chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received the Janssen vaccine on 3/17/21 at 4:42 pm. Beginning at 2:30 am on 3/18/21 the patient began to experience dizziness, vertigo, shaking, tremors, nausea, and vomiting. The shaking and tremors occurs all over but is most significant in the hands and arms leaving the patient unable to do simple daily tasks or return to work.  These symptoms began 3/17 and have persisted every day since in varying severity. Sometimes the tremors last for more than 20 minutes straight. The patient was seen in the emergency department on 3/26/21 but the hospital notes are unavailable to the pharmacy at this time. Per patient, he had an MRI and no other tests and was given a prescription for ondansetron for nausea and discharged. The patient believes he was not adequately assessed and is still suffering from symptoms. He has a follow up with a primary physician 5/28/21 which is the soonest he was able to be referred.
migraine; significant itchiness; bumpiness on skin; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (significant itchiness), MASS (bumpiness on skin) and MIGRAINE (migraine) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     Concurrent medical conditions included Brain tumor and Depression. Concomitant products included TAMSULOSINE [TAMSULOSIN], ATORVASTATIN, SERTRALINE, FISH OIL (OMEGA 3 FISH OIL [FISH OIL]), VITAMIN D3 and PARACETAMOL (TYLENOL) for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 27-Apr-2021, the patient experienced PRURITUS (significant itchiness) and MASS (bumpiness on skin). On an unknown date, the patient experienced MIGRAINE (migraine). At the time of the report, PRURITUS (significant itchiness), MASS (bumpiness on skin) and MIGRAINE (migraine) had not resolved. Unknown          Concomitant medications also included riveltectim (sic). Action taken with mRNA-1273 in response to the event was not applicable   This case was linked to MOD-2021-101599 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: NNI
pt recv vax 19MAR97 & approx 24hr p/vax pt devel a dry cough, then 24hr p/vax devel cold sx;then in another 24hr devel breathing diff & wheezing that required tx @ urgent care;treated both times w/breathing machine;
Within a few minutes after the vaccination in the Post Vaccine Observation area the patient reported chills, nausea, headache, itching, and "feeling like I'm dreaming".  Patient also had an elevated systolic blood pressure.  Diphenhydramine 25mg PO was given and the patient was transported to the emergency department via wheelchair.  Patient was observed in the emergency department and discharged home.
Vaccine administered to female age 17 years, 4 months old.  Parental consent of file.
auditory hallucinations; Initial extreme fatigue; weakness; worsening tinnitus; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: not reported), via an unspecified route of administration in the left arm on 15Apr2021 at 14:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to cashews and pine nuts; back pain associated with herniated discs, major recurrent depression severe, generalized anxiety disorder. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), lamotrigine (LAMICTAL), calcium levomefolate (DEPLIN), acetylsalicylic acid (ASPRIN), celecoxib (CELEBREX). There were no other vaccinations within four weeks of the vaccine. On 16Apr2021 at 23:45, the patient experienced initial extreme fatigue and weakness which had been replaced by auditory hallucinations and worsening tinnitus. It was unknown if the patient was treated for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of initial extreme fatigue, weakness, auditory hallucinations, and worsening tinnitus was not resolved.  Information on the Batch/Lot number has been requested.
Itch on arm at site 8 days after injection. Growing Redness around site that was warm To touch.  No pain.    Applied cortisone cream- this helped for the day but started to worsen after 7 hours.  Size of redness was about That of a baseball.  Still warm.  Redness and warmth  dissipated on 1/23 without further cortisone.   I was concerned about cellulitis so I monitored symptoms.
This spontaneous report was received from a pharmacist refers to a currently 40 years old female patient. The patient did not have any concomitant medication, drug reactions or allergies. The patient's historical drug included vaccination with a measles, mumps, and rubella vaccine (manufacturer unknown) as an infant. On an unknown date (reported as: "a few years ago"), the patient was vaccinated with M-M-R II (dose, route of administration, lot # and expiry date were not reported). On an unknown date (reported as: "a few weeks ago), the patient showed a low titer for Rubella. The outcome of the event was not reported. The causality assessment was not reported.
