chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Spotting; Bleeding; Cramping; My hips are hurting and difficult to walk; I have had multiple earaches; my fingers are inflamed in joints; I am exhausted and require more sleep than before; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VAGINAL HAEMORRHAGE (Spotting), VAGINAL HAEMORRHAGE (Bleeding), MUSCLE SPASMS (Cramping), GAIT DISTURBANCE (My hips are hurting and difficult to walk) and EAR PAIN (I have had multiple earaches) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included HYDRALAZINE, LOSARTAN, DILTIAZEM and LEVOTHYROXINE for an unknown indication.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VAGINAL HAEMORRHAGE (Spotting), VAGINAL HAEMORRHAGE (Bleeding), MUSCLE SPASMS (Cramping), GAIT DISTURBANCE (My hips are hurting and difficult to walk), EAR PAIN (I have had multiple earaches), ARTHRITIS (my fingers are inflamed in joints) and FATIGUE (I am exhausted and require more sleep than before). At the time of the report, VAGINAL HAEMORRHAGE (Spotting), VAGINAL HAEMORRHAGE (Bleeding) and MUSCLE SPASMS (Cramping) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound pelvis: normal.         No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-087078.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Follow up received
This case was reported by a consumer via call center representative and described the occurrence of fever in a 73-year-old female patient who received SHINGRIX for prophylaxis. On 12th September 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, headache, nausea, vomiting and pain in arm. On an unknown date, the outcome of the fever, headache, nausea, vomiting and pain in arm were recovered/resolved. It was unknown if the reporter considered the fever, headache, nausea, vomiting and pain in arm to be related to SHINGRIX. Additional details were reported as follows: The SHINGRIX vaccine lot number or expiry date was unknown. The caller was a patient who reported she was right around the 6 month mark for getting her second SHINGRIX. The patient stated that she experienced a low grade fever (around 100 degree Fahrenheit), headache, nausea, vomiting, and the sorest arm from any injection she had ever had. All symptoms lasted for 2 to 3 days and resolved. Lab Comments: lab test performed on an uknown date.
Initial misuse report received from a healthcare professional on 08 January 2014. A patient of unspecified demographics, whose medical history and concomitant medications were not reported, had received ACTHIB on an unspecified date. The ACTHIB was reconstituted with sterile water instead of the diluent. The patient did not experienced any adverse event. Documents held by sender: none.
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications, drug reactions and allergies were not reported. On 02-OCT-2018, the patient was vaccinated with an improperly stored dose of VARIVAX lot # R011806 and expiration date: 23-APR-2020 (strength, dose, route of administration and anatomical location were not reported) indicated for prophylaxis which was reconstituted with sterile diluent (MERCK) (product storage error). No adverse effect was reported. Administered dose of vaccine experienced a temperature excursion of -14 degrees Celsius to -10 degrees Celsius (-11.9°C) for 1 hour and 27 minutes on unspecified date called by a data logger. There were no previous excursions reported.
A report has been received from a Physician concerning a multiple patient of unknown genders, who had been receiving Nasal FLUMIST Quadrivalent started on 29-SEP-2015. The doctor reported that the FLUMIST Quadrivalent was administered to approximately 80 to 100 consumers during a temperature excursion with the vaccine between the dates of 29-SEP-2016 and 09-NOV-2015. The doctor was not able to provide the identifiable information pertaining to consumers involved in receiving the FLUMIST. The outcome of the event of administering to approximately 80 to 100  consumers during a temperature excursion with the vaccine was unknown. The report was considered to be non-serious.
Sore right arm, fever, chills, joint pain, headache, abdominal pain, vomiting. Symptoms began approximately 12 hours after injection and lasted approximately 36 hours.
on 4/09/21  around 9pm body pain all over next day same 4/12/21 about 12:15 started having muscle sprasms on left side  had them off and on all week so i started taking my medicine that time one per day call dr. he said that 15mg on4/17 rash appeared on body  next day was bad down my legs went to clinic said that was a reaction from the shot gave me cream  mometasone  1 time daily  next day all in my mouth went to ER they gave me benadryl pantoprazole 40mg,predinsone 50mg, they stated that it was medicine reaction  it was from my head to my feet in rash
Patient complained of her arm being swollen and red and warm to touch from elbow to shoulder. She also complained of fever. She also broke out in a fine rash all over her body.
Erythma Multiforma (oval bulls-eye rashes around midsection and under arms) - potential immune response to Flu Shot
I received my vaccine on a Friday and Monday I had my normal yearly blood work and that's when my doctor noticed my white blood cells were low. I had a fever, headache, chills, body aches for about 3 days and then it went away. Four months after vaccine I had my blood work re-done and they were still low.
