chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a consumer refers to her 80 year old mother. The patient had shingles when she was younger (date not specified). "Last Wednesday", on 13-MAR-2013 the patient was vaccinated with ZOSTAVAX (lot number, dose, route and injection site were not reported) at the Pharmacy (location and telephone details not specified by the reporter). A couple days later in March 2013 both hands of the patient developed blisters and became swollen. No information was provided on the patient's current condition by the reporter. The outcome was unknown. Action taken and causality were not provided at the time of report. The patient did not seek any medical attention. Additional information has been requested.
Red rash, hard, warm to the touch, itchy. Onset 7 days after vaccine.
This spontaneous report was received from a physician refers to a patient of unknown age and gender. The patient received the first dose of GARDASIL (lot number, expiry date, route and dose were not reported) on an unknown date in March 2007. The second dose of GARDASIL (lot number, expiry date, route and dose were not reported) on an unknown date in May 2007 and was in the office on 02-JAN-2013 (reported as today) for receiving the third dose of GARDASIL (lot number, expiry date, route and dose were not reported). No concomitant medications were reported. No adverse event reported. Additional information is not expected.
After getting the Moderna COVID-19 VACCINE EUA, I only felt a little pain at the site of the shot. However, several days later, it started to itch and I scratched my arm at little. Later, I looked in the mirror and there is a large area around the shot site that has turned red, and even a little area beneath it. It still itches.
Mother called to report child developed "cruddy sounding cough" for 2-3 days after administration.  Child told mother he wanted to cough right after administration but couldn't cough and throat felt "funny".
Parent states five days after vaccines were given approx 8PM child had a seizure. Child was taken to ER childs temp 104.5. Fluids given IV/ chest x-ray and given Tylenol and Ibuprofen alternately. Child was observed for several hrs then released with parents.
Patient had complaint of sore arm 1 week post immunization.  Patient reports today (01/09/2020) that underside of arm is still stiff and had limited mobility without pain.
My mother presented with lower back pain several days post first dose of vaccine.  Three days after the pain started, she developed a rash that was diagnosed by her general practitioner as shingles.  The pain and rash lasted for 5 weeks.  The rash was extremely painful the first week and she was very fatigued.  She was given a prescription for Valacyclovir at the time of diagnosis which was a week after the pain started and 3 days after the rash erupted.
Around 9:30 pm April 1st, started with cold chills, Fever of 103 with full body aches, broke at 12:30 am.  Rest of the night very achey all over and bones hurt, unable to sleep.  Headache set in in the middle of the night then turned into a migraine. Arm sore where vaccine was administered & developed a small rash on the front of the bicep in the shape of a "Y". Really tired the whole next day. After a day of rest felt better and more myself by the 3rd day.
Weakness, Shortness of breath, elevated troponins, acute renal failure - Diagnosis per neurology Guillane Barre 2' vaccination? - Patient received plasmaphoresis x5 days, required intubation and subsequent trach and PEG and discharge to SNF.
The patient stated that she had her ZOSTAVAX injection on Tue Aug 2nd. Today when she woke she noticed she has a 5 inch welt in the location of the injection. Recommended patient call her dr.
This spontaneous report as received from a other health professional (healthcare worker) refers to a unspecified number of patients of unknown age. Current conditions and medical history was not reported. On 03-DEC-2014, the patients were vaccinated with (Oka/Merck) VARIVAX injection, lot number K003414, expiry date 06-MAR-2016 (dose,route and frequency were not reported). Concomitant medications were not reported. Starting on 24-NOV-2014, the doses of (Oka/Merck) VARIVAX were exposed to a supported temperature excursion of 17.8F for 93 hours. According to the Prescribing Information for (Oka/Merck) VARIVAX, the (Oka/Merck) VARIVAX should be frozen between-58F and +5 F (-50 C and -15 C). Use of dry ice may subject (Oka/Merck) VARIVAX to temperatures colder than -58 F and +5 F (-50 C and -15 C). Use of dry ice may subject (Oka/Merck) VARIVAX to temperatures colder than -58F (-50 C). Based on the information and assessment data, these (Oka/Merck) VARIVAX should be used within three months. No adverse effects were reported. The outcome was unknown. Product quality complaint was not reported. No additional information was provided. additional information has been requested.