Second dose is due for more than 42 days; Fever (it wasn't documented); This spontaneous case was reported by a physician and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose is due for more than 42 days) and PYREXIA (Fever (it wasn't documented)) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose is due for more than 42 days) and PYREXIA (Fever (it wasn't documented)). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose is due for more than 42 days) had resolved and PYREXIA (Fever (it wasn't documented)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Sep-2021: Follow up received on 27 Sep 2021 contains no new information.
At 6pm the same day as the vaccine I started feeling tired and went to bed early (8pm).  The next day when I woke up I had a low fever, chills and typical flu symptoms.  My skin was sensitive to the touch and I was extremely fatigued.  I only got up to eat and use the bathroom.  I experienced these symptoms for the next 3.4 days and took tylenol and ibuproben to reduce the effects.  I felt ok for one day (Thursday).  The next day (Friday) my throat felt scratchy in the morning and was worse in the evening.  Saturday (one week post vaccination) when I woke up my throat hurt extremely bad and I could hardly swallow.  I went to urgent care, was diagnosed with strep and started on antibiotics (Amoxicillin). I basically slept for the next few days (Sat to Tues) again only getting up to eat/use bathroom, as I was extremely tired.  By the next day (Wed) my throat cleared up for the most part and I was able to return to work, although I was still feeling fatigued and was in bed early by 8:30 or 9pm.  By Friday I was able to work a full day, but was extremely tired at the end of the day and going to bed early still.  That weekend (2 weeks post vaccination), I started feeling tired mid day and needed short naps on Saturday and Sunday.  On Monday I had to leave work early as I began feeling fatigued around noon.  I came home and rested and went to bed early.  On Tuesday I was extremely fatigued by 11am and came home to take a nap.  This has pretty much been my life since then (now a little over 4 weeks post vaccination).  I am tired all the time.  I wake up around 7am most days - I have a 3 year old child and I get him ready for school.  I drop him off and go to work, but by 11am I feel extremely fatigued to the extent that I cannot concentrate at all and I have to return home.  Maybe it is what they call "brain fog", but it is associated with extreme fatigue.  I come home and nap for between 1-3 hours, but I do not feel rested and it is generally still hard for me to concentrate.  I go to bed early around 8:30pm.  Sometimes i wake up during the night, but most nights I sleep without waking.  Some mornings I feel ok when I wake up, but most of the time I do not feel well rested.  This is really having an adverse effect on my work, and also on my mental health (because I cannot do my job effectively and I am generally too tired and grouchy to enjoy the evenings with my family).  I just feel exhausted all the time even though I have been sleeping 13-16 hours per day.  I visited my doctor 3 weeks post vaccination and described this situation.  He ordered blood work which showed everything was within normal ranges (ie; no mononucleosis, no anemia, no diabetes, no thyroid issues, no autoimmune indicators (basic panel)) - nothing out of the ordinary.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2007, the patient was inoculated with ZOSTAVAX by a physician at the physician's office as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2010, the patient was treated by the same physician for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Patient was given a High Dose vaccine when they were under 65 years of age. Patient saw no adverse reactions from the vaccine. It was given by the vaccinating pharmacist at the clinic and reported when the pharmacy manager received all the documentation was received at the store.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, in Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 31Oct2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 29 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "PCOS" (unspecified if ongoing); "IBS" (unspecified if ongoing); "long standing anxiety disorder" (unspecified if ongoing); "Sulfa based medications" (unspecified if ongoing); "depression" (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT taken for depression, start date: Aug2019; FIBER; PROBIOTICS. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of covid-19. Additional information: Paxlovid (Lot number- FX2740) Antiviral medication in 2weeks for COVID 19 Treatment from 22Apr2022 to 24Apr2022   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
In the two to three days following my 2nd dose, I had some chest pain and palpitations. This resolved on its own. Both occurrences happened at night. I had a severe headache, which also hurt behind my eyes. Six days after my 2nd dose, my headache remained (began the evening I got the injection).  I reported my symptoms on day six at a clinic. There, I was given an anti-inflammatory injection, which gave me some relief from the head ache. The chest pain resolved by then. I experienced some dizziness as well. It also resolved on its own. I don't recall how long it lasted.
