chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient had a blotchy rash on his whole torso; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Patient had a blotchy rash on his whole torso) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced RASH MACULAR (Patient had a blotchy rash on his whole torso). At the time of the report, RASH MACULAR (Patient had a blotchy rash on his whole torso) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient describes local soreness to left arm. Swelling and redness in a 3 inch by 2 inch diameter around the sire. Achiness overall and limited ROM due to sore left arm. She deferred an office visit but was given signs and symptoms of anaphylactic reaction.
Around midnight I began to feel severe sysmtoms around my ark sight beyond soreness. I fell like my arm was having a constant spasm near the injection site. Eventually I began to have full body spasms that were minor, however in no way controllable. My feet were randomly kicking (tiny little spasms) and my right arm, as well as my left arm and a few times my fingers. I felt extreme joint pain from fine motor. I was rolling play-doh in my hands and began to feel mild discomfort in all joints being used to play with play doh ie. My wrist and fingers. My arm is extremly sore to the point where holding it up is a challenge. I went to sleep as spams got worse. I woke up around 3 am and the spasms had quit however an intense cold sensation remains near injection site. My temperature is 96.5. Ive had a heating pad on my injection site on and off for last 6 hours which did help with the cooling sensation
A day after receiving the immunization, the patient got a fever and felt like she had the flu.
Right arm red swollen slightly tender and small area and induration. Erythema 6" x 4"
I received my 2nd booster shot on 04/18/2022 and my COVID symptoms started on 05/10/2022 some time in the evening scratchy throat, 05/11/2022 I woke up at 01:30 PM felt fever and achy all over my body. Wednesday and Thursday I stayed in bed all day. I did a home COVID test on the Wednesday 11th and it was negative. 05/10/2022 my wife was positive. But I was negative. The guest that came in my apartment was COVID positive, so were all positive. I messaged my doctor and she sent medications for me and my wife. PAXLOID for 5 days starting on the 05/13/2022. My wife tested positive on 05/12/2022.
got the shots, got shingles/suspected vaccination failure; got mild case of shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got the shots, but got mild case of shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. No contact details were available.
24 hours after booster shot was administered, lymph node in the left underarm got swollen
10/10 pain in right knee/spread to thigh and buttocks area; 10/10 pain in right knee/spread to thigh and buttocks area; spread to thigh and buttocks area/ pain has gotten slightly better in right leg; This is a spontaneous report from a non-contactable consumer via Pfizer. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that after the first injection of the Pfizer covid vaccine, patient had 10/10 pain in right knee. Two days later pain was still 10 and had spread to thigh and buttocks area. The patient went to urgent care and was given pain meds. Pain was slightly better in right leg about a 7-8. Events took place after use of product. He was due for second injection on 18Mar2021. He had appointment with orthopaedic on 22Mar2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Syncopal episode, diaphoresis & paresthesias are reported in pt who recvd flu vax; w/in 45 mins of vax, pt exp brief syncopal episode followed by diaphoresis & paresthesias; pt taken to ER;
This spontaneous report was received from a medical assistant referring to unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates (reported as from 06-DEC-2016 to 04-JAN-2017), the patients underwent the administration of improperly stored doses of GARDASIL 9 with lot numbers L040054 and M024261; and expiration dates 26-DEC-2017 and 30-JUL-2018 respectively (dose and route of administration were not provided) for prophylaxis. There was no adverse events reported. Administered doses of GARDASIL 9 were exposed to a temperature excursion of 35°F for 60 hours. Data logger was not involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA007868: US-009507513-1701USA007870: US-009507513-1701USA007871: US-009507513-1701USA003063.
Fatigue, muscle aches, slight chills, most significant side effect -- moderate to severe pain along spinal column (day 1 and 2).
Case number PHEH2014US025039, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 32-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 31 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event reported following this medication error.
Swelling in right axillary region...fever 100-101 for 2 days... fatigue... body aches
Information has been received from a nurse referring to unspecified patients of unknown age and gender. Since an unspecified date in May 2015, the patients had been administered improperly stored doses of ROTATEQ (lot number L004453, expiration date 27-MAY-2016, dose was unknown) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Developed red rash just below injection site two days after vaccine, second dose. Per current side effect information, this can occur after the first dose, not the second. Rash is currently ongoing.
pt recvd vax & woke up felt real warm-mom gave some more APAP; pt was thirsty & asked for water; pt went back to sleep; pt was fretful; real stiff-legs stiff, eyes looked funny & white stiff & was coming out of mouth;
A non-serious spontaneous report of administration of expired product was received from a nurse practitioner concerning a four year-old male, which occurred after receiving expired FLUMIST.  There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Based on the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the Flu season resulting in some medication errors that occurred shortly after the product expired. Follow up information was received on 06-Mar-2009 and incorporated into the narrative: confirmed that there were no adverse events associated with the medication error. Additional information was received on 09-Apr-2009: product complaint investigation results.
