, in both axilla, as a ringed scaly red pruritic eruptions began Day 2 and resolved Day 4.  Denies SOB, chest or flank pain or palpitations, dysuria, or urgency. Has a remote history of UTI at age 18. No history of kidney stones. Takes no medications. Has regular menses and is not sexually active. Took ibuprofen once and aspirin twice for fever after urine was discolored. Today, day 13 reports mild bilateral wrist and hands arthralgias at MP's but not in PIP or DIP. Also reports bilateral knee pains and sterno manubrium joint. No erythema. No swelling or rash near these joints. Examination scabbing vaccinia lesion LUA with surrounding mild cool erythema. Residual curvilinear brown scaling dry skin appearing areas in both axilla. Joints are normal on exam except for minimal tenderness wrists and MP's when compressed. CV and abdominal exam are normal and there is no edema. Pt continues to feel better each day but her urine remains dark. She denies fever, dysuria, urgency, frequency or exanthem. UA today is essentially unchanged except LE is trace (25neg/ul and WBC's 7-15, RBC's 20-30. I spoke with pt and discussed my concern about this persistent asymptomatic hematuria. This is not a reported effect of Dryvax. Pt gave verbal permission for me to fax labs and notes and to discuss care with her PCP. Discussed my interest in renal ultrasound, nephrology opinion, and C3D immunoassay. Pt had appt tomorrow 0900.
c/o pain injection site then entire arm. Also said she had a metallic taste which resolved with drinking water   Observed longer. Continued to have arm pain but no red-ness or swelling. denies an other symptom. Discharged  ambulatory.
Miscarriage. April 1st. Estimated due date was November 10, 2021. First pregnancy.
Bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; No Adverse Event; Bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (Bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event) in an adult male patient 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 11-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Jan-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (Bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided      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 assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (Bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again).    This case included information of patient 91st out of 100 patients.  No concomitant medication was provided by reporter.  Nurse reported an adverse event 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again 100 adults male patients are involved, date of administration 11 Jan 2023, lot numbers unknown to the HCP.  No treatment medication was provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-697752 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752: case
First dose 12/10/21. Second dose 1/5/22. On 12/23, Patient had a fever of 101.7, runny nose, cough, fatigue. Was COVID negative. She was sick for a little over 24hrs. About 5 days later she started having episodic rashes. Her skin would turn bright red in blotchy areas and be hot to the touch. It was on every part form her ears down her torso. It looked very much like an allergic reaction, but couldn't figure out a source - no new foods, soaps, lotions, detergents or other exposures. This has continued intermittently since then. About 30min after her second COVID shot (1/5/22), her entire belly was covered with rash and was very itchy. She then had fever, fatigue, body aches for 48 hrs. She has still having the very reactive skin anytime her skin is rubbed. If skin is rubbed or scratched, will get red and warm.  Not significantly itchy though. No treatment tried. At recent clinic evaluation, advised that recurrent dermatographic hives could be related to vaccine, viral illness, or other environmental or idiopathic trigger. Recommended antihistamine treatment + allergist evaluation.
P.C. 955 05.26.11 Described having ring worms 3 days after injections. PMD to her to report here. Using OTC meds. topically.
Cellulitis and fever within 48 hours. Required hospitalization and IV antibiotics. Cellulitis left arm not focalized.  Fatigue, Myalgia, Headache. No additional terms added from Discharge Summary rec'd 11/10/2005/sr. Per follow up report-Had influenza vaccine without any adverse reaction.  Patient feels it was the pneumovax which started immediately with blisters. Discharge summary states neck pain, fatigue. msv
Adversely affected menstrual cycle.  Started period early. Extremely heavy period bleeding.  Still bleeding on 10/8/2021.
