chrisvoncsefalvay/vaers-outcomes huggingface dataset:
blisters on the face; This case was reported by a pharmacist via call center representative and described the occurrence of blister in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced blister. On an unknown date, the outcome of the blister was unknown.   It was unknown if the reporter considered the blister to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was captured as adult as per the vaccine indication. The age at vaccination was not reported. After receiving Shingrix, the patient experienced blisters on the face. The reporter was not sure yet if it was related or not to the vaccination. No other information was provided. The reporter consented to follow up.
Swelling of the lips; hives on upper body; This is a spontaneous report from a contactable consumer (patient).   A 72-years-old male patient received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EM9810), via an unspecified route of administration on 09Feb2021 15:30 (at the age of 72 years old) as dose number unknown, single for COVID-19 immunisation. The patient medical history was reported as none and there was concomitant medication in two weeks (also reported as there was other medication in two weeks). Known allergies was reported as not sure. On 27Feb2021, the patient experienced swelling of the lips, and hives on upper body. There was no other vaccine in four weeks. The events resulted in Emergency room/department or urgent care. Patient had no COVID prior vaccination and not COVID tested post vaccination. Treatment was received on all events. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Symptoms began with tingling in back of throat on left side.  Within 30 minutes I was having difficulty swallowing and hives began to appear on chest and arms.  I was given Benadryl through IV about 10:45.  I was taken by ambulance to hospital and remained there for about an hour and a half until symptoms subsided
No adverse effect from the vaccine.  Please update this form.  All I wanted to do was report that I contacted covid-19 on 5/10/2023.  I signed up  for V-safe checkins when I received my first covid vaccine shot and have been responding to the email check ins.   They said  to report new symptoms can be reported to VAERS.  There's nothing in this form to enter this information. or that I started taking Paxlovid on 5/11/2023 that my doctor called in to the pharmacy.
A red welt at site of injection causing an itchy stinging sensation-spreading. Very hot to touch. Directed to Dr.
Within a couple of hours, severe chills, fever, muscle and joint pain began. These are ongoing.
Patient developed mild rash around injection site.  No other signs or symptoms of anaphylaxis.  Treated with 50mg PO diphenhydramine in clinic and given PO diphenhydramine and hydrocortisone cream for home.
No adverse event; Administration error: dose administered after 30-day use by date; Patient received 1st dose on 19Jul2022 and 2nd dose on 15Sep2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration error: dose administered after 30-day use by date), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st dose on 19Jul2022 and 2nd dose on 15Sep2022) and NO ADVERSE EVENT (No adverse event) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052B22A and 051B22A) for COVID-19 vaccination.     Patient had no allergies. Patient had no history relating to adverse event and both acute and chronic illnesses at the time of vaccination.    On 19-Jul-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Sep-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration error: dose administered after 30-day use by date) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st dose on 19Jul2022 and 2nd dose on 15Sep2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration error: dose administered after 30-day use by date), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st dose on 19Jul2022 and 2nd dose on 15Sep2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administration error: dose administered after 30-day use by date) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st dose on 19Jul2022 and 2nd dose on 15Sep2022).    Patient did not received other vaccines within one month prior to Moderna. No concomitant medications were reported. Vial of Moderna COVID-19 vaccine was stored in the fridge since 15-Aug-2022 and was inadvertently administered on 15-Sep-2022. Patient did not report any adverse event after the vaccine was given. No treatment medications were reported.
COVID breakthrough first vax 3/15/2021. still hospitalized.  A 64-year-old man uses oxygen at bedtime specifically nasal cannula 2 L. He was not feeling well 3 days ago for which he decided to go to the pharmacy for over-the-counter COVID-19 test that came positive.  Patient continued having worsening of the symptoms specially body aches and fatigue on exertion, no fever.
