chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient called the day after she had received a PNEUMOVAX vaccine stating that her arm was red, swollen, and it hurt to move it. I instructed her to take an antihistamine, ibuprofen and put some ice on it. I called back about 2 hours later to check on her and she stated that the medication did help but her arm was still painful. I asked her to come to the pharmacy so that I could look at it. The patient's arm was red, swollen, and warm to the touch around the injection site so I instructed her to go to urgent care. She was seen by a nurse practitioner who diagnosed her with cellulitis due to the vaccine and gave her an antibiotic. Upon follow up today around 5:00 PM she stated that her arm was still red, swollen, and painful. She is to see her family care physician tomorrow (8/22/16). I instructed the patient to continue with her antibiotic as well as ibuprofen, antihistamine, ice, and to elevate her arm until seen by her physician.
Shoulder pain; This case was reported by a pharmacist via call center representative and described the occurrence of shoulder pain in a patient who received Rabies NVS (RabAvert) for prophylaxis.   On an unknown date, the patient received the 1st dose of RabAvert. On an unknown date, unknown after receiving RabAvert, the patient experienced shoulder pain. On an unknown date, the outcome of the shoulder pain was unknown.   It was unknown if the reporter considered the shoulder pain to be related to RabAvert.  Additional details were provided as follows: The age at vaccination was not reported. The patient's demographic details were not provided. The pharmacist reported that, the patient experienced shoulder pain after receiving RabAvert for post exposure prophylaxis. The reporter was reluctant to provide more information. The reporter did not consent to follow up.
no aditional AE; patient ws vaccinated with VARIVAX that experienced a temperature excursion; This spontaneous report was received from medical assistant and refers to a 1 year-old female patient.  The patient's medical history, concurrent conditions were not reported. Concomitant medications included sterile diluent (manufacturer unknown).   On 18-AUG-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX)  lot #W003819, expiration date: reported as 24-FEB-2022 but upon internal validation was set as 02-FEB-2024, administered subcutaneously on the left thigh as prophylaxis (strength was not provided) following a temperature excursion of  14 degrees Fahrenheit (F) up to 46 F for 1 hour 30 minutes data logger involved (product storage error), it was mentioned that no previous temperature excursion occurred. No additional adverse event was reported.; Sender's Comments:  US-009507513-2208USA008462: US-009507513-2209USA008834: US-009507513-2209USA008720: US-009507513-2209USA008835:
Three days after vaccination I started sneezing, had a runny, itchy nose, arm was still sore at vaccination  site.   Felt like an allergic reaction or else I was getting a cold. Was feeling these effects for 24 hours.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY
Mom describes (L) arm became hot to touch, swollen red and painful from shoulder to elbow. She states that child still played like normal. She took him to M.D. who told her it was allergic reaction, give Benadryl
Patient is complaining of late onset injection site reaction. She is having side effects of a rash, swelling, raised bumps and itching.
The pt experienced right thigh swelling presented by parent on 4/18/01. Swelling increased as the day progressed. No abscess, no mass. Treatment was heat and ibuprophen.
cherry color pin point papules v.s every 4 hrs x 24 O2 sats
Day three when patient presented to pharmacy. Patient complaining of inflammation. swelling, pain and redness at and below the IMZ site. Symptoms have been decreasing over the last days since the IMZ was administered. Patient was informed to apply a cold compress to site, along with taking 25mg of Benadryl, and Tylenol weight based. Patient has not contacted the pharmacy again at this time.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about 06-AUG-2012 at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 17-AUG-2015, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed at herpes zoster, or shingles and post-herpetic neuralgia resulting in severe residual pain and nerve damage. The patient has been prescribed gabapentin and acyclovir for management of his painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Patient received vaccine the morning of 6-13-16 that evening he woke with hives to chest and wheezing. Patient given 25mg BENADRYL and albuterol. Went to ED. Symptoms resolved. Monitored in ED.