2 hrs cont crying p/1st DTP/OPV on 13NOV90; 6 hrs of continuous crying was unconsolable & occassionally high pitched p/2nd DTP/OPV & 1st HIB on 15JAN91; Temp reached 101(r); Inject site hot, red, swollen; Swelling extended below knee;
DIZZINESS, NAUSEA, HEADCHES, BODYACHES, CHILLS, JOINT PAIN
62 yr old gentleman admitted with COVID-19; vaccinated March 17, 2021 Symptom onset 3/26, date positive test 4/1, started dexamethasone 4/4 and Tocilizumab 4/4. h/o DM tyle 2, htn, chronic CH, got, osa
Pt. states that after receiving the 1st dose of Pfizer 08/14/2021, started experiencing symptoms 08/14/2021 of pain in the left side of body, fatigued, and nausea.  Urgent Care visit 08/21/2021 continuing pain, Blood Work showing Liver Enzymes High. Still continuing to experience symptoms.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. On an unknown date those patients were vaccinated with 10 doses of LIQUID PEDVAXHIB (dose, units, route of administration, anatomical location, lot number were not reported) which had been improperly stored. No adverse effects reported. Follow up information was received from the medical assistant which reported that the LIQUID PEDVAXHIB (Batch No. K002818,. exp. 10-DEC-2016) affected by temperature excursion were been administered to a pediatric population of 2 month old patients. The reporter stated that approximately 15 doses (previously reported as "10 doses") of LIQUID PEDVAXHIB were administered. This is one of several report from the same source. Additional information has been requested.
red rash at injection site that grew over the course of two days and was hot to the touch, treated with Cephalexin 500 mg after visit to urgent care
Noted fever to 101 degrees F.  Chest pain, stomach ache with vomitting.  Went to ER and received IV fluids and medications for nausea and pain.  Sent back to ER two days later by FMD due to head and neck pain and lumbar puncture done, patient reports exam was normal.  Patient has improved since but still notes head congestion and cough at night.  Notes mattering of both eyes starting 9/27.  Seen in clinic on 9/28 found to have bilateral conjuctivitis.  Sulfair ophthalmic solution, 2 gtts each eye Q4 hours for 5 days given to patient.
First dose of rotavirus vaccine given at age 8 mos. No adverse reaction occurred, none anticipated.
onset of cold like symptoms including cough, congestion, sneezing, runny nose, scratchy throat. Experienced these sx for 6 days and then they resolved.
vaccine that underwent temperature excursions could have been administered to patient; No adverse event; vaccine that underwent temperature excursions could have been administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (vaccine that underwent temperature excursions could have been administered to patient), PRODUCT TEMPERATURE EXCURSION ISSUE (vaccine that underwent temperature excursions could have been administered to patient) and NO ADVERSE EVENT (No adverse event) in a 67-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     It was unknown if patient had ever been diagnosed or tested positive for COVID-19.     On 21-Sep-2022 at 6:09 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 21-Sep-2022 at 6:09 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (vaccine that underwent temperature excursions could have been administered to patient). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (vaccine that underwent temperature excursions could have been administered to patient) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (vaccine that underwent temperature excursions could have been administered to patient), PRODUCT TEMPERATURE EXCURSION ISSUE (vaccine that underwent temperature excursions could have been administered to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (vaccine that underwent temperature excursions could have been administered to patient) and PRODUCT TEMPERATURE EXCURSION ISSUE (vaccine that underwent temperature excursions could have been administered to patient).    Patient received vaccine in deltoid.  No concomitant product reported by the reporter.  It was reported that refrigeration excursions identified, state vaccine was housed in these units. There were excursions noted. Manufactures were notified and the state department and made aware of the situation. The Nurse called for a clinic that she was assisting. The clinic had a similar issue with vaccines stored in their freezer. Vaccines stored in the refrigerator that underwent several temperature excursions going back to August 2022. No adverse reactions reported for the patient. Date vial moved from freezer to refrigerator was 07 Sep 2022. The vial underwent temperature excursion.  No treatment medication reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-669994 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-669994:Same reporter
Tested + on June 25 treated with paxlovid. tested negative on July 1.   started sneezing and retested July 8 tested + all with home tests. waiting for provider consult now.