This patient has headache, body aches, flu-like symptoms, bowel problems; patient also reports same symptoms post 4th shot 01/08/00. Diagnosed with perforated colon 4/14/2000, corrective surgery performed. Also diagnosed with fibromyalgia. Follow up:  Patient did not recover from adverse event.  Patient experiences extreme fatigue, joint aches, headahces, arthritis in spine.  Hyper allergenic, continuing intestinal problems.  Patient's current duty status is full duty, however approximately 60 days of work has been missed.  The patient has not been evaluated by a physician or health care provider for this event.  Patient did not receive any further shots since reported event."
Blood clots, high blood pressure, migraines, heart palpitations, swollen lymph nodes under arm and in left breast, heavy menstrual cycles. I have to now take a blood thinner, water pill, blood pressure pill, and migraine medicine. I have to have follow ups with hematology, rheumatology, my PCP,  my OB/GYN, and have been referred to another facility for further appointments.
covid vaccine breakthrough case  all Pfizer dose 1 12/30/20  EL0140 dose 2 1/21/21  EL3249
Mother informed the nurse that pt started trembling like a seizure and looked like she was trying to cheew her tongue and got pale. Approximately 4 hrs post receiving vaccines, temp 101.3 deg F, at that time mother and father took pt to urgent care and was seen by MD. Was told pt was allergic to something in the DTaP and not to get that vaccine again. Mom wsa told to give pt Tylenol and no meds given at ER.
41 year old male who reported no problems with his health or prior immunizations until re received the typhoid vaccine on Sat, 5 Feb 2005. He fulfilled his requirements for his drill weekend, although he noted a "wicked" headache on Sun that eased and subsided by Wednesday. He also noted a low grade fever. He did not note any arm soreness or redness and attributed the headache and fever as a normal response to the vaccination. On Sat 12 Feb he noticed dysmetria of his left lower extremity and symptoms worsened to include his left arm. On Mon he sought medical care and reports a positive neuro exam to included decrease sensation, problems with balance and increase reflexes. A MRI revealed 2 small plaques. He was started on steroids and reports a full recovery of all neuro functions by week #3. Subsequent MRI's did not identify any further lesions and he stated he remains asymptomatic. He is however, continuing interferon treatments. He stated he was evaluated at a clinic and they told him that they suspected ADEM and that an evaluation is thinking early MS. He stated he had received oral typhoid in the past with no problems and that he has not received any vaccines since Feb 05. Head pain start: 02/06/2005 End: 02/08/2005, Gait Abnormal Start: 02/12/2005 End: 03/2005, Weakness Start: 02/13/2005 End: 03/2005. Left arm.  04/12/2007 MR received for a single OV of 6/27/2005 for c/o fever, chills, myalgias, and headache which began w/in a few days of receiving his typhoid vax.  Several days later he c/o developing weakness and dysmetria.  Pt. reports that initial PE showed some dysmetria, of upper left  and lower limbs, as well as some clonus and imbalance.  Txd with solumedrol with improvement of physical symptoms.  However some word-finding difficulty remained.  PE: WNL with minimal weakness in the left interossei and ankle dorsiflexors and muslce stretch reflexes are mildly brisk.  Impression:  Clinically isolated CNS inflammatory/demyelinating syndrome, post-vaccination.  Avonex therapy.  04/19/2007 MR received from MS clinic with several OVs from 9/19/2005 to 10/30/2006.  Also included were H&P and D/C Summary from initial hopitalization for AE in 2/2005. H&P dated 02/14/2005 for c/o incoordination, ataxia, and myoclonic jerks x 36 hours.  Myoclonic jerking was noted in the L leg and L arm with associated arm heaviness.   PE showed myoclonic jerking with purposeful movement of the LLE. Biceps DTR 1+.  3+ in quadriceps and  Achilles with myoclonus on the Left. Wavers with Rhomberg, but able to correct self. Wide-based unsteady gait.Slow finger-to-nose on left. Decreased vibratory sensation left foot, otherwise WNL. D/C next day.  DX: MS. F/Us with DX of RRMS. Tx'd with Avonex. No new codes. 04/23/2007 MR received from military facility for 2 OV dated 12/13/2006 and 12/14/2006 for c/o adverse rxn. to Typhoid vax given 2/2005. HPI as above with initial findings suggesting possible MS.  Neurology consult with normal findings. Final DX:  Clinically isolated demyelinating event.