it's making me tired; I also have a sore arm; Just slept like I've never slept before; booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 01Dec2021 (Batch/Lot number: unknown) at the age of 34 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2), administration date: 05Apr2021, when the patient was 33 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1), administration date: 05Mar2021, when the patient was 33 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 01Dec2021, outcome "unknown", described as "booster"; FATIGUE (non-serious) with onset 02Dec2021, outcome "unknown", described as "it's making me tired"; PAIN IN EXTREMITY (non-serious) with onset 02Dec2021, outcome "unknown", described as "I also have a sore arm"; SOMNOLENCE (non-serious) with onset 02Dec2021, outcome "unknown", described as "Just slept like I've never slept before". Therapeutic measures were not taken as a result of fatigue, pain in extremity, somnolence.  Additional information: Prior to vaccination, the patient was not diagnosed with covid-19 and since the vaccination, the patient had not been tested for covid-19. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
NAUSEA; TIREDNESS; HEADACHE; TEMPERATURE 99 DEGREES; BODY ACHES; INJECTION SITE REDNESS; SORE ARM; This spontaneous report received from a vaccine facility concerned a 68 year old female. The patient's weight was 195 pounds, and height was 173.73 centimeters. The patient's concurrent conditions included alcohol use, and non-smoker, and other pre-existing medical conditions included no history of drug abuse. The patient experienced drug allergy when treated with amoxicillin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and batch number: 1805018 expiry: 25-MAY-2021) dose was not reported, administered on 07-MAR-2021 13:30 on left arm for prophylactic vaccination. Concomitant medications included atorvastatin for cholesterol, venlafaxine hydrochloride for hot flashes, colecalciferol for immune health, ascorbic acid/rosa canina/sodium ascorbate for immune support, and ascorbic acid/biotin/calcium pantothenate/choline bitartrate/colecalciferol/cyanocobalamin/dl-alpha tocopheryl acetate/folic acid/inositol/inulin/magnesium citrate/nicotinamide/pyridoxine hydrochloride/retinol palmitate/zinc citrate for overall health. On MAR-2021, the subject experienced sore arm. On 07-MAR-2021, the subject experienced injection site redness. On 08-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 99 deg. On 08-MAR-2021 11:30, the subject experienced body aches. On 08-MAR-2021 11:30, the subject experienced nausea. On 08-MAR-2021 11:30, the subject experienced tiredness. On 08-MAR-2021 11:30, the subject experienced headache. On 08-MAR-2021 11:30, the subject experienced temperature 99 degrees. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, sore arm, injection site redness, nausea, tiredness, headache, and temperature 99 degrees on MAR-2021. This report was non-serious.
Patient was given a Pfizer booster that had ben thawed in the refrigerator for 32 days.  The vial's beyond use date was 12/11/2021, and was supposed to be discard at the end of shift on Saturday 12/11/2021.  It was still in our refrigerator Monday 12/13/21 when we reopened and 1 dose was given before this error was noticed.
Patient received Janssen COVID vaccine on 4/8/2021.  Patient hospitalized with COVID and respiratory failure on 1/2/22
Pt recvd 3rd hep B vax JAN91 & later exp lymphadenopathy.
Pain in arm, arm weakness, pins and needles in fingers within minutes of vaccine. Increasing pain over time. Especially lethargic and sleepy. Dizziness, vertigo-like
My son was perfectly healthy and after vaccines he began running a 105 fever. I immediately contacted his pediatrician and he explained this was normal after vaccines to get a fever and that he would be fine. I knew something was wrong as he was inconsolable when awake and slept a lot which was not like him at all. I was continuously reassured by his pediatrician that he would be fine.
PROLIA injection was given on Sept. 24, 2018 as well as a flu vaccine. By October 12, patient experienced atrial fibrillation. Although patient has a history of atrial fibrillation, the condition was surgically corrected years ago and has generally been in a normal rhythm for years. Patient has had previous doses of PROLIA with no adverse effects.
Anaphylaxis with throat tightness, shortness of breath, unable to talk (no hives).
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX vaccine to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On an unknown date in 2012, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 13-FEB-2013, the patient was treated by a healthcare provider for shingles. And in April 2013, the patient was treated by another healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Pt recvd MMR vax on 18NOV91 & on 6DEC91 pt devel lt facial swelling w/mild erythema over parotid gland; pt seen by MD; parotitis resolved w/in 48 hrs;
I asked pt if he felt ok after I administered his shot and he said yes, then said he felt lightheaded and fainted. I had my tech call 911 and I administered EPI-PEN. Ambulance came in < 5 mins. and took him to ER.  3/26/09 Received hospital medical records of 3/18-3/20/2009. FINAL DX: syncope, vasovagal; hypokalemia; hypophosphatemia; atrial fib, transient & resolved; HA; cerebral concussion. Records reveal patient experienced lightheadedness, fell backwards & hit head, eyes rolled backwards, feet turned inward, arms stiff, (+) LOC for several minutes. Amnesia, HA & atrial fib in ER.  Had been tx on scene w/epi. Cardio consult done. Converted back to NSR after electrolyte replacement.
Patient monitored for 15 minutes following injection with no side effects. Patient call an hour following injection stating that she had "sweaty palms" and that her "heart is racing and I feel like I am going to pass out". Patient urged to come into urgent care to be evaluated. Patient was evaluated by provider  and was discharged home.