Patient is a 15 yo female with a history of anxiety, recent ankle sprain, and no other known medical history who presents to ED today after she developed persistent shaking movements after her COVID 19 vaccination today. Medical work up has been thorough and has resulted negatively, including blood work, UDS, CT Head. She has remained slightly tachycardic, though she has also been moving continuously for several hours. Her physical exam is notable for several indicators of psychogenic origin, including demonstrating variability in tremor frequency (head, legs and arms vacillating it variable rates over time), distractability from motor tasks (head or arms stop shaking when asked to focus on moving her legs, for example). Her speech has also been affected, but this is also variable and she is at times using only 1 word sentences and other times responding more completely. Certainly she may have suffered a psychological stress today as she is fearful of needles and has a history of vasovagal response and her mother notes recent overwhelm with school performance, though this is not unusual for her. If medical work up continues to be negative, it may be reasonable to conclude she is suffering a conversion disorder  "FINAL DIAGNOSIS: Conversion reaction after a Covid 19 vaccine. Patient To be transferred via ground ambulance."
This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 46-year-old female patient who received FLULAVAL QUADRIVALENT. Previously administered products included Influenza vaccine (received 2 vaccinations in the past without issue). On an unknown date, the patient received FLULAVAL QUADRIVALENT (intramuscular) .5 ml. On an unknown date, immediately after receiving FLULAVAL QUADRIVALENT, the patient experienced injection site pain and joint range of motion decreased. The patient was treated with Acetaminophen, ibuprofen and Methylprednisolone Dose Pack. On an unknown date, the outcome of the injection site pain and joint range of motion decreased were not recovered/not resolved. The reporter considered the injection site pain and joint range of motion decreased to be almost certainly related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: The age at vaccination was not reported. The patient received FLULAVAL QUADRIVALENT in the deltoid muscle. The patient experienced decreased range of motion of the vaccinated arm and pain in arm. The patient did not experienced other injection site reactions or general reactions (no redness, swelling, chills, fever, or signs of infection). The patient was treated with acetaminophen and ibuprofen with no success. The patient received methylprednisolone dose pack (a 6 day taper). The healthcare practitioner reports that on the examination of patient, her passive range of motion was fine. The patient had limited active range of motion. The patient required emergency room visit.
ADMINISTERED SOME OF THE VACCINE (PARTIALLY ADMINISTERED); This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced administered some of the vaccine (partially administered). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered some of the vaccine (partially administered) was not reported. This report was non-serious.
she as given the vaccine within 7 days for receiving the MAB.  Should have been screened and waited 90 days before vaccine dose was given.
Patient experienced a large red circle around the injection site starting 24-48 hours after the vaccination. Patient states area is warm to the touch and hurts a little. Advised patient to use OTC pain relievers and Neosporin on the site (after verifying no allergies to medication). Told her to alert her physician if condition worsens or becomes bothersome.
This case was reported by a healthcare professional and described the occurrence of crying in a 6 week-old male subject who was vaccinated with PEDIARIX, (GlaxoSmithKline).  Previous and/or concurrent vaccination included HIB vaccine (Merck) and PNEUMOCOCCAL vaccine (Wyeth).  On 18 May 2007 and 28 August 2007 the subject received 1st dose and 2nd dose of PEDIARIX (.5 ml, unknown) in the left leg.  On 18 May 2007, less than one day after vaccination with PEDIARIX, the subject experienced crying.  The constant crying lasted for 5 hours after vaccination with PEDIARIX and then resolved.  On 28 August 2007, the subject received the second dose of PEDIARIX and experienced constant crying for five hours after vaccination with PEDIARIX.  Further doses of PEDIARIX were delayed and then discontinued due to these events.  Following a dose of tetanus and diphtheria (unknown manufacturer) on 07 November 2007 there were no reports of crying at the time of this report.  The reporter stated that the physician believed that the crying was caused by the pertussis component of the PEDIARIX.  Medical attention was not required.  At the time of reporting the outcome of the events were resolved.  The healthcare professional considered the crying was probably related to vaccination with PEDIARIX.
Information has been received from a physician concerning a 2 month old male who 2 months ago, was vaccinated PO with his first 2.0 ml dose of ROTATEQ.  The patient experienced severe diarrhea within 24 hours of receiving the vaccine.  The patient contacted the physician for medical attention.  The outcome was unknown.  No further information is available.  There was no product quality complaint.  Additional information has been requested.
Within 10 minutes, a floor assistant came to get the pharmacist stating patient had "passed out."  Pharmacist immediately went to patient and she was sitting in a chair in the aisle, upright, breathing, semi-conscious, pallor face.  After about 1-2 minutes, patient started to have a seizure that lasted about 5 seconds.  Pt was breathing throughout.  Post-seizure patient was confused for about 5 minutes.  After 5 minutes, she recognized her daughter and son-in-law who were caring for her and the pharmacist that administered the vaccine.  We attempted to check her BP but her sweatshirt was too thick and we could not get a reading. Pt felt warm and we placed a cool cloth on her forehead.  After about 10 minutes, she was feeling much better, her normal color had returned.  She was wheeled in a chair to her car where her daughter and son-in-law brought her home.   *While speaking with daughter while monitoring patient, she stated her mom had one seizure about 3-4 months ago which resulted in a hospitalization for 1 week with multiple tests being run and no identifiable cause found.