was always in the bed not wanting to do anything; Weakness; tired; Chills; sore arm; Swollen arm; Joint pain; Muscle pain; she was severely sick for 11 days; This is a spontaneous report from a contactable consumer reporting for herself. A 44-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on 31Dec2020 0930 at a single dose on the right arm for COVID-19 immunization. Medical history included ongoing cholesterol problems from 2019 (manages without medication) and colitis. Concomitant medications were not reported. The patient previously took doxycycline from Aug2020 to 30Dec2020 for colitis. The patient experienced muscle pain, joint pain, sore arm and swollen arm on 31Dec2020. She experienced weakness, tired, chills on 01Jan2021, and was always in the bed not wanting to do anything on an unspecified date. The patient stated she was severely sick for 11 days and stated her covid and flu test came back negative. She said she could not work and was off work due to the side effects. She had to go to urgent care also. She wanted to know about taking the second dose.  She was scheduled to get her second dose on 22Jan2021. She was sick with the first dose. She was weak, tired, had chills and was always in bed not wanting to do anything. She asked if these events will come back with the second dose and if it is possible to not get the second dose. She also reported that her arm was sore. She had joint and muscle pain. She tried to fight it. The weakness and chills continued off and on. She returned to work on 12Jan2021. She went to the urgent care and has also went to see her physician. She had lab work done. She also had a rapid Covid and flu test, both of which were negative. Outcome of weakness and chills  was recovering; outcome of sore arm and swollen arm was recovered on 04Jan2021; outcome of joint pain and muscle pain was recovered on 12Jan2021; outcome of tired was not recovered; outcome of "she was severely sick for 11 days" was recovered on an unspecified date; outcome of "always in bed not wanting to do anything" was unknown.   Information about batch/lot number has been requested.
For 2 days after injection, arm hurt, then stopped hurting.  Six days later, injection site started to itch, rash developed  (red and swollen).  1/11/21.  rash is gone but injection site continues to be red, swollen, itchy and painful.  Patient is using Benadryl cream topically for itchy area.  Arm continues to be swollen, red and painful to touch.
Subsequent to receiving first and second doses of Lymerix, pt experienced itching and blemishes. The most recent information reports the outcome of the event as unknown.
Felt okay after the shot. About an hour later started feeling a little light-headed. Tried to take it easy of course a little soreness in the arm. By about 10 I started feeling very dizzy everything moving slow motion almost. Spinning in the head. Nausea because the head is spinning. If I move up too quickly or bend over or walk. About 12 p.m. 24-hours after getting the shot on December 1st symptoms got worse. Gland under the armpit is swollen and hurts very bad feels like I have a baseball there even though it is not a baseball bump. Can't really feel anything unless I really pushed but that hurts too much. The arm injection site left arm of course is sore. When I stand up everything starts spinning dizzy. Have to move slow. It is now December 2nd at 3:30 a.m. and I am spinning and dizzy. I cannot lay down. When I lay down the symptoms get worse the spinning goes crazy. Sitting up in my recliner I'm able to shut my eyes and doze in and out a little bit but when I try and lay into bed the spinning of too much and it makes me sick I don't like that slow motion cloudy unclear minded feeling. I've had two other vaccination shots moderna as well. First one April 7th 2021, second one May 5th 2021 and this one booster on November 30th 2021. All moderna. Body aches and chills with those seem to be going away a bit. But the head spinning is relentless yeah. If I stay still then it's just a woozy dizzy especially if I keep my eyes open. So tired very tired but nauseated when closed eyes. I had several of the same reactions with the other two vaccinations but not this dizziness and spinning of the head. Last time I had massive headaches and body aches and chills. And a little light-headedness. Also my left gland under my ear swelled on the same side of the shot. This time it's under my armpit and I've got like I said this vertigo or whatever is going on this time. Is kind of concern I have not reached out to my doctor yet. I'm giving it another day unless by the end of today before they close it is not any better or it causes me even more discomfort I might call them or send my doctor a message to see what he thinks. I'm just trying to let it run its course I just want to make sure this gets on record.
This spontaneous report was received from a pharmacist referring to a female patient of unknown age. The patient's concurrent conditions included several unspecified allergies. Medical history was not reported. On 26-OCT-2015, the patient was vaccinated with ZOSTAVAX, subcutaneous, 0.65 ml, lot # reported as 1015414, expiration date 01-AUG-2016. The patient was taking several unspecified medications. Approximately, on an unspecified date in October 2015, the patient developed a "red raised area" around the injection site that is "3 inches across" after receiving ZOSTAVAX. The patient called the pharmacist on 27-OCT-2015 to report the event and went to the pharmacy on 28-OCT-2015 to show the pharmacist the injection site reaction. The pharmacist informed the patient to apply hydrocortisone cream (manufacturer unknown). Laboratories were not performed. At the time of this report, the outcome of the injection site reaction was not recovered. Additional information has been requested.
