chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a registered nurse and refers to multiple patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On unknown dates, the patients were vaccinated with improperly stored doses (incorrect product storage) of GARDASIL (lot, expiration date and dose were unknown) for prophylaxis for a year. No adverse effects reported. No product quality complaint was filed. This is one of several reports received from the same reporter. Follow up information has been received on 07-DEC-2016. All telephone attempts to obtain follow-up information have been unsuccessful. No additional information is available. Additional information has been requested.; Sender's Comments:  US-009507513-1610USA008984: US-009507513-1610USA008979: US-009507513-1610USA008977: US-009507513-1610USA008851: US-009507513-1610USA008982: US-009507513-1610USA008988: US-009507513-1610USA009024:, MERCK 1610USA008986:Mfr number.
Shoulder developed pain and swelling over course of a few days. MD gave patient prednisone tabs and pain and swelling are resolving.
Fever from time woke up on the 18th until went to sleep on the 19th. Shoulder is red and inflamed with goosebumps on it started at same time as fever and is growing larger still swollen on the 20th at 7pm
PATIENT WAS FOUND DROWN IN BATHTUB AT HOME. REASON FOR DEATH: LYMOCYTIC MYOCARDITIS
This spontaneous report as received from a physician and a nurse refers to a male patient of unknown age. The patient was vaccinated with 0.65 ml ZOSTAVAX (lot # was unknown) on 25-JAN-2013. No concomitant medications were reported. On 28-JAN-2013 the patient experienced a severe case of shingles. Location of rash was T4 on left side. The relatedness for a severe case of shingles was unknown for ZOSTAVAX. Additional information is not expected.
I received my vaccine on 03-24-2021. Two weeks ago, I had a routine mammogram and sonogram.  I am now going on Monday for biopsy 08-09-2021.  Last Wednesday 07-28-2021 I had a follow up, that dictates the biopsy that I will be having on Monday 08-09-2021. I will also be having a repeat mammogram with contrast and another sonogram on my left breast.
In 2/99 and 5/99, the pt received his 1st and 2nd dose of Lymerix and after the 2nd dose, he experienced low back pain. No treatment was given. The most recent information received on 6/22/00, reports the outcome of the event as unresolved.
at 3am I woke up with a racing heart rate and mild burning in my belly. I couldnt go back to sleep. The next day the burning in the belly got worse. My stomach became bloated and I was having shortness of breath walking short distances. The racing heart and chest pain ebbed and flowed.  I made a video appointment with my PCP group  on Thursday and they prescribed omeprazole and asked me to come in for physical exam the next day. When I went in the symptoms persisted, they did blood work, did a chest x-ray and sent me over to the emergency room. At the ER they did an EKG, more blood tests and recommended I have a abdominal CT on an outpatient basis. They couldnt say my symptoms were a result of the Pfizer shot but they could not rule it out that it was related to the shot.
First night (2/26) woke up very itchy all over body, no visible rash.  Today (3/9)  woke up with COVID arm ring around injection site; brighter red ring with bruise-y red inside. About 1 inch tall and 2 inches wide. No pain to touch, maybe slightly warm?