After vaccine the following day Friday 5/28 I had COVID flu like symptoms and right arm very sore for 24 plus hours until Wednesday 6/2 stopped. Than woke up Friday 6/4 early AM with swollen right arm, purple and reddish in color.. Continued on through Sunday morning 6/6 went to ER  at 9 am. treated for deep vein thrombosis, blood clot found in right arm and given an injection of Eliquis to the stomach to last 24 hours until Eliquis tablets starter pack.  My arm is still swollen and bruised now at vaccine spot, today Friday 6/11 scheduled to see a Hematologist  Dr. MD 6/14 I am very concerned and don't understand.
Grandma states pt had welts on entire body day p/shot; PE erythematous, urticarial type sploches on face & back;
Myopericarditis suspected to be 2/2 to vaccine.; This is a spontaneous report from a non-contactable physician. A 28-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration on 02Mar2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient has no COVID prior to vaccination. The patient experienced myopericarditis suspected to be "2/2 to vaccine" on 04Mar2021. The event resulted in hospitalization. The patient was not tested for COVID post vaccination. The outcome of the event was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
I noticed a small section of a rash/hive on my right hip in the morning. Later that day, after the vaccine, there was a spot on my right hand, between my fingers that started to itch. Then from that time until this morning (3-22-21), I have had more locations and more intense itchiness with the hives.
Sudden Sensorineural Hearing Loss in the left ear, including tinnitus and diplacusis.  Treated 24 hours after onset with 500mg IV methylprednisolone from Dr. Repeated 45 hours after onset with 500mg IV methylprednisolone.  Prescription of 500mg Trental q.d.  The hearing normalized after several weeks.
Had a pain that was all the way around my torso and it collected on my right side. When it did not go away I went to my PCP to have it checked out and it was initially determined that it may be a pulled muscle. I did not feel like it was and saw my oncologist for a test and asked if this could be the cause. I went to an imaging facility to get a PET/CAT scan done. Found that I had inflammation of the soft tissue near the lungs. Nothing given yet for treatment and was referred to another doctor to determine best course of treatment.
3:12pm - patient complained "spinning of the room". patient was alert and calm. vital signs stable 100/60. heart rate of 86.  3:20pm - patient insisted to go home by herself. she refused to go to hospital or contact family member to be picked up. patient still alert and calm.  3:35pm - patient left by herself. signed leaving sheet.
6 hrs after shot: nausea, diarrhea, dizziness 10 hrs after shot: previous symptoms went away but developed low fever (99.8)  The day after the shot: Neck pain and stiffness, body aches, sharp pains that would come and go in different body parts, fatigue, fever up to 101.  All symptoms gone by 48 hrs post vaccine.
swollen left ankle; red hot spot which 2 inch high and 2 inch wide at injection site; Unexpected return of red left arm much larger then before and much larger area; Feeling sick all day; Vaccination site hot spot; Little painful; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Vaccination site hot spot), VACCINATION SITE PAIN (Little painful), VACCINATION SITE ERYTHEMA (red hot spot which 2 inch high and 2 inch wide at injection site), ERYTHEMA (Unexpected return of red left arm much larger then before and much larger area) and JOINT SWELLING (swollen left ankle) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LOSARTAN POTASSIUM (LOSARTAN) for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced VACCINATION SITE PAIN (Little painful). On 05-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Vaccination site hot spot). On 21-Feb-2021, the patient experienced MALAISE (Feeling sick all day). On 24-Feb-2021, the patient experienced ERYTHEMA (Unexpected return of red left arm much larger then before and much larger area). On 07-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (red hot spot which 2 inch high and 2 inch wide at injection site). On an unknown date, the patient experienced JOINT SWELLING (swollen left ankle). On 25-Jan-2021, VACCINATION SITE PAIN (Little painful) had resolved. On 23-Feb-2021, MALAISE (Feeling sick all day) had resolved. On 25-Feb-2021, ERYTHEMA (Unexpected return of red left arm much larger then before and much larger area) had resolved. On 12-Mar-2021, VACCINATION SITE ERYTHEMA (red hot spot which 2 inch high and 2 inch wide at injection site) had resolved. At the time of the report, VACCINATION SITE WARMTH (Vaccination site hot spot) and JOINT SWELLING (swollen left ankle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: ADR form received: Additional 2 events added, outcome of 3 events updated, concomitant medication added and patient address updated
The next day I experienced pain in my arm and my back was hurting to the point I couldn't sit up straight up until about 1pm. I also experienced hive breakouts. I messaged my physician and she informed me it was and adverse but normal reaction. It lasted for about 48 hours. It was a 9 on Thursday and a 6 on Friday. I took naproxen over the first 24 hours of pain.
