chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a certified medical assistant concerning a 16 year old female patient with no pertinent medical history and no known drug reactions who on 26-JUN-2009 was vaccinated intramuscularly with the first 0.5ml dose of GARDASIL (lot# 662404/0312Y). On 26-AUG-2009 the patient was vaccinated intramuscularly with the second 0.5ml dose of GARDASIL (lot# 662404/0312Y). There was no concomitant medication. On 19-SEP-2009 the patient developed "seizure-like activity, muscle spasms, shaking and neurological problems" after administration of GARDASIL. The patient was examined by a neurologist in the emergency room and was treated with muscle relaxers. The neurologist reported that the exam was difficult because the patient was in constant motion, flexing and extending her back. She also experiencing nausea and dizziness. The patient was not admitted to hospital. No laboratory diagnostics studies were performed. At the time of this report, the patient was recovering. Upon internal review, seizure-like activity was determined to be an other important medical event. Additional information has been requested.  10/26/09 Received medical records for DOS 9/22. DIAGNOSIS: Back spasms. Visit to ER after activity precipitated back spasms. Feeling of spasms in arms. PE neg except for erratic twitching movements. Spastic movement of torso. Strength 5+ UE/LE. No ataxia. Romberg (-). Treated in ER with Valium. SX resolved. Referred to neuro.  11/02/09 Medical records recievd for DOS 9/30-10/06. Neuro consult note:   Exhibits flexion at the abdomen and umbilicus with extension and semi-fluid movements. Torso movement only. Lasts up to 24 hrs and during sleep. Back discomfort. Neuro exam WNL.  Previous arm movement issue lasted 4 months and was ilicited by playing the drums. Resolved. Previous EEG WNL. Cardiac echo WNL. B/W unremarkable. Increased DNAse B antibody only. Possible conversion disorder. MRI BRain and spine WNL.  Improved with tx. Referred for counseling.
headache & sweating began Tuesday after vaccine, by Wednesday the headache was bad, in bed for 24hours, took motrin 800mg x2, did not help
01/26/04: Pt reports after Pneumovax injection 01/21/04 leaving redness and swollen at left upper arm also reported body aches x 2-3 days 01/21/04 before injection given, pt explained possible side effects and was recommended to take Tylenol and put ice at injection site.  Pt signed after reading.
Patient reports pain at injection site and about an hour later he reports not being able to move his arm at all, especially upward.
Nausea, stomach pain, headache, chills, photophobia, extreme bone/joint/muscle pain, fatigue, right arm decrease mobility, feel hot but no fever, excessive thirst, no appetite, cant turn head to left easily, ears feel full, lack of strength, brain fog
tinnitus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 68 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 09Mar2021 (Batch/Lot number: EN6206) at the age of 68 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Tinnitus", start date: 13Mar2021 (ongoing), notes: first visit with PCP regarding ear issue tympanic membrane injection 13Sep2021; "Hypertension", start date: 05Aug2013 (ongoing), notes: treated 13Sep2021 with losartan + an error (sign withheld) 05Jan2021; "Osteoarthritis", start date: 2018 (unspecified if ongoing), notes: hip replacement in 2019; "Hyperlipidemia", start date: 05Aug2021 (ongoing), notes: treated with atorvastatin. Concomitant medication(s) included: ATORVASTATIN taken for hyperlipidaemia, start date: 2013 (ongoing); LOSARTAN taken for hypertension, start date: 2013 (ongoing). The following information was reported: TINNITUS (medically significant) with onset 13Mar2021, outcome "not recovered", described as "tinnitus". The event "tinnitus" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: magnetic resonance imaging: (22Sep2021) unremarkable, notes: Unremarkable; microscopy: (13Aug2021) normal, notes: ear canals visibly clear; (05Oct2021) unknown results, notes: Unremarkable. Therapeutic measures were taken as a result of tinnitus. Addition information: Prior vaccination was none. The patient received the third dose of BNT162B2 on 01Oct2021 (Batch/Lot number: FE3592) via intramuscular on deltoid (side not documented) as single dose for COVID-19 immunization. It was reported that: Booster dose due to high risk of frequent institutional or occupational exposure to coronavirus (and at risk of serious COVID-19 complications). The event required the initiation of new medication/other treatment/ procedure.
