chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The day following the injection, the site was swollen, red and itchy.  During the next ten days, blisters developed from the injection site (in the tissue backside of left arm), all the way down to the elbow and up toward the shoulder.  It was painful and itchy.  The nurse at the Health Department where the vaccine was administered advised me to use Caladryl, which provided some relief.  For some time after the blisters cleared up, the site was itchy with occasional stabs of needle-like pain.  As of this date, it is completely cleared up.
Since vaccine I?ve had extremely sore joints almost making it not possible to work, sever clotty, painful and heavy menstrual cycles to date. And continued fatigue
Narrative: Patient died at 8:30 pm on 4/21/22 at home under the care of Hospice.
Shingles; This spontaneous case was reported by a physician and describes the occurrence of HERPES ZOSTER (Shingles) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    The patient's past medical history included Knee replacement in 2014. Concurrent medical conditions included Knee pain since 2005, Psoriatic arthritis, Difficulty in walking, Joint range of motion decreased, Weakness since January 2019, Arthralgia since January 2019, Swelling of hands since January 2019, Joint swelling since January 2019, Back pain since January 2019, Hand pain since January 2019 and Spinal osteoarthritis since October 2019. Concomitant products included CLONAZEPAM (KLONOPIN) for Anxiety, LEVOTHYROXINE for Hypothyroidism and Supplementation therapy, GABAPENTIN for Nerve pain and Fibromyalgia, FOLIC ACID for Supplementation therapy, PROCAINE HYDROCHLORIDE (NOVOCAINE), PHENETICILLIN POTASSIUM (PENICILLIN B), AMOXICILLIN, CLINDAMYCIN and CEFALEXIN MONOHYDRATE (KEFLEX [CEFALEXIN MONOHYDRATE]) for an unknown indication.   In August 2019, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced HERPES ZOSTER (Shingles). The patient was treated with CELECOXIB (CELEBREX) at an unspecified dose and frequency. On 05-Feb-2021, HERPES ZOSTER (Shingles) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2019, Magnetic resonance imaging: unknown (Inconclusive) DEGENERATION OF SPINE BONE. In October 2019, Spinal X-ray: unknown (Inconclusive) UNKNOWN. In October 2019, X-ray limb: unknown (Inconclusive) UNKNOWN.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered HERPES ZOSTER (Shingles) to be probably related.    Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: follow up received on 10-MAY-2021 and contains non significant information.
23 days after dose 2 of vaccine patient experienced an episode of unconsciousness while descending a flight of stairs at workplace (a client's house) that resulted in a left radius fracture (per x-ray 2/18/21) and a massive left rotator cuff tear and left biceps tear (per MRI on 4/1/21).
I had an unsettling waking event happen to me yesterday morning, so I didn?t feel like I could gather myself to be at an appointment after the event. I was very disoriented upon waking. I could not gather my thoughts and memories. Things like: I knew I was in a city , but didn?t know where the city was in the world; and other things like that. It was as though I had stepped out of my life and didn?t remember enough to step back in. It only lasted maybe 5 min, but was completly disconcerting & disarming. I?ve never had a similar event.  And it came after another disarming 10 min bout of dizziness / sense of off-balancedness and a very slight nausea the night before. It too, was arresting because I had had no alcohol to drink for months. I felt continually better during the early morning and didn?t think about it much during the rest of the day.
The pt's mom noticed a rash starting on 5/23/01. Saw the doctor on 5/24/01. The pt experienced an intense macular erythematous papular rash on face, chest, arms, back and mildly on legs. Education and reassurance was given by the doctor regarding the possibility of a reaction to the MMR vaccine. Treated with Benadryl for the itching.
Pt recv vax on 11/11/98; on same day pt exp achiness & swelling/ red & hot LA to neck w/ joint pain; fever; light headed; chills; nausea; pale; hot flashes; stiff back; weak
Herpes zoster L C6 dermatome, same side/site as vaccine dose was administered
Received ZOSTAVAX 12/29/10. On 12/30/10 pt said injection site was itchy, red, and swollen. Came to clinic on 12/31/10 (+) 3cm x 3.5cm erythematous patch (over injection site), mildly warm, NTTP no swelling, not indurated. Also had erythematous band where bandaid adhesive was. No fever. On 12/31/10 Rx KEFLEX 500mg 1 capsule 3 times daily x 10days.
Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable and patient received doses of the vaccine; No adverse event; doses administered after excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable and patient received doses of the vaccine) and NO ADVERSE EVENT (No adverse event) in a 44-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 20-Oct-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable and patient received doses of the vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable and patient received doses of the vaccine) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable and patient received doses of the vaccine).    Concomitant medications details were not reported by the reporter.  Reportedly, Pharmacist called to discuss a temperature excursion that occurred several days ago in the freezer. the excursion was found out in an audit and all the vaccines were viable.  Treatment details were not reported by the reporter.
feeling a little tired / Patient laid in bed all day/ Patient went to bed; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (feeling a little tired / Patient laid in bed all day/ Patient went to bed) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054A22A, 012L20A and 031L20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included ADALIMUMAB (HUMIRA) and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) from 21-Nov-2021 to an unknown date for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Jun-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2022, the patient experienced FATIGUE (feeling a little tired / Patient laid in bed all day/ Patient went to bed). At the time of the report, FATIGUE (feeling a little tired / Patient laid in bed all day/ Patient went to bed) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.
Patient experience syncope within 1 to 2 minutes after receiving vaccination.  He lost consciousness and EMS was dispatched.  He regained consciousness approximately 45-60 seconds later. Patient began to sweat profusely and his became pale in color.
Not received the 2nd dose of the Moderna COVID-19 vaccine yet; temperature of 100.6 F for 3 days; very sick starting April 4th or 5th; shortness of breath; couldn't eat; lost all taste; very, very weak; couldn't eat; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (very sick starting April 4th or 5th), DYSPNOEA (shortness of breath), DECREASED APPETITE (couldn't eat), AGEUSIA (lost all taste) and ASTHENIA (very, very weak) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19. Concurrent medical conditions included Cholesterol blood increased. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO), METOPROLOL and LOSARTAN for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced ILLNESS (very sick starting April 4th or 5th), DYSPNOEA (shortness of breath), DECREASED APPETITE (couldn't eat), AGEUSIA (lost all taste), ASTHENIA (very, very weak), EATING DISORDER (couldn't eat) and PYREXIA (temperature of 100.6 F for 3 days). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Not received the 2nd dose of the Moderna COVID-19 vaccine yet). At the time of the report, ILLNESS (very sick starting April 4th or 5th), DYSPNOEA (shortness of breath), DECREASED APPETITE (couldn't eat), AGEUSIA (lost all taste), ASTHENIA (very, very weak), EATING DISORDER (couldn't eat) and PYREXIA (temperature of 100.6 F for 3 days) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Not received the 2nd dose of the Moderna COVID-19 vaccine yet) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: unknown (Positive) Covid test positive (She tested negative 20 days later).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included an unknown cholesterol medication.  No treatment information was provided.
TEN MINUTES INTO WAITING AFTER THE SHOT, THE FRONT OF MY TONGUE STARTED TO FEEL TINGLY ,AND THE INSIDES OF MY BODY GOT VERY SHAKEY. I INFORM THE NURSING STAFF AND THEY TOOK MY BLOOD PRESSURE. IT WAS 225/68. I WAS TAKEN TO THE EMERGENCY ROOM WHERE I WAS TRIAGED . MY PRESSSURE CAME DOWN TO 175/68. I WAS KEPT FOR ABOUT AN HOUR AND WAS RELEASED. I HAS FLU LIKE SYMPTONS FOR THE NEXT FEW DAYS WITH A FEVER OF 101. THE FOLLOWING MONDAY, AT WORK, I GOT REALLY SHAKEY AND HAD MY PRESSURE CHECK AGAIN, IT WAS 185/78. I HAVE NEVER HAD AN ISSUE WITH MY BLOOD PRESSURE. I AM NOW ON AMLODIPINE TO CONTROL IT AND CLONIDINE TO TAKE AS PRN.
Information has been received from a registered nurse concerning a 33 week and 5 days old patient who on 16-APR-2010 was vaccinated with the third dose of ROTATEQ (oral, 2 ml single unit dose) at the age of 33 weeks and five days. No adverse effects were reported. Additional information has been requested.
Patient came to the pharmacy complaining of a sore and stiff arm with limited mobility following the administration of a flu vaccine. No swelling or discoloration was noted. It was advised that she schedule an appointment with her primary care provider for further evaluation.
5x6cm induration @ DTAP site;2 other kids had same rxnw/same bottle;
Patient presented to the ED and was subsequently hospitalized for Traumatic hemorrhage of cerebrum without loss of consciousness within 6 weeks of receiving COVID vaccination.