Patient arm was bruised, and she had redness/splotchy all the way down arm. She experienced slight itching in the area also.
Initial information received on 07-Dec-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves female patient who received partial dose of TYPHIM VI (lot number N1K811M and Expiry date 19-Oct-2019) as leakage occurred from where the needle attaches to the LUER LOK of the prefilled syringe and leakage occurred during administration of the, via unknown route in unknown administration site on 06-Dec-2018. The patients past medical history,medical treatments, vaccinations and family history were not provided. It was actual medication case error due to Vaccine under dose. It was also a case of Syringe leak. Reporter said they will need a replacement for this issue. They had reported the AE/PTC on 07Dec2018 and are now requesting a replacement. It was unknown if any adverse event occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the 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. List of documents held by sender: none. Follow up report received from a Pharmacist on 11-Dec-2018. Narrative updated with non-significant information. List of documents held by sender: none.
Employee reported to medical staff itching to site, back, and neck, feeling warmth to whole body, and hives appearing to nape of neck. Ice pack applied, continued to be monitored by medical staff.
This spontaneous report as received from a registered nurser refers to a female patient of unknown age. On an unknown date the patient was vaccinated with a dose of ROTATEQ, orally (dose and lot# not reported). It was reported that patient threw up everything in her stomach during administration of ROTATEQ. The outcome of the event was unknown. The relationship between the ROTATEQ and the event was unknown. Additional information has been requested.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 01-OCT-2013 the patient was vaccinated with M-M-R II (lot # J002502, expiration date 28-FEB-2015). The vaccine was exposed to temperature exposures of 52F, on 29-AUG-2013 for 40 minutes, on 09-SEP-2013 for 1 hr and 25 minutes, on 10-SEP-2013 for 15 minutes, 17-SEP-2013 for 35 minutes, on 19-SEP-2013 for 1 hour and 35 minutes, on 20-SEP-2013 for 40 minutes, on 25-SEP-2013 for 45 minutes, on 26-SEP-2013 for 2 hours and 30 minutes and on 01-OCT-2013 for 4 hours. No known adverse effects. This case is linked to case: 1310USA001610, 1310USA008360, 1310USA008361, 1310USA008362, 1310USA008363, 1310USA008364, 1310USA008365, 1310USA008366, 1310USA008367, 1310USA008368, 1310USA008369, 1310USA008370, 1310USA008371, 1310USA008372, 1310USA008373, 1310USA008374, 1310USA008375, 1310USA008376, 1310USA008378, 1310USA008379, 1310USA008380, 1310USA008381, 1310USA008382, 1310USA008383, 1310USA008384, 1310USA008385, 1310USA008386, 1310USA008387, 1310USA008388, 1310USA008389, 1310USA008390, 1310USA008391, 1310USA008392, 1310USA008393, 1310USA008394, 1310USA008395, 1310USA008396, 1310USA008397, 1310USA008398, 1310USA008399, 1310USA008400, 1310USA008401, 1310USA008402, 1310USA008403, 1310USA008404, 1310USA008405, 1310USA008405, 1310USA008406, 1310USA008407 (same reporter link). Additional information has been requested.