Patient reported feeling anxious, and dry heaving, also appeared diaphoretic Patient provided water and seen by medical team Patient refused medical transport and signed AMA form Patient stated symptoms resolved and will be driven home by spouse
Mom went to get him when woken from nap by barking dog and thought he looked purplish in the face. He seemed drowsy, like he wanted to fall asleep as she carried him to answer the door. Neighbor commented on how flushed he looked. Mom splashed some water on him, took his temp. On her thermometer was 97 deg. Checked on neighors' thermometer was same.  Mom gave 3 mL of Tylenol. Called and requested appointment.  In the car to appointment was alert. In clinic, at 6:30 PM found to be quite flushed head to toe, blanching, but otherwise normal exam. Normal heart rate (126) O2 sat (96%). Temp elevated at 100.2 deg F, rectally. Remainder of exam normal: No edema to lips or tongue. No wheezing or respiratory distress. Gave 12.5 mg of PO diphenhydramine in clinic.
10 to 12 hours after her second Moderna Covid-19 vaccine achiness; 10 to 12 hours after her second Moderna Covid-19 vaccine low grade fever; 10 to 12 hours after her second Moderna Covid-19 vaccine chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (10 to 12 hours after her second Moderna Covid-19 vaccine achiness), PYREXIA (10 to 12 hours after her second Moderna Covid-19 vaccine low grade fever) and CHILLS (10 to 12 hours after her second Moderna Covid-19 vaccine chills) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 032L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced PAIN (10 to 12 hours after her second Moderna Covid-19 vaccine achiness), PYREXIA (10 to 12 hours after her second Moderna Covid-19 vaccine low grade fever) and CHILLS (10 to 12 hours after her second Moderna Covid-19 vaccine chills). At the time of the report, PAIN (10 to 12 hours after her second Moderna Covid-19 vaccine achiness), PYREXIA (10 to 12 hours after her second Moderna Covid-19 vaccine low grade fever) and CHILLS (10 to 12 hours after her second Moderna Covid-19 vaccine chills) outcome was unknown.            No concomitant medication was provided by the reporter.  No treatment medication was provided by the reporter.   Reporter did not allow further contact
Donor c/o diarrhea for two days, stating the day after he received immunization.
Brain Fog; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: Mar2021, for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), administration date: Apr2021, for COVID-19 Immunization. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "Brain Fog". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
10mins post vaccination pt reported swelling & tickling throat. MD at bedside @11:27 Vitals: 11:30 156/113, 104, 22 and pt feels anxiety -- > 1131 157/123, 94, 22, O2 100% -- > 1139 199/142, 120, 22, 100% -- > 11:46 161/123, 102, 20, 100% 1129-Pt wearing 2 masks-one mask removed, Lung sounds normal per MD with no signs of wheezing.   11:37 Pt c/o numb tongue-RN administered 0.3mg of epi. Left outer thigh r/t reaction from Pfizer dose #3. Pt tolerated med admin well.  Pt remains alert and oriented.  1138 911 called for transport/eval.  1139 Pt talking and laughing.  1145-Pt remains talking and oriented. States tongue "feels so much better:" Pt shaky. Reassurance to pt this is from epi.  1148-Paramedics arrived. Pt stable.Pt states her throat feels dry, tongue swollen Pt taken to the ED ~12:00  In the ED: 45-year-old female with a history of allergic reaction to tree nuts coming in now by ambulance from her vaccination clinic where she had a scheduled appointment for COVID-19 booster shot.  20 minutes after getting the booster shots she developed sensation of tongue swelling and tingling.  However she reports that lips and tongue and mouth did not look swollen.  She was immediately given an epi shot and it quickly resolved all of her symptoms.  The shot was given at 11:30 AM by her doctor.  No other medications were given.  She has no symptoms at all at this time.  Symptoms were mild nonradiating described as possible anxiety or allergic reaction.  She denies any ingestion of substances with tree nuts.  Did not have any reaction to any Covid 19 vaccinations in the past. No worsening factors were reported.  Symptoms were not associate with any rash, trouble breathing or swallowing or speaking or drooling shortness of breath or cough or wheezing abdominal pain passing out syncope lightheadedness or other complaints at all. Pt observed for several hours and given methylprednisolone 125mg IV x1 and diphenhydramine 50mg IV x1. Pt d/c'd in stable condition with RX for Epi 0.3mg Auto-injector, Famotidine 20mg BID x5days, diphenhydramine 25mg PO Q6hrs PRN Itching, and Prednisone 20mg PO Daily x 4 days.
Stinging pain on or in tongue.  Treated by multiple physicians with oral visualization to determine if there is anything to see - the results of visual exam are normal.  The pain is on one spot on the tongue and does not go away, however it seems worse as the day goes on.  The pain has persisted since March 20 and is still a problem.