The Patient is a 31 year old female.  Source of patient information was patient.  Source of patient information was medical records.  Past medical history reviewed, problem list reviewed, and medication list reviewed.  Family history not reviewed.  Reliability of source of patient information was good.  No systemic symptoms.  No head symptoms.  No pulmonary symptoms.  No neurological symptoms.  No skin symptoms. Patient reports onset of multiple single red dot like macular rash to left arm and leg 5/20/2019 (day 3 after receipt of 5/17/2019 SPV and AVA1 vaccine).  She denied any outside excursions-recent travels, plant exposure or yard work, bug bites, new soaps-lotions, detergents, food, etc.  On 5/24-25 (day 4-5 post vaccination) she reports the red macular rash itched and was spreading all over her body, biceps, thighs, arms, tops hands/feet (not palms/soles and no oral lesions), chest/back and last to abdomen and neck.  She denied any fever, cp, sob, dizziness, fatigue or other systemic s/s.  She presented to medical on  5/26/2019 c/o rash now hive like (groupings raised but not pustular) x24 hours and was treated with oral benadryl 25 mg 4x/day and prednisone 50 mg x5 day. She was diagnosed with urticaria. She presented to ER 5/28 c/o dizziness, sensation of being "out of breath" (especially after activities), hives, fatigue, nausea whle on Benadryl and prednisone. Labs nl with low K 3.24.  Dx with hypokalemia and given 40 mEq KCL po and released. Lungs reported clear with 100% O2 sats room air. On 5/30/19 she returned to ER again, c/o exhaustion, DOE, fatigue....labs nl, dx fatigue secondary to benadryl use and changed to hydroxyzine.  Provider noted faint wheeze on exam.  She presented to ER again 6/2/19 after "passing out" and assisted to floor.  Orthostatic were positive with HR supine 80 bpm and 110 standing. BP/RR normal.  EKG nl, CMP/UA/preg all nl/neg - not dehydrated per lab and clear UA.  Tx with 1 liter IVNS wide open and release to f/u with HCP.  DX dizziness.  6/3/2019 seen by HCP with c/o nausea, dizziness- exam showed nausea increased with positive dix-hallpike maneuver.  (note pt treated for clinical strep throat on 5/7/2019).  6/20/19: Patient stated all s/s have resolved with no further dizziness, n/v, rash or any other systemic s/s.  Patient stated rash duration was about 3 weeks. duration of dizziness began about 5/28 after starting benadryl and prednisone.  Malaise and fatigue began about 1 week after receipt AVA/SPV and persisted for total of 3 weeks.
This spontaneous report as received from two pharmacists refers to a patient of unknown age and gender. On 21-FEB-2014, the patient was vaccinated with a dose of improperly stored ZOSTAVAX, lot # J007854, expiration date 28-SEP-2014 (dose and route not reported) that was exposed to 28F for 432 hours, Dates of excursions: 01-FEB-2014 to 21-FEB-2014. No adverse effects were reported. This is one several reports received from the same source. Additional information has been requested.
Patient states she woke up the day after vaccine and her arm was red from her shoulder to the elbow. Lasted a few days.
ZOSTAVAX given 4/26, pt called 4/30 - arm red, hot, swollen under arm (axilla) given ADVIL, resolved in few days. But she also had pain back of shoulder up neck - that has recurred evy 2-3 wk for about 3 days. Last episode 3 wk ago.
Pt devel erythema & induration surrounding the inject site p/receiving Typhoid vax; This adverse event has previously been reported directly to the FDA by the reporter;
This spontaneous report as received from a Licensed Vocational Nurse (L.V.N) refers to a multiple unspecified patients of unknown age and gender. Medical history and concurrent conditions were not provided. In unspecified dates during July 2015, the patients were vaccinated with doses of improperly stored PROQUAD (Merck) (dose and route were not reported) lot # K022446 expiry date: 13-MAY-2016, lot# L011080 expiry date: 01-OCT-2016, lot# L005297 expiry date: 17-AUG-2016. There was no concomitant medication provided. No adverse effects reported. This is one of two reports received from the same reporter. Additional information has been requested.
pt went down for nap 2PM; awoke @ 4PM 415PM felt hot; pt given water & APAP; by 430PM began sz activity; about 1 wk a/sz 23JUN92 pt began having small infrequent tremors;
Initial case was received on 28 July 2010 from a healthcare professional. An 11 year old female received on 13 August 2009, a left deltoid intramuscular injection of ADACEL (reported lot number U29133 AA not valid for ADACEL, but is valid for MENACTRA), a right deltoid intramuscular injection of MENACTRA (lot number U2919AA) and a right deltoid intramuscular injection of GARDASIL (Merck lot number 1130X). The patient experienced numbness in both arms and legs since the vaccinations (onset date and time not specified). The patient had no pre-existing medical conditions, no concomitant medications and no known allergies. On 28 July 2010, the patient returned to the physician's office for an annual exam, reported the numbness and stated the symptoms continued. Document's held by sender: None.