Case number PHEH2014US010194, is an initial spontaneous report received from a nurse on 16 May 2014. This report refers to 54 year old male patient. His medical history and concomitant medication was not reported. He was vaccinated with FLUVIRIN (batch number: 1206901) intramuscular on 13 Jan 2013. Physician reported that he has erythromelalgia on an unknown date post vaccination. Rheumatologist wrote in chart "immunological phenomenon". The patient had the symptoms of pain in shins, flushing hands and feet, burning pain on both the legs, hand and both ears with erythema and swelling with any exercise including walking and swimming or any exercise from Feb 2014. The symptoms continued as of 02 May 2014. He will be having an evaluation from a neurologist. Treatment medications included NEURONTIN, ATIVAN and CYMBALTA. Outcome of the events, seriousness and causality assessment was not reported. No further information was provided.
This spontaneous report as received from a pharmacist via company representative refers to multiple individual patients of unknown demographics. No concurrent conditions or medical history were provided. On unknown dates, those patients were vaccinated with doses of ZOSTAVAX injection (strength, dose, route of administration, lot# and expiry date unspecified). No concomitant medications were reported. The pharmacist reported that an anonymous individual heard of a physician who had seen that multiple individual patients got the shingles after getting ZOSTAVAX. The outcome of shingles was unknown. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
This spontaneous report as received from a other health professional refers to a 15 year old patient. On an unknown date the patient was vaccinated with VAQTA, 1 milliliter for prophylaxis. On an unknown date the patient experienced incorrect dose administered and no adverse event. The outcome of incorrect dose administered and no adverse event is unknown. The reporter considered incorrect dose administered and no adverse event to be not assessed to VAQTA.
Injection site induration 2.5 by 2.5 inches; patient complained of pain at site. Monitored vitals. Gave 25mg Benedryl.
This spontaneous report was received from a registered nurse regarding a patient of unknown age. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 20-FEB-2019, the patient was vaccinated with improperly stored ROTATEQ (lot # R025732, expiry date: 25-MAR-2020) for prophylaxis (Product storage error). Temperature and time frame of temperature excursion was noted as from 29-JAN-2019 (12 Degree Celsius for 1 hour 21 minutes) to 26-FEB-2019 (10 Degree Celsius for 22 minutes). It was reported that there were no previous temperature excursions. Digital data logger was noted as Yes. No adverse events were reported (no adverse event). The outcome of product storage error and no adverse event was unknown. This was five of nine reports mentioned in the report. Sender's Comments: US-009507513-1903USA009054:Master case.
I?m not sure if it was a rash or hives that started on my left arm and spread all the way across my chest. The lymph node under my left arm was the size of a small golf ball for five days. I had a headache for 12 days.
Very Dry Eyes, predominantly the right eye. Blurry vision in right eye that hasn't fully come back into focus although seems to be better each day.
No adverse effects; an adult patient was administered the pediatric strength of VAQTA; an adult patient was administered the pediatric strength of VAQTA; This spontaneous report has been received from a medical assistant referring to an adult patient of unknown age and gender. No information on patient's pertinent medical history, concomitant medications, drug reaction or allergies was provided.  On 09-SEP-2019, the adult patient was administered the pediatric strength of hepatitis A Vaccine, Inactivated (VAQTA) one shot (route not reported, lot # S005725, expiration date: 10-JUL-2020) for prophylaxis (product administered to patient of inappropriate age, incorrect dose administered). No adverse effects were reported.
Tested positive for covid; Tested positive for covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 12 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 03Jun2021 (Lot number: EW0185) at the age of 12 years as dose 2, single and administration date 13May2021 (Lot number: EW0168) as dose 1, single for covid-19 immunisation. Relevant medical history included: "ADHD" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: VYVANSE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06Feb2022 21:30, outcome "recovering" and all described as "Tested positive for covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (04Feb2022) negative, notes: Nasal Swab; (06Feb2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.
After receiving the 2nd vaccine, I had pain in my left shoulder which I thought was normal . However , it has been 6 months and the pain has not subsided. I am awakened at night with severe shoulder pain. I have had pain and weakness in my left shoulder despite taking Aleve and Aspirin. I used to enjoy lifting weights, but have been unable to do so since the second shot.
Extreme tiredness; Headaches; Dizziness; This is a spontaneous report from a contactable patient. A 67-year-old non-pregnant female patient received the 2nd Dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot/Batch no: EN6208) solution for injection on her left arm via an unspecified route of administration for Covid 19 immunisation on 12Mar2021 at 12:30 PM. The patient had a medical history of heart issue (past heart attack on an unknown date in 2017 and was on medication) and Colitis. On 19Feb2021 at 10.30 am the patient received her first dose of BNT162B2(BNT162B2) (lot/Batch no: EN6203) solution for injection on her left arm via an unspecified route of administration for Covid-19 immunisation. The patient has not had symptoms associated with COVID-19 and was not tested for covid-19 prior and post vaccination. On 12Mar2021 at 18:30, the patient had experienced extreme tiredness, headaches and dizziness. No therapeutic measures were taken for the reported events. The patient had not recovered from these events at the time of this report. No follow up attempts are needed. No further information is expected.