PATIENT FAINTED RATHER QUICKLY AFTER VACCINE ADMINISTRATION. WAS IN AND OUT FOR SEVERAL MINUTES. PARAMEDICS CAME TO CHECK ON HER AND THEY RELEASED HER AFTERWARDS.
About 2.5 months after vaccination, I started feeling very tired and had a lot of coughing. I had no energy for several weeks. I was taking my nebulizer at least every 3-4 hours. I tried taking OTC Sudafed. I ended up with a sinus infection. Starting the second week, I called my doctor and I was started on Azithromycin. It helped slightly but my asthma was still out of control. After almost 2 weeks, I ended up having to call my allergist and he prescribed me two different rounds of prednisone before my asthma started getting better. I was sick for a month. I tested positive for Covid 6 months after 3rd vaccine.
FLUVIRIN administered on 10/31/14 at 10:30. Administered in left deltoid muscle IM. The following morning patient experienced a bruise on left upper chest/shoulder area. Bruise is about 2 inches round and lump the size of a pen. F/U with pt with pt 2 weeks later, bruise has gone but lump remains.
PT C/O ITCHY THROAT AFTER DOSE. GIVEN ZYRTEC, VOMITED. EPINEPHRINE IM GIVEN, REPORTS FEELING BETTER
After having very minimal discomfort after the shot. A week later, my arm started getting itchy and my face was feeling very warm (I also have hot flashes so the face might be attributed to that) When I looked at my arm I was surprised to see that I could see where the shot had been given, where the band aid had been, everything was visible in red and was raised and itchy. Mind you, I could not see any indication of a shot or band aid mark, prior to this. The area became hot, the area underneath the redness became hard and at its worse spread to about the size of a half dollar, (slightly larger). It also became very tender.  I researched it and learned it was "Covid Arm" and that it was not serious, but should be reported. The itchiness was relieved with otc itch cream and I took ibuprofen for the pain and used an ice pack for the swelling.  The itchiness stopped on 3/14, the pain  on 3/13, the swelling was resolved by 3/15 and now there is only a very faint red area, hardly noticeable as of 3/16.
This case was reported by a consumer via call center representative and described the occurrence of fever in a 9-year-old female patient who received ENGERIX B pediatric (batch number unknown, expiry date 1st July 2015). On 1st October 2015, the patient received the 3rd dose of ENGERIX B pediatric. On 1st October 2015, an unknown time after receiving ENGERIX B pediatric, the patient experienced expired vaccine used. On 2nd October 2015, the patient experienced fever, sore throat, local swelling, influenza-like symptoms, pain, tiredness and feeling unwell. The patient was treated with TYLENOL. On an unknown date, the outcome of the fever, local swelling, influenza-like symptoms, pain, tiredness and feeling unwell were recovered/resolved and the outcome of the sore throat was not recovered/not resolved and the outcome of the expired vaccine used was unknown. The reporter considered the fever, sore throat, local swelling, influenza-like symptoms, pain and tiredness to be related to ENGERIX B pediatric. It was unknown if the reporter considered the feeling unwell to be related to ENGERIX B pediatric. Additional details provided were as follows: This case was previously reported to a doctor. This case was reported by the patient's mother. On 2nd October 2015, 1 day after receiving 3rd dose of ENGERIX B pediatric vaccine, the patient experienced flu-like symptoms, a fever of 102 degrees F, aches, pain, feeling tired, sore throat, and had felt a bump on the bottom of her cheek area. The patient also complained of not feeling well. The patient's mother gave her TYLENOL and between that day and the following day most of the patient's symptoms resolved although the sore throat continued. According to the patient's mother she received a call from the hospital that administered the vaccine and was informed that, the patient received an expired vaccine with an expiration of 1st July 2015. The patient's mother stated that she is very worried about the safety of her daughter and would like to speak to someone about this situation. She just learned of the expired dosing on the reporting day and she was frantically attempting to get information about what this may do to her daughter. The reporter did not wish to stay on the line to provide any further details and stated that if someone from safety would like to call her she would then provide additional information at that time. The patient's mother reported that she needed to call the hospital to see whether the patient should be revaccinated or if the patient needs to be hospitalized. The reporter only had limited information about the dosing and did not have the lot number. The patient's mother was requesting for correspondence as soon as possible.