Information has been received from a physician concerning a 17 year old female who was vaccinated with a first 0.5 ml dose of Gardasil concomitantly with a dose of MENACTRA. The day after vaccination, the patient experienced low grade fever and aching. Unspecified medical attention was sought. Subsequently, the patient recovered. On an unspecified date the patient was vaccinated with a second dose of Gardasil by itself and there was no reaction. Additional information is not expected.
Over 6 to 12 hours, post vax, child became increasingly irritable and 20 hours, post vax, had generalized seizure with post-ictal depression. Unresponsive for several hours after seizure. The follow-up states that the pt was admitted for further evaluations. Tegretol was initiated with 4cc b.i.d. He continued on Dilantin 25 mg b.i.d. following a Dilantin load. Onset of seizure activity following routine immunization was associated with fever of 104 deg. F. Pt is diagnosed with developmental delay.
Pt to ED 7/21 for SOB, COVID+ two days prior 7/19. Pt is A&Ox2, Respirations even and unlabored. 7/22 pt maintained on Rocephin and Zithromax, add Decadron and remdesivir. 7/23 Pt A&OX3 w/ confusion. 7/24 Sepsis bpa score 9, pt alert with confusion, no distress noted. 7/25 Pt received AxO4 c no c/o pain, pt requested cough suppressant medication for coughing attacks. 7/26 No respiratory distress, pt A&OX4, with some confusion, denies pain or discomfort.  7/27 Pt with no, SOB denies respiratory distress. 7/28 Pt is aox4, on RA, not in distress, denies pain or sob. 7/29 pt discharged.
Drug ineffective; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 37-year-old male patient received BNT162b2 (BNT162B2), on 21Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 37 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "not recovered"; COVID-19 (medically significant), outcome "not recovered", described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2022) Positive, notes: Treatment of COVID-19; (Sep2022) Positive, notes: Positive antigen for 7d w symptoms. Therapeutic measures were taken as a result of covid-19 which include Paxlovid from 16Sep2022 to 21Sep2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case, an association between the reported event drug ineffective, COVID19 and bnt162b2 cannot be ruled out.
Information has been received from a physician concerning a 17 year old female patient who on an unknown date was vaccinated with the first and second dose of GARDASIL. On 18-MAY-2010, the patient was vaccinated with the third dose of GARDASIL. The physician reported that after the patient received the first and second dose of GARDASIL, she started to have vaginal discharge. Then, after the patient received the third dose of GARDASIL, she started to have an irregular period. It was unspecified if the patient sought medical attention. Additional information has been requested.
Severe nausea and vomiting; Severe nausea and vomiting; heart rate as high as 192; dizziness; severe fatigue; heart rate as high as 192; This is a spontaneous report from a contactable other health care professional (Nurse). A 31-year-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EK9231), via an unspecified route of administration in right arm on 07Jan2021 (at the age of 31-year-old) as dose 2, single for COVID-19 immunisation in hospital. Medical history included polycystic ovarian syndrome from an unknown date and unknown if ongoing, obesity from an unknown date and unknown if ongoing, depression from an unknown date and unknown if ongoing. Concomitant medications included DULOXETINE taken for an unspecified indication, start and stop date were not reported; VITAMIN D3 taken for an unspecified indication, start and stop date were not reported; ethinylestradiol, norgestimate (ESTARYLLA) taken for an unspecified indication, start and stop date were not reported. The patient previously took mango c and experienced fruit allergy, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EK7530), via an unspecified route of administration in left arm on 17Dec2020 (at the age of 31-year-old) as dose 1, single for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. It was reported that the patient experienced Severe nausea and vomiting for 7 days after second Pfizer COVID vaccination. On Jan14 2021, tachycardia, dizziness, and severe fatigue started resulting in 2 hospital trips with a heart rate as high as 192. Currently seeing multiple specialists to try to find a diagnosis. Symptoms improved on medication but still experiencing multiple adverse symptoms. The adverse events resulted in visit of doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient underwent lab tests and procedures which included heart rate increased: 192 (unknown units) on 14Jan2021. The treatment was received for all the events. The outcome of the events was reported as not resolved at the time of reporting.  Follow-Up (12Jul2021): Follow-up attempts are completed. No further information is expected.