I Received the shot at 10:45am on April the 15th, no side effects except arm soreness afterward. Then at around 7:40pm that same night, I began getting terrible itchy on my face, back, arms, and neck. It worsened and I started having trouble breathing (it felt like my throat had tightened)/a hoarse voice, and my pulse was faster than usual and I felt woozy and tired.. I called a nurse hotline and she recommended for me to be seen at an ER, and I went home to tell my parents and they called a doctor friend, and I was told to take Benadryl and if anything got worse to go to the ER. The next day when I woke up I felt mainly tired and had a slight cough and was scheduled a telehealth appointment, and I am taking Zyrtec 10mg and Pepsin 20mg daily x one week with Benadryl as a back up in case the symptoms flare up, and am advised to go to the ER if the breathing issues return. In terms of symptoms now, I am just a little itchy.
spontaneous abortion p/MMR & Td @ 8wks gest; LMP 17MAR95; vax given 28MAR95
A few days after I received the vaccine I noticed a rash on my left arm that soon became itchy. A few days later the rash was on my stomach and itchy and again a few days later on my left leg. I was overseas at the time and when I arrived home about 2 1/2 weeks after the shot, my doctor prescribed prednisone. Cleared up.
On 05/19/2022, I woke up with a sore throat, congestion, sinus drainage and fatigue. I gave myself a home test that came back positive. 05/20/2022 - I had a confirmation test at the local pharmacy, a rapid antigen test just to confirm it was positive. I spoke to my doctor, and he prescribed Paxlovid, and it worked great. On 05/20/2022, I had to take a few a naps because I was so tired. Right now, I am feeling normal.
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions and allergies was unknown. Concomitant therapies included sterile diluent. On an unknown date the patient was vaccinated with improperly stored ZOSTAVAX vial 19400PFU (dose, units and frequency were unknown), (Lot# N025704 and expiration date 16-DEC-2018) (Lot# N025701 and expiration date 16-DEC-2018) for prophylaxis. The temperature excursion details were provided. The temperature was 6 F to 14 F (7 F). The previous temperature excursion was at 14 hours. The call was because of a digital data logger. On 21-FEB-2018, it was reported that the product was difficult to reconstitute. The Pharmacist reports that it was not noticed that the previous ZOSTAVAX from those lots were difficult to reconstitute. No adverse effects were reported.
After administration patient felt light headed and dizzy and needed to lay down for a few minutes. Patient felt well enough to leave on own and refused EMS.
HEADACHE; This spontaneous report received from a patient concerned a 42 year old female. The patient's weight was 155 pounds, and height was 62 inches. The patient's concurrent conditions included diabetes, non-smoker, and non-alcoholic, and other pre-existing medical conditions included patient does not abuse drug or illicit drug use. The patient experienced ibuprofen allergy when treated with ibuprofen.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and  expiry: 23-JUN-2021) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 13-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache. This report was non-serious.
This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. Patient medical history and current condition was not reported. On 15-APR-2015 the patient was vaccinated with ROTATEQ oral liquid (unknown dose and Lot number) orally for prophylaxis which underwent supported temperature excursions. Reporter stated that since 8-APR-2015, the doses of ROTATEQ underwent supported temperature excursions. No adverse effects reported. The outcome of the event was unknown. This is one of the 5 reports received from the same reporter. Additional information has been requested.
Initial report was received on 19 August 2011 from another manufacturer national service center (service request number 1-4408792546). who received the report from a consumer. A 37 year-old female patient with an unreported past medical history had received a "DTP vaccine" (manufacturer, lot number, route and site of administration were not reported) on 11 May 2011 and an unspecified amount of time later, developed itching on her palms. The patient also developed hives, but not immediately after vaccination. She gradually started with itching on her palms. She was evaluated by her physician. Treatments included cortisone therapy. The hives persisted for a month and eventually the hives cleared up after starting treatment. No further information was provided at the time of the report. The patient's outcome was reported as recovered (date not reported). Documents held by sender: none.
No additional adverse effects reported; the patient was administered improperly stored PROQUAD; Information has been received from a medical assistant, referring to a patient of unknown age and gender. Concomitant therapies included sterile diluent. The patient's pertinent medical history and drug reactions/allergies were not reported.  On 19-MAR-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, dose and route were unknown, lot# R020678, expiration date 15-JAN-2020) for prophylaxis, which was reported as improperly stored (temperature (32.57 degrees Fahrenheit) 15 degrees Fahrenheit to 46 degrees Fahrenheit, time frame was 22 hours) (product storage error). There was no previous temperature excursion. Data logger was involved. No additional adverse effects were reported.
initially, nausea and "weird" feeling for approximately 12 hours.Tthe injection site continued to be uncomfortable , and on 8th day after injection, the injection site began to itch. On 9th day, there was intense itching, and injection site began to swell. by 10th day (today), the swelling and itching is subsiding, but not gone.