Having pain when attempts to turn her arm; swelling and inflammation in same arm as injection; swelling and inflammation in same arm as injection; This is a spontaneous report from a contactable pharmacist. A 76-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) (lot# AG8353, Exp date Jun2021, NDC 00005-1971-02), intramuscular in deltoid left, on 30Oct2019, at 0.5 ml single, for immunisation. Medical history and concomitant medications were none. The patient experienced swelling and inflammation in same arm as injection on 31Oct2019 with outcome of not recovered. The events were considered medically significant. The patient saw her doctor on 04Nov2019 and 06Nov2019. The doctor initially thought it was something else, but now believes it may be a reaction to the vaccination. The reaction started out as some swelling and irritation below the injection site and then it increased up toward the injection site and then went down to patient's hand. Therapeutic measures were taken as a result of the events and included treatment with Clindamycin at 300 mg 3x/day, that was changed to Keflex at 500 mg 3x/day as well as Benadryl. The patient stated her arm was still swollen at this time and she indicated having pain when attempted to turn her arm.; Sender's Comments: There is a reasonable possibility that the events "swelling and inflammation in same arm as injection" were related to pneumococcal 13-valent conjugate vaccine based on known drug safety profile.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Client arrived for HBV vaccine today 02/17/2022 @ 0812 . Client reviewed ?Screening Checklist for Contraindications to Vaccines for Adults.?  All answers reported as No. Client received Hepatitis B vaccine.  Client seated for HBV vaccine. Client alert and oriented. Client remained seated for at least 5 min. Client stood to leave and appeared dazed and confused. RN asked client if he was ok. No response received. Client experienced syncope. RN assisted client to floor in a controlled fall. RN called for help. PA, LPN came to assist. Client was laying on the floor. LPN brought ice packs to room. Client woke up and stood up. Client briefly fainted again and RN was able to get client to a chair. Client sitting in chair. Ice packs provided to back of neck, lollipop provided to client. Client offered water and drank some water. MD, APRN came in to assist.  Client fainted again. Experienced brief seizure-like activity one time lasting no longer than 5 seconds. Vitals BP 70/43 P 51 O2 91.  Client was confused. Appeared to be going in and out of consciousness. Ammonia ampule broken and placed under client?s nose. Client briefly aroused.  LPN in room. RN advised LPN to call EMS.  RN retrieved O2 tank and placed face mask on client with O2 at 2 L/Min. Repeat of vitals about 5 min later 79/53 P 59, SPO2 98%. Client disoriented.  Client asked if he had eaten today. States he only eats once a day in the evening. Blood sugar analysis was not performed. EMT arrived on site. EMT briefed by RN. Client more alert and oriented at this time. Client able to stand and walk to the stretcher. EMT left Immunization clinic at 0900 with client. EMT will transport client to Hospital.
patient reports red raised area to left arm at injection site. Area measures 30mm x 25mm. Reaction started 1/19/2021 at 8pm
HAD THAT TOO; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not 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 covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced had that too. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of had that too was not reported. This report was non-serious.
her arm swollen a little bit; Vaccination site swelling; vaccination site erythema; arm is a little sore; arm itches from the shot I took; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (arm itches from the shot I took), PAIN IN EXTREMITY (arm is a little sore), PERIPHERAL SWELLING (her arm swollen a little bit), VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE ERYTHEMA (vaccination site erythema) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 002C21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension (blood pressure). Concomitant products included CHLORTALIDONE (CHLORTHALIDONE) for Blood pressure high, METFORMIN, OMEPRAZOLE, ASPIRIN [ACETYLSALICYLIC ACID], MULTIVITAMINS [VITAMINS NOS], AMITRIPTYLINE, METOPROLOL, ATORVASTATIN CALCIUM (LIPITOR), LISINOPRIL and DOCUSATE for an unknown indication.   On 26-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Aug-2021, the patient experienced PRURITUS (arm itches from the shot I took) and PAIN IN EXTREMITY (arm is a little sore). On 31-Aug-2021, the patient experienced PERIPHERAL SWELLING (her arm swollen a little bit), VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE ERYTHEMA (vaccination site erythema). At the time of the report, PRURITUS (arm itches from the shot I took), PAIN IN EXTREMITY (arm is a little sore), PERIPHERAL SWELLING (her arm swollen a little bit), VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE ERYTHEMA (vaccination site erythema) outcome was unknown.            Treatment information was not provided.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A female patient received BNT162b2 (BNT162B2), on 22Apr2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for COVID-19 Immunization. The following information was reported: HERPES ZOSTER (non-serious) with onset Apr2021, outcome "unknown", described as "shingles". Additional information: The patient experienced shingles 3 days after her 2nd vaccination of Comirnaty. She received a booster shot Nov2021 and did not have shingles then. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 14-Jan-2023, Dose was administered on 22-FEB-2023) and NO ADVERSE EVENT (no adverse event) in an 80-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 016H22A) for COVID-19 prophylaxis.  No Medical History information was reported. On 22-Feb-2023, 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 22-Feb-2023, after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use by Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 14-Jan-2023, Dose was administered on 22-FEB-2023) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 14-Jan-2023, Dose was administered on 22-FEB-2023) 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 EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 14-Jan-2023, Dose was administered on 22-FEB-2023). No concomitant medication was reported.  Date the vial was initially stored in the refrigerator on 14-Jan-2023. The vial did not undergo any temperature excursions. No treatment information was reported. This case is for patient 2 of 3. This case was linked to US-MODERNATX, INC.-MOD-2023-716921, US-MODERNATX, INC.-MOD-2023-716965 (E2B Linked Report). Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716921:Patient 1. US-MODERNATX, INC.-MOD-2023-716965:Patient 3.