Sensitivity and itching back of hands Sunday 5/2 morning. I thought it was insect bites or dryness. Used lotion to treat. Got worse overnight. Monday 5/3 reported to work at 16:00. rash had started to spread back of hands, wrists, forearms (both arms). Eczema looking rash just beneath injection site left arm.  By 18:30 rash seemed to ?explode? left work abruptly because the soles of my feet had an unmanageable itch. Went to clinic and took my socks off in the car, by the time I arrived to clinic neck looked like I had a sunburn, hot to touch and I was unable to stop scratching.  Was given 60mg of prednisone, and 7 more doses. Took 60mg this morning around 08:00 am, went to work. Started to develop rash again on face and palms of hands and treated with Benadryl and OTC cortisone cream.  Left work abruptly at 15;30, rash was spreading from cheeks, forehead, neck and anything that was  under clothes clinging my body (groin, buttocks, breasts, upper shoulders and collar).  Took a shower with no soap and 20mg of prednisone at 16:00 to calm my skin down, and will continue taking Benadryl. Bad behind knees, any place my skin bends. Pretty much sucks.
Patient was observed for 15min because of their claim of having no known allergies. After the 15 minute observation, I (the pharmacist) cleared her since she did not appear to have any side effects. It was not until later in the evening when I realized that the protocol for the COVID vaccine had changed, and I proceeded to report the event to VAERS.
no adverse effects reported; patient was vaccinated with improperly stored MMR II; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 07-JAN-2019, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (albumin status rHA) one dose, lot # N023024 with expiration date 23-AUG-2019 (frequency, route and anatomical location were not provided) which was reconstituted with sterile diluent (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. No adverse effects reported.  The temperature and time frame were unknown by reporter. There was previously temperature excursions and digital data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011469: US-009507513-1907USA010301: US-009507513-1907USA010302: US-009507513-1907USA010303: US-009507513-1907USA010304: US-009507513-1907USA010305: US-009507513-1907USA010306: US-009507513-1907USA010307: US-009507513-1907USA010308: US-009507513-1907USA010310: US-009507513-1907USA010311: US-009507513-1907USA010312: US-009507513-1907USA010313: US-009507513-1907USA010314: US-009507513-1907USA010315: US-009507513-1907USA010316: US-009507513-1907USA010317: US-009507513-1907USA010318: US-009507513-1907USA010319: US-009507513-1907USA010320: US-009507513-1907USA010321: US-009507513-1907USA010322: US-009507513-1907USA010323: US-009507513-1907USA010324: US-009507513-1907USA010325: US-009507513-1907USA010326: US-009507513-1907USA010327: US-009507513-1907USA010328: US-009507513-1907USA010329: US-009507513-1907USA010330: US-009507513-1907USA010331: US-009507513-1907USA010332: US-009507513-1907USA010333: US-009507513-1907USA010334: US-009507513-1907USA010335: US-009507513-1907USA010336: US-009507513-1907USA010337: US-009507513-1907USA010338: US-009507513-1907USA010339: US-009507513-1907USA010340: US-009507513-1907USA010341: US-009507513-1907USA010342: US-009507513-1907USA010343: US-009507513-1907USA010344: US-009507513-1907USA010345: US-009507513-1907USA010346: US-009507513-1907USA010347: US-009507513-1907USA010348: US-009507513-1907USA010349: US-009507513-1907USA010350: US-009507513-1907USA010351: US-009507513-1907USA010352: US-009507513-1907USA010353: US-009507513-1907USA010354: US-009507513-1907USA010355: US-009507513-1907USA010356: US-009507513-1907USA010357: US-009507513-1907USA010358: US-009507513-1907USA010359: US-009507513-1907USA010360: US-009507513-1907USA010361: US-009507513-1907USA010362: US-009507513-1907USA010363: US-009507513-1907USA010364: US-009507513-1907USA010365: US-009507513-1907USA010366: US-009507513-1907USA010367: US-009507513-1907USA010368: US-009507513-1907USA010369: US-009507513-1907USA010370: US-009507513-1907USA010371: US-009507513-1907USA010372: US-009507513-1907USA010373:
Bell's Palsy occurred on right side of face , beginning 3 days after injection.  Treated with steroids by primary care physician.  Followed up with neurologist who ordered bloodwork and MRI (awaiting results).  3 weeks later, palsy still has not resolved.  It was advised to wait at least 6 weeks and until the palsy is resolved before getting the second Moderna shot.