My mom had a fever, chills, aches all over, sore arm, and had 2 days of memory loss/crazy behavior.  It was almost as if she had dementia - she repeatedly called myself and my daughter claiming that her phone didn't work and she needed help. She was trying to tell me a phone number but kept giving me random words instead.  She doesn't remember talking to any one of us who spoke to her Saturday and Sunday. She was repeatedly asking what a specific button did on her TV remote, and would then ask again a few minutes later the exact same question. This went on for 2 days.
Bad, worst sore throat ever, swollen tongue, bumps all over tongue, fatigue, general muscle aches
Initial information received on 16-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 61 years old male patient who was inadvertently administered a 0.5 mL dose of FLUZONE HIGH DOSE lot UI977AB, expiry date: 09-Mar-2019 via intramuscular route in the left deltoid on 11-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to inappropriate age at vaccine administration and overdose. It was not reported if the patient experienced any administered or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
The next day she stated on her left side under her arm her lymph node became swollen. She called her dr office and spoke with a nurse. The nurse told her to take IBuprofen.
26 hours after the 2nd injection - body aching, chills, fatigue, weakness and mild headache .  By the morning these symptoms resolved
Patient is complaining of profound fatigue for the past five (5) days since his vaccination, He states that he has been unable to leave his bed since he got is shot. Also reports , left arm pain (vaccination site). stiffness. Today he is ambulating with a walker (typically uses a cane).
No additional AE reported; 4 year old patient received GARDASIL 9 today 3/13/2023; This spontaneous report was received from a medical assistant referring to a 4-year-old patient of unknown gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 13-MAR-2023, the patient was vaccinated with hpv rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (lot#: w004648, expiration date: 06-OCT-2024; strength, dose, route of administration, and anatomical location were not reported) for prophylaxis (product administered to patient of inappropriate age). No additional adverse events (AE) were reported (no adverse event).
pt recv vax & exp sz x 30-45xeconds;described face as becoming very red during;pt stated it's really black;pt couldn't see;pt very quiet & had sz;mom shook pt very hard during the sz;pt sl pale;
redness & puffiness around inj site that radiated to cover about half of thigh;no tenderness or warmth @ inj site;instructed w/DPH po & cool compresses to area;
Full body aches; Sleepy; Pain in arm; Tired; Headache; This is a spontaneous report from a non-contactable consumer, the patient. A 36-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727), via an unspecified route of administration in the arm left on 28Mar2021 at 12:45 (at the age of 36-years-old), as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 28Mar2021 at 16:00, the patient experienced pain in arm, full body aches, tired/sleepy and headache. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events pain in arm, full body aches, tired/sleepy and headache were recovered on an unknown date in Mar2021.  No follow-up attempts are needed. No further information is expected.
Tinnitus (ringing in both ears) started after the second injection and has continued for over a year.  No treatment available per consultation with 2 hearing specialists.
Pt experienced a local reaction within 24 hrs at the site of injection, described as a bullseye, after receiving influenza virus vaccine.  Also observed was supraclavicular swelling including lymph nodes.
Pt complained of dizziness and a severe headache approx. 30 minutes after vaccination.  The following day she reported her arm became sore, red, warm and itchy.  She also reported a welt the size of a half dollar that was raised.
I had severe menstrual  bleeding, soaking thru tampon every 30 minutes. I went to the ER and got a CBC test and it was normal.  My menstrual  cycle was off the next month. My Cycles have been early .
patient got dose 1 prior at age 45 and dose 2 at age 46 (out of pharmacist standing order). no adverse effects occured.