Itchy welt 1 inch in diameter about 10-12 hours after vaccination. It then grew to about 6 inches in diameter by about 36 hours after vaccination. (Covid arm).
Pt recvd vax & exp elevated liver function tests sometime after the 3rd dose;
Same as last time, immediate listlessness, glazed over look for the rest of the night. Extreme crankiness and constant crying for days following. Bad rash on face.
Combined initial and follow up reports received from a consumer and a pharmacist on 08 NOV 2010 and 15 NOV 2010, respectively: This child patient had been vaccinated with influenza virus vaccine during last year. The child was vaccinated with one dose of FLUVIRIN (batch  number 111771P1) 0.5 ml, intramuscularly on 05 Nov 2010. After vaccination, the child experienced first episode of seizure on 08 Nov 2010 about 12:30 am. Second episode occurred at about 3.5 hours later and third episode occurred at another 4 hours later. The child was hospitalized on an unknown date. No previous history of seizure was reported. Final outcome of the events was not reported.
Patient experienced soreness, redness, and warmth at injection site as well as an upset stomach and ill feeling for about 3 days after injection. Symptoms have since resolved with no other adverse reactions reported.
Info has been received from a health professional concerning an 11 year old male with no allergies or medical conditions who on 6/6/98 was vaccinated, SC in the right arm with a 1st dose of varicella virus vaccine live (lot 617072/1661B). There was no illness at the time of vaccination. On 12/22/05, the pt experienced a rash on the face. The rash progressed and the child was seen in the office on 12/23/05. The dx was post Varivax varicella. No labs were done. Outcome was not reported. Additional info has been requested.
pt recvd vax & a couple days later exp low grade fever, macular rash w/raised borders on extremities & trunk & palpable lymph nodes; pt had a viral synd;
7/6/21 PMH significant for HTN,gout,obesity, HLD, recurrent UTI; presented for waxing and waning RLQ and right flank pain
Redness, soreness at injection site; no fever, shaking, chills, and no evidence of cellulitis.
mom reports pt started w/a rash around neck & behind ear; pt has a welt;
Flulaval PFS vaccine that was activated on 14May2020 and not administered; This case was reported by a nurse via call center representative and described the occurrence of product storage error in a patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) for prophylaxis.   On 14th May 2020, the patient received FluLaval Tetra 2019-2020 season. On 14th May 2020, unknown after receiving FluLaval Tetra 2019-2020 season, the patient experienced product storage error. On an unknown date, the outcome of the product storage error was unknown.  Additional information was provided as follows: The age at vaccination was not applicable for this report. The nurse reported that they had a Flulaval PFS vaccine that was activated and not administered, they stored it, which led to product storage error. The nurse did not specify if they are going to administer it or not. The reporter did not consent to follow up.
Draining sinus for 2 days,  itching, small bumps/rash on arms, legs, body
Rash around area of injection started 6/16 after receiving shot. Worsened in morning rash slightly red, pruritic, mildly painful.
Dead arm, numb, tingly, unable to raise/lift, push up, carry, etc. Treatment - MRI showed shot went into bone. Cortisone shot and physical therapy. Follow up to be determined.
REDNESS AROUND CAT SCRATCH; SWELLING  AREA  AROUND CAT SCRATCH; TIRED; This spontaneous report received from a health care professional concerned an 8 decade old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included cat scratch.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 16-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 16-JUN-2021, the subject experienced redness around cat scratch. On 16-JUN-2021, the subject experienced swelling area around cat scratch. On 16-JUN-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tired, redness around cat scratch and swelling area around cat scratch was not reported. This report was non-serious.
Eight days, post vax, pt developed a low fever and urticarial rash which spread to the trunk and extremities. No treatment.
One half hour post vax, the pt developed nausea, vomiting, and diarrhea.