Loss of mental faculties and constantly lost confused  Excessive sleep.  Fatigue vomiting and nausea
Within 5 minutes I had burning and throbbing elbow in the injected arm?s elbow (left). Throughout the day I then experiences pain and swelling at the injection site and I cousins lift my arm for 24-48 hours due to joint pain in my shoulder. By night time around 8:00 PM I was extremely fatigued and it is now 5 days later and I am experiencing worse joint pain, fatigue, and now running a fever 5 days later around 100.7
Nausea started first then a head ache and chills shortly afterwards along with body aches and general discomfort. After taking 3 ibuprofen (200mg ea) and a half hour later my temperature was 101.7 (9 pm)  and the headache never went away. I continued with Ibuprofen every 4 hours which helped temperature but not very strong headache.  The nausea subsided by 11 pm. The next morning (today) my temperature is 100.3 without any ibuprofen but fatigue and body aches remain. I have not contacted my doctor yet but will sent a note through patient portal. ( I checked off Doctor visit on Item 21 because I had to enter something. )
It began on 2/3/2021 to present low saturation, pressures rose and fell (unstable). They gave him therapy, since he could not breathe. On 02/04/2021, POC reports that caregivers took their rounds and he was without vital signs. Doctor certifies that it was due to respiratory failure.
Weakness; Hot; Felt Sick; Shaky; Headahces; Vomited; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), FEELING HOT (Hot), ILLNESS (Felt Sick), NERVOUSNESS (Shaky) and HEADACHE (Headahces) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hashimoto's disease, Penicillin allergy, Gluten intolerance, Drug allergy (sulpha drugs) and Adhesive tape allergy (Allergic to bandage adhesive).   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 26-Feb-2021, the patient experienced ASTHENIA (Weakness), FEELING HOT (Hot), ILLNESS (Felt Sick), NERVOUSNESS (Shaky), HEADACHE (Headahces) and VOMITING (Vomited). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 27-Feb-2021, ASTHENIA (Weakness), FEELING HOT (Hot), ILLNESS (Felt Sick), NERVOUSNESS (Shaky) and VOMITING (Vomited) had resolved. On 03-Mar-2021, HEADACHE (Headahces) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications was taken for Hashimoto's disease.  Treatment details included Tylenol and patient was also drinking plenty of water to alleviate the events she was experiencing.   This case was linked to MOD-2021-117740 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Additional information received and does not contain any new information On 20-Jul-2021: Additional Information received included no new Significant  information, allergies were added. On 20-Jul-2021: Additional information received  and does not contain any new information
The swelling seems to be worsening just to the point where I look unnatural.; I noticed my lips seemed extra full; The swelling seems to be worsening; This is a spontaneous report from a contactable consumer (patient). A 48-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN5918), via an unspecified route on 10Feb2021 at 11:15 (at the age of 48-years) as dose 2, single in the left arm for covid-19 immunisation. The patient medical history included mild hypertension, arthritis from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient had no known allergies. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL8982), via an unspecified route on 20Jan2021 at 01:00 as dose 1, single in the left arm for covid-19 immunisation and received Juvederm in her cheeks and lips since Oct2020. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, it was unknown the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 17Feb2021 at 05:00, the patient experienced swelling seems to be worsening just to the point where she look unnatural. Patient stated that with the fact that she had facial fillers. She believe Juvederm. Have had it in her cheeks and lips since Oct2020. One week after her second dose, she noticed her lips seemed extra full. She did not think anything of it but then remembered that the person who did facial fillers mentioned there were some reported issues after vaccine. The swelling seems to be worsening just to the point where she look unnatural. She plan to contact her healthcare provider tomorrow to see about steroids or something else to hopefully remedy this situation.The patient did not receive treatment for events. The outcome of the events was unknown.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
About 20 minutes after giving injection, patient came back dizzy, then fainted. I called 911, then gave her an Epi Pen shot in thigh, which revived her, then the ambulance came.
Pt received Moderna Covid vaccine on 3/24/2021 and then received Pfizer Covid vaccine on 4/21/21.  This was 4 weeks apart but the same vaccine was not given for the second dose.
PT TO ED WITH C.O CHEST PAIN X 4 DAYS, Reports cough. Pt on 3L NC, satting at 94%.
Temp increased 104 degrees F on 4/10/11, 2300. Treated with TYLENOL, temp decreased 102 degrees F.
Patient presented with vertigo, mild chest pain. In the ED, CK elevated in the 20,000s , troponin within normal limits, CKMB borderline elevated. EKG and echocardiogram were not concerning, cardiology stated low suspicion for myocarditis. Chest pain resolved by time of admission, vertigo and elevated CK improving with D5 Normal saline at 1.25x maintenance.