Monday afternoon he manifests foot pain especially on the left one and difficulty at walk. On Tuesday morning he manifest throat discomfort continues with legs pain, inflammation and difficulty to walk. He has two red bumps on the bottom of the left foot and was painful to the touch. Take him to urgency room on the afternoon they take left foot radiography, make a COVID-19 test and injected him with Toradol. Still with foot and legs pain and difficulty to walk but the Dr. send him to see the pediatrician. On Wednesday he had the leg pain, difficulty to walk and hands and arm pain. He can?t raise his arms due to pain. Also present itching on foots and what looks like skin rash. Take him to Emergency room on the afternoon were they run laboratories and administrate anti-inflammatory medication by vein we reflect a skin rash on chest and the administer Benadryl too. He manifest improvement and lest pain in approximately 4.5 hours later.
pt was about to fainted after about 1-2 min after injection. Pt felt so dizzy. was about to faint. i ran to grab his arm and help him not to fall while my staff called 911. pt kept complained about the severe dizzyness. his puse was ok but his blood pressure dropped to 95/72 .  911 EMS  took him to hospital to get stablizer his pressure and to monitor until he feel ok
Was like passing out briefly; Fell down losing total control three times the morning after taking second done; Injured my head scare; Bruises on my shoulder and hip; Concerned me a lot; Injury my head scare; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Was like passing out briefly) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (Was like passing out briefly) (seriousness criterion medically significant), FALL (Fell down losing total control three times the morning after taking second done), HEAD INJURY (Injured my head scare), CONTUSION (Bruises on my shoulder and hip), ANXIETY (Concerned me a lot) and FEAR (Injury my head scare). At the time of the report, LOSS OF CONSCIOUSNESS (Was like passing out briefly), FALL (Fell down losing total control three times the morning after taking second done), HEAD INJURY (Injured my head scare), CONTUSION (Bruises on my shoulder and hip), ANXIETY (Concerned me a lot) and FEAR (Injury my head scare) outcome was unknown.            Concomitant product used was not provided by the reporter.  Treatment information was not provided by the reporter.  Patient Fell down losing total control three times the morning after taking second dose.  Action taken with mRNA-1273 was not applicable.  Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Extreme nausea,; Diarrhoea; Vomiting; This is a spontaneous report from a non-contactable consumer, the patient. A 31-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 04Jun2021 at 10:30 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unknown date in Jun2021 the patient experienced extreme nausea, diarrhoea and vomiting. The clinical outcome of the events extreme nausea, diarrhoea and nausea were unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Tested positive for COVID; This spontaneous report was received from a healthcare business professional referring to a male patient of unknown age. Patient's concurrent conditions, medical history and concomitant medications were refused to be provided.  On an unknown date the patient was vaccinated with first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (Lot # and expiration date and anatomical location were not provided) for prophylaxis.  Reporter stated the patient was scheduled to get the second shot of vaccine to go to school but on 06-JAN-2022, the patient tested positive for COVID. No additional AE. No PQC.  The outcome and causality were not reported.
He had the onset of respiratory complaints, hemoptysis. Led to CT Scans, biopsy. It returned no infection or cancer
Slight chills and low-grade fever, began 3 PM, worsened slightly in AM, gone by 9AM Muscle aches (arms, legs) during the night (10 PM - 4 AM) then gone Fatigue beginning 6 PM, gone by 9AM No treatment other than 1 aspirin in AM (night) No symptoms after 9 or 10 AM
The night of the shot, I began coughing, and I was extremely fatigued and coughing for about 48 hours.  Things improved, and on Thursday, March 25th, I started having bad abdominal pain around 10:30 am.  I went to urgent care, and the doctor suggested inflamed bowels, possibly from COVID/Moderna shot.  On Friday around 6 pm (next night), the abdominal pain was almost gone, and the COVID rash (red circle arm) appeared.  It was hot and inflamed.  I could barely manage to move on Saturday with extreme fatigue.  I didn't think I had a temperature, but it turns out my thermometer was broken.  My fever this morning was 100.
24FEB93 pt's mom called reported reaction to vax LAT; 22FEB92 vax given in AM pt awoke in afternoon from nap; c/o pain lt leg, t104; red streaks to the side & below inject site; seen by MD dx reaction to shot; poss begining of infect;
5 hours after administration developed severe left sided hip pain, skin sensitivity, leg paresthesia's and weakness.  Progressive pain up to back and down to knee after that, weakness led to several falls.  Malaise, diarrhea.
Tonic clonic tremors after vaccines, 20 seconds, pale, lethargic x 10 minutes.