I developed C-dif during the time between my second and third shot, not sure if it was related to the vaccine.
Information has been received from a nurse concerning a 35 year old female who on 13-DEC-2000 was vaccinated with Hepatitis B vaccine recombinant (yeast) in her right deltoid  (lot number not in patient's chart). There were no illness at the time of vaccination. Approximately three weeks after her second dose, in December 2000, the patient developed mild jaundice, orange urine and fatigue. The patient visited her physician. Lab work (unspecified) and an ultrasound were performed. The ultrasound did not show any significant findings. As of 12-Mar-2001, the patient was undergoing tests to determine if her condition was related to her gallbladder. The reporting nurse also stated that the physician did not believe the patient symptoms were related to the Hepatitis B vaccine recombinant (yeast). Additional information is not expected.
At the time of Flu injection I felt extreme pain and what felt like the medicine going into muscle.  I received a Tetanus shot and a Hep A shot as well in a different arm that felt nothing like this.  After the injection the pain remained the same and is still the same on day 3.  I also have limited range of motion in arm.
Information was received on 24-APR-2017 from a lawyer regarding a case in litigation concerning a female of unknown age. On 13-MAR-2015 the patient received a dose of ZOSTAVAX for its intender purpose: the prevention of shingles. On 30-MAR-2015 the patient went to the hospital with complaints of lower extremity pain and symptoms of paresthesias. The patient was admitted to the hospital. A neurological work-up showed cervical spinal stenosis and large posterior disc herniation. Lumbar puncture was performed and the results, along with her symptoms, led to a diagnosis of Guillain-Barre plus Syndrome. The patient's Guillain-Barre plus Syndrome was caused by the ZOSTAVAX vaccine. The patient was hospitalized until 09-APR-2015. The patient subsequently went to a rehabilitation hospital for approximately two weeks and underwent outpatient rehabilitation. The patient suffered nerve damage and continues to suffer from loss of balance and leg pain. As a direct and proximate result of the defective ZOSTAVAX vaccine, the patient continues to experience ongoing symptoms, including imbalance and leg pain. The patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of manufacture, marketing, advertising, promotion, distribution and/or sale of ZOSTAVAX, the patient suffered severe and permanent injures. Further, as a tragic consequence, the patient suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has incurred and will continue to occur medical expenses and other economic harm as a direct result of use of ZOSTAVAX. As a direct and proximate consequence of negligence, the patient sustained serious personal injuries and related losses including but not limited to the following: The patient required and will continue to require healthcare and services; the patient incurred and will continue to incur medical and related expense; and the patient has suffered, and will continue to suffer mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life and other losses and damages. Upon internal review, Guillain-Barre syndrome and cervical spinal stenosis were considered medically significant. Guillain-Barre syndrome was considered disabling. Additional information has been requested.
The next morning the patient had experienced cramping in the stomach, severe nausea, and vomiting. The abdominal cramps lasted for 2 days...
Got shingles 2 months after my second shingles shot/Suspected vaccination failure; Got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, 2 months after receiving Shingles vaccine and unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got shingles 2 months after second shingles shot. The vaccination didn't work for the patient. This case was considered as suspected vaccination failure as details regarding laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
After receiving the HPV vaccine patient fainted, fell and loss consciousness for about 10 seconds.
Migraine headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine headache) and CHILLS (Chills) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included High cholesterol. Concomitant products included ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL, SALICYLAMIDE (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL;SALICYLAMIDE]) and ATORVASTATIN for an unknown indication.    On 28-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced MIGRAINE (Migraine headache) and CHILLS (Chills). At the time of the report, MIGRAINE (Migraine headache) and CHILLS (Chills) outcome was unknown.        No treatment information was provided.
This spontaneous report as received from a nurse practitioner refers to a female medical assistant of unknown age who on an unknown date, received a 3 dose series of RECOMBIVAX HB (doses, routes and lot numbers not reported) and had negative titers for hepatitis B. At the time of the report, the patient's outcome was unknown. The relatedness for negative titers for hepatitis B and RECOMBIVAX HB was unknown. Additional information has been requested.
This non-serious spontaneous case, initially received from other non-health professional on 14-Nov-2018, concerning a female patient of an unspecified age. On an unspecified date, the FLUCELVAX QIVc vaccine underwent first temperature excursion with maximum temperature (Tmax) 8.2 degree Celsius for 4 minutes. On 22-Oct-2018, vaccine underwent second temperature excursion with Tmax 9.8 degree Celsius for 23 minutes. On an unspecified date, two temperature excursions were identified after an audit. On 29-Oct-2018, the patient was inadvertently administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration, anatomical location: left deltoid, batch number: 252672 and expiry date: 30-Jun-2019) which underwent temperature excursion. The patient did not experience any adverse effect after the vaccination. This case is linked to 201805262 (same reporter).