On March 8, 2023, I began feeling tired and had a slight fever, less than 100 and also a slight headache.  I mostly stayed in bed.  Friday, I felt worse and I had a higher fever.  I continued taking Tylenol. Saturday, I had a loss of taste.  Sunday, I felt a little better.  Yesterday I was able to do laundry but it wiped me out.  The symptoms continue to decrease.  Today I have a productive cough.  My fever disappeared Monday.  I am still fatigued.  I have not regained my taste all the way.  I communicated with my health care provider via my account online.
Tiredness; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 28Mar2021 at 04:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. The patient had a medical history of COVID-19. The patient did not have any allergies to medications, food, or other products. The patient did not take any other medications in two weeks of the vaccination.  Prior to the vaccination, the patient was diagnosed with COVID-19 on an unknown date. Since the vaccination, it is unknown if the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Mar2021, the patient experienced tiredness. The patient did not receive any treatment for the event. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event tiredness was not resolved.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Immediately following injection patient passed out and was diaphoretic with a low BP of 56/35. Became responsive but speech garbled and then experienced seizure (posturing and clonic movement) that lasted 3 seconds. Called 911, became responsive before EMS arrived on scene and refused ambulance.
24 hrs. experienced pain, redness, induration approximately 1 inch adjacent to injection site. Treated with Loratadine 10mg Qd and topical hydrocortisone cream.
So, the day was on the 1/29/2021 at 8am  and I got out the shower and I looked in the mirror and I noticed that my arm was red and had rash on my left arm where I received the vaccine. It was a little itchy and hot.    I called my insurance at 9am the same day and it was the nurse line and then I describe to the nurse the reaction  and the nurse suggested to check with my doctor or urgent care.  I arrived to the urgent care at 12:19 on  1/29/2021 and the doctor examined  the rash and my body to make sure it didn't spread and she determined it was localized to the injection.  The rash and the itching lasted for 3 days.
9/16/21 - patient sent to ED due to worsening confusion and hypoxemia. Recently tested positive for COVID-19 at his SNF. Determined to be in septic shock.  Patient was palliatively extubated and expired shortly after.
Patient has first dose of Pfizer and when he returns to his second Vaccination appointment, he is placed the Moderna, patient was kept under observation for 30 minutes and did not present any signs for symptoms. The nursing staff was In contact with the patient for several weeks to know if there were side effects from the vaccines.
Mom states that approximately 24 hours after immunization, patient broke out with an unusual rash on left thigh and lower leg that resembled "bug bites".  Afebrile, alert.  Lasted 24 hours.
OBSTRUCTIVE SLEEP APNEA CHRONIC HYPERCAPNIC RESPIRATORY FAILURE RESPIRATORY FAILURE, UNSPECIFIED ACUITY HYPOXIA
After the vaccine, the patient started to feel dizzy, lightheaded and had blurred vision. After assessing her, her blood pressure was taken and found to be 204/111.
pt recv vax 10FEB97 & 22MAR97 pt devel a gen rash;
Epilepsy; This is a spontaneous report from a Pfizer sponsored Program from a non-contactable consumer reported for patient (consumer's husband). A 71-year-old male patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration in Apr2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE, and first dose via an unspecified route of administration in Apr2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient received the first and second dose of Pfizer Covid-19 vaccine last April 2021 and wanted to get an appointment to get the booster dose. He had epilepsy as mentioned. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt vaccinated /w DTP/OPV developed grand mal seizure lasting about 5 min associated w/fever to 103.
Bilateral redness to toes, poor capillary refill. Pain including burning at the site. Swelling to feet.  Discoloration including mottled - red - pale.
Pt recvd 3rd dose in a series of hep B vax & on 13DEC90 exp "anti-HBS w/ SRU result: 8."
Atypical numbness to hands and feet.  Also complains of tinitis and positional vertigo
Shock/collapse syndrome same day. Thrombocytopenia within 3-4 days. Sudden decline in health-ear infections/upper respiratory (the next 4 weeks happened within 3 days) vaccination. Possible seizure three hours of jerking 21 days later.