Small, raised, itchy bumps on wrists, arms, chest, belly, neck, and back/ I would describe the rash as mild; Small, raised, itchy bumps on wrists, arms, chest, belly, neck, and back/ I would describe the rash as mild; Small, raised, itchy bumps on wrists, arms, chest, belly, neck, and back/ I would describe the rash as mild; Small, raised, itchy bumps on wrists, arms, chest, belly, neck, and back/ I would describe the rash as mild; Small, raised, itchy bumps on wrists, arms, chest, belly, neck, and back/ I would describe the rash as mild; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 10 year-old male patient received bnt162b2 (BNT162B2), administration date 09Nov2021 18:45 (Lot number: FK5127) at the age of 10 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Eczema as a child" (unspecified if ongoing); "failure to thrive" (unspecified if ongoing). Concomitant medication(s) included: CYPROHEPTADINE. The following information was reported: RASH (non-serious), RASH (non-serious), RASH (non-serious), RASH PRURITIC (non-serious), RASH PAPULAR (non-serious) all with onset 10Nov2021, outcome "recovering" and all described as "Small, raised, itchy bumps on wrists, arms, chest, belly, neck, and back/ I would describe the rash as mild". Therapeutic measures were not taken as a result of rash, rash, rash, rash pruritic, rash papular. Additional information: The vaccine was administered in the shoulder. The patient did not receive any other vaccine within 4 weeks. The adverse events occurred the day after the vaccination. 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 had no known allergies. No follow-up attempts are possible. No further information is expected.
Marked redness and swelling from site of shot (upper thigh) distantly to and including knee with difficulty ambulating (site of DTaP).
Patient reports noticing 10 days after moderna vaccination a bruise like formation on his inner right bicep. He stated that he thought it was a bruise but states that there is no associated pain, burning, or itching. He gradually as time passed noticed many more similar patches present on back of right upper arm into the axillary area. He then noticed more on his back (over both kidneys) and the right groin as well as the inner left thigh and popliteal area. He is noticing more daily. There is no history of eczema . Petechiae looking patches have not changed, according to patient, since first development at 10 days post moderna vaccination. Patient advised that his second dose will be held until he can see a physician. There were concerns about platelet count or possible allergic reaction to first dose. Patient agreeable to terms.
Mother called on Thursday 8/15/19 asking which vaccine patient got in Right arm. Patient complaining of redness, swelling and pain in right arm starting on Monday 8/12/19. Mom gave ibuprofen. Instructed mom to take to PCP Dr. for assessment.  Talked with Mom later that day. Mom reports started on Bactrim for 10 days and to return for f/u next day. Mom took child for F/U. Nothing new to report.  Patient had Follow up again on Friday 8/23/19 still complaining of pain in arm. Xrays ordered. No further reports received from PCP office.
no adverse event; VAQTA was inadvertently administered after its labeled expiry date; This spontaneous report was received from a registered nurse and refers to a 23-year-old patient of an unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant medication provided. On 26-JAN-2021 the patient was vaccinated with expired hepatitis a vaccine, inactivated(VAQTA) vial, 1 dose, lot # S037821 with expiration date on 07-JAN-2021 (exact dose, route of administration were unknown) for prophylaxis. No adverse event was reported.
tested positive after getting the Pfizer COVID-19 vaccine; tested positive after getting the Pfizer COVID-19 vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (159558).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive after getting the Pfizer COVID-19 vaccine". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I believe they tested positive after getting the Pfizer COVID-19 vaccine. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Headache- Thursday 3-11-21-- took tylenol Feeling listless 3-12-21 Severe Dizziness in the middle of the night 3-14-21 All adverse symptoms went away on there own.
Severe abdominal pain, nausea, headache, treated at local hospital for nausea and pain. Labwork done, and CT scan. CT scan showed inflamed intestines and bowels. Given IV fluids, nausea meds and pain meds. Released and sent home.
I DON'T LIKE THE SIDE EFFECTS I GOT; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced i don't like the side effects i got. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of i don't like the side effects i got was not reported. This report was non-serious.
Narrative: This not an ADE or an ADR. Reporting a dispensing error with covid- 19 vaccine during inpatient admission of a 30 yo male admitted for evaluation. MD had ordered a booster dose (0.25ml) (dose #3) of covid vaccine (moderna) on 01/31/2022 at 19:33. On 2/1/22 at 09:57 Md cancelled the order. Nurse did not notice the order was cancelled and gave the vaccine on 2/1/22 at 17:20. Also the given was a full dose (0.5ml). Pt had previously received covid vaccines doses (Pfizer) on 4/5/21 & 4/26/21 at outside facility. Pt did not suffer any adverse reactions from receiving this vaccine in error.
Patient came to pharmacy complaining that he is having the burning sensation at the right side of his abdomen e.g. like sunburn. There was no rash or pain. Patient was directed to the doctor with the possible adverse reaction from Zostavax. On 11/11/2012 his doctor had prescribe him Acyclovir 800mg 5 times a day for 7 days. When patient came to pick his prescription he mentioned me that he is having a mild rash but no pain at the same site he has a burning sensation.