Vial was initially stored in refrigerator on 19-AUG-2022 and administered on 19-SEP-2022; No adverse event; Received an expired 2nd primary dose after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received an expired 2nd primary dose after 30-day Use By Date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 19-AUG-2022 and administered on 19-SEP-2022) and NO ADVERSE EVENT (No adverse event) in a 28-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 053B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Sep-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 19-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received an expired 2nd primary dose after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 19-AUG-2022 and administered on 19-SEP-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received an expired 2nd primary dose after 30-day Use By Date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 19-AUG-2022 and administered on 19-SEP-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Received an expired 2nd primary dose after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 19-AUG-2022 and administered on 19-SEP-2022).    Vial size was reported as 5.5 ml  NDC 80777-0273-99 Unpunctured in broken cartons  (Unpunctured vials) and vial doesn't undergo any temperature excursions. No concomitant information were reported by the reporter. No treatment information were reported by the reporter.
Worsening or exacerbation of my existing tinnitus  - I saw an ENT physician , who said it was vaccine related . It has not resolved and can be distressing to me
I woke up the following morning with pain and inflammation in RT armpit.. by midday the swelling in armpit lymph nodes was the size of a very large egg.  I couldn't comfortably put my arm down at my side.  Pain radiated down arm to elbow, and up neck into ears.  I had fever of 100.1, but took ibuprofen to try and alleviate pain.  The symptoms lasted about 5 days.
Symptoms started on 03.15.3022. Swelling on right arm at crook, nothing at injection site.  Poc  marks developed as well where swelling was, armpits, shoulder blade and legs all right side. Swelling increased became very red and hot to touch, itching all where marks were.  I was taking Benadryl and applying cortisone cream.  On Friday went to walk in, advised not much they can do stop taking Benadryl.  On 0321.2021 hives broke out all on right arm started Benadryl again. Still have them now over a week later.
Tingling all over body (back, legs, back of arms) with any yard work/quick jog/long walk/body heat/body sweat, described as tiny little tingles, not super painful but annoying and on outer skin, like brushing up against something, touch doesn't alleviate anything
fatigue; Injection site pain; stomach pain, indigestion which she had to take acid reflux medicine.; felt like her head was on fire; burning in head; chills; dizziness; a vertigo episode.; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), VACCINATION SITE PAIN (Injection site pain), ABDOMINAL PAIN UPPER (stomach pain, indigestion which she had to take acid reflux medicine.), FEELING ABNORMAL (felt like her head was on fire) and MIGRAINE (burning in head) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     no historical conditions provided by the reporter.    On an unknown date, the patient received first 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) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (fatigue), VACCINATION SITE PAIN (Injection site pain), ABDOMINAL PAIN UPPER (stomach pain, indigestion which she had to take acid reflux medicine.), FEELING ABNORMAL (felt like her head was on fire), MIGRAINE (burning in head), CHILLS (chills), DIZZINESS (dizziness) and VERTIGO (a vertigo episode.). At the time of the report, FATIGUE (fatigue), VACCINATION SITE PAIN (Injection site pain), ABDOMINAL PAIN UPPER (stomach pain, indigestion which she had to take acid reflux medicine.), FEELING ABNORMAL (felt like her head was on fire), MIGRAINE (burning in head), CHILLS (chills), DIZZINESS (dizziness) and VERTIGO (a vertigo episode.) outcome was unknown. Not Provided          No Concomitant medications were provided No Treatment information provided    This case was linked to MOD21-096687 (Patient Link).
"Administered - 10:35 Adverse event started - 10:37 Patient had light dizziness. BP 87/52 (patient stated this is her normal BP) -- > 90/60, HR 65, O2 = 99%. Patient stable, released from vaccination site."
Fever to 105 axillary. Irritability, unconsolable; high pitched cry.
I'm a registered RN at medical center. I received two doses of Pfizer COVID vaccine. I had no pre-existing medical conditions. After couple weeks I developed sudden onset chest pain. I went to the hospital because I thought I was having a heart attack. I wet through a heart catheterization with no vessel blockages and my EKG was reading NSTEMI. I was hospitalized for a total of two weeks. I was on high doses of anti-inflammatory medication.
Awoke 12/1/18 feeling "sore - almost flu-like". Took ibuprofen twice that day and rested all day. Her last dose was around 8 pm. Then woke around 1 or 2 AM drenched in sweat - head, neck, and upper back.
24 hours after MMR & HIB, child was "spaced" out 5 hours, became febrile, had a tonic seizure 10 seconds, eye up in head, unresponsive. Had (2) ER visits same day due to lethargy.