Swollen underarm lymph node; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen underarm lymph node) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (Swollen underarm lymph node). At the time of the report, LYMPHADENOPATHY (Swollen underarm lymph node) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No information regarding corrective treatment was reported by the patient.     Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Non -significant follow-up received she just wanted to know the deadline to send the AE form to safety
Responded with dime size reaction at injection site evening of first day - red, slightly raised. Reaction expanded to greater than a nickel size on 2nd day. Today (3rd day post vaccine) is 6cm x 4cm red, slightly raised, firm, induration, warm to touch. Defined edges, no streaking.
pt in SNF; tested positive for COVID on 12/27/21; given Solu-Medrol, DuoNeb treatments, ABX; DNI; pt went into cardiac arrest; CPR unsuccessful and pt died in the facility
Extreme fatigue, headache, fever, body ache, very sore arm, red rash on arm, diarrhea, thirst, lack of appetite on day after vaccine. Much better but not 100% day 2, energy is back
was not hungry; stayed in bed for four days; did not feel good; sugar levels runs at 600; Sick; tired; itch/starting to itch; Osteoarthritis/having issues with her joints , had lumps on her joints. She was stiff and in a lot of pain.; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (was not hungry), BEDRIDDEN (stayed in bed for four days), MALAISE (did not feel good), HYPERGLYCAEMIA (sugar levels runs at 600) and ILLNESS (Sick) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced DECREASED APPETITE (was not hungry), BEDRIDDEN (stayed in bed for four days), MALAISE (did not feel good), HYPERGLYCAEMIA (sugar levels runs at 600), ILLNESS (Sick), FATIGUE (tired), PRURITUS (itch/starting to itch) and OSTEOARTHRITIS (Osteoarthritis/having issues with her joints , had lumps on her joints. She was stiff and in a lot of pain.). At the time of the report, DECREASED APPETITE (was not hungry), BEDRIDDEN (stayed in bed for four days), MALAISE (did not feel good), HYPERGLYCAEMIA (sugar levels runs at 600), ILLNESS (Sick), FATIGUE (tired), PRURITUS (itch/starting to itch) and OSTEOARTHRITIS (Osteoarthritis/having issues with her joints , had lumps on her joints. She was stiff and in a lot of pain.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: 600 (High) 600.         Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.  Causality of RISANKIZUMAB (SKYRIZI) was reported as the reporter's causality for the events itch, osteoarthritis, was not hungry, stayed in bed for four days, did not feel good, sugar level run at 600 and tired was not provided.
Dizziness.  Client c/o dizziness, assessed by onsite paramedic.  Vital Signs done by medics.  Client hydrated, states feeling better and refused EMT offer to be taken to be checked at the hospital. Client remained in observation for an additional 15 min.  Denied any further symptoms.  Instructed to seek medical attention for any further symptoms experienced.
It just occurred to me that my period has been irregular a little over a year now. Coinciding with my dtap mmr vaccines. I submitted an adverse event on July 9, 2020.  #192640; I was attributing it to possible pre menopause.. But remembering now since when my cycle has been disrupted. I've always had a strong, healthy, beautifully regular period, with little to no pms symptoms.
Fever; chills; headache; body aches; night sweats; Felt very sick; This is a spontaneous report from a contactable consumer. A 71 year old elderly male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: not reported), via an unspecified route of administration, administered in left arm on 03Mar2021 at 09:30 as dose 1, single for covid-19 immunisation. Medical history included covid-19. He had Covid 3 months before vaccination. No known allergies. There were no concomitant medications. No other vaccine in four weeks. No other medications in two weeks. Covid not tested post vaccination. On 03Mar2021, the patient experienced fever, chills, headache, body aches, night sweats for a week. Symptoms lasted for over 48 hours. Worse than when he had Covid 3 months before. Felt very sick. He was afraid to take the next shot. The treatment not received for events. The outcome of events was recovered in Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
NEUROPATHY 3/14/2022 --  RECURRENCE OF SAME SYMPTOMS
Irritation to injection site, raised red rash, on tricep of right arm. Size of rash is 9x5 cm.
Six hours after receiving the injection I had overwhelming fatigue. I felt foggy. I was driving home and I did not feel safe operating my car. I got home and I didn't do anything else the rest of the day. That night I experienced severe abdominal cramping. I woke up feeling fatigue, I had a headache, I felt chills and had a slight fever. I felt nauseous and had multiple loose stools that I couldn't control. This continued throughout Tuesday and all day Wednesday. I could make it to the restroom, but it was definitely a fecal emergency. When I woke up on Thursday, I felt better. I didn't really feel normal until Saturday (5 days after receiving the vaccine).
lightheaded, pale, BP 110/80 P=80 monitored every 5 min. BP 11/50 P=70. Pt. vomited , weakness, shaky. Pt on sz and nerve meds - ran out 1 week before - trans. to Hosp. in stable condition with only weakness/shaky.