Patient came to the ED with chest tightness and shortness of breath.  Patient was admitted with Covid and treated with remdesivir.
DIZZINESS, NAUSEA, CRAMPS, DIARRHEA, HEADACHE, FATIGUE.
Day 3- started feeling naucious, dizzy and a headache and it hasnt gone away
24 patients given Moderna vaccine after vials were refrozen; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (24 patients given Moderna vaccine after vials were refrozen) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (24 patients given Moderna vaccine after vials were refrozen). At the time of the report, PRODUCT STORAGE ERROR (24 patients given Moderna vaccine after vials were refrozen) had resolved.        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 concomitant medication reported.  No treatment information provided.
Dose 1 Moderna received on 2/17/2021 Lot # 02M20A Pt hospitalized and died at on 6/19/2022 from renal carcinoma, failure to thrive and Covid 19 infection
Pt. reported to PCP (& Occupational Health clinic) body aches, chills, low-grade fever (38 C), nausea; pain, redness and swelling at the site of injection. PCP recommended (via telephone consult) to take Advil and OTC antihistamine.
No additional AEs were reported; The medical assistant is reporting that a patient received improperly stored vaccine; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 04-MAY-2023, the patient received an improperly stored hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 0.5 milliliter/once, lot # X004813 with expiration date of 28-JUL-2024, for prophylaxis (route of administration and anatomical location were not provided).  The improperly storage lasted 2 minutes at temperature of 46.74 F. No previous temperature excursion and no additional adverse events were reported.
Vertigo; This is a spontaneous report from a non-contactable consumer, the patient. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0153) via an unspecified route of administration in the left arm on 14Apr2021 at 10:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included vasodepressor syncope and allergy to latex. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included vitamin d nos (MANUFACTURER UNKNOWN); taken for unknown indication from an unknown date and unknown if ongoing. The patient previously received sulfamethoxazole; trimethoprim(BACTRIM) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the left arm on 23Mar2021 at 10:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. On 14Apr2021 at 21:00, within 12 hours of the vaccination, the patient experienced vertigo. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of event which included treatment with unspecified medication. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event vertigo was recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
Preliminary: I received the COVID Pfizer vaccine at Center on both Feb 17 and Mar 12. On April 6 I had leb tests performed by Quest Labs, and received the results on April 7.  My iron readings were quite low: Iron Total: 37 {normal range 50-180}, % Saturation: 13 {normal 20-48}; Ferritin 14 {normal 24- 380}. My last test prior was June 27, 2019 when the results were 76, 32 and 33 respectively.  Tomorrow I see my PCP physician and will discuss these results with him. My concern is that Ferritin, for example, is related to mRNA factors and the Pfizer CoViD vaccine is related to mRNA technology.  As I say, this is just preliminary prior to seeing my PCP, and he may wish to pursue this. I felt that I should let you know in case there are other vaccine / ferritin reports.
Fever up to 104, Chills, Body Ache, Left arm with approx 3 inch reddened raised welt type of area marked and noted to be painful and itchy.  Fevers started at approx 2230 and lasted until the next day. Alternating taking Tylenol and  Ibuprofen. Then fatigue and headache until approx 3 days later. My APRN was contacted on day 3 and told her about the symptoms and welt on the arm which appeared to have increased. Doxycycline 100mg started for possible cellulitis. As of today the left arm  no longer with large welt, but no size of bee sting and remains itchy.
65+ Fluad shot on Thursday afternoon 4:35pm.  Also got RSV in left arm at the same time.  On Friday, both shoulders were sore.  Late Friday, started to feel bad.  Came down w/ full blown flu symptoms - freezing and shaking all night, even though wearing a sweatshirt and under multiple blankets.  Dizzy when getting up and going to the bathroom.  Sweating at times.  Finally slept well from 6am to 10am on Saturday.  Felt tired w/ backache and headache all day Saturday.  Had a low fever, likely about 101F.  Went to bed 9pm Saturday and started the whole freezing/ shaking thing all over again.  Slept poorly again.  On sunday, sojewhat better but still tired and headache/ backache, though not as bad as on Saturday.
wound up with COVID 3 days later; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN), via an unspecified route of administration on 19Mar2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 22Mar2021, patient wound up with covid 3 days later the vaccination. The patient underwent lab test which included SARS-CoV-2 Test: Positive on 22Mar2021. The patient was due for her second dose on 16Apr2021 and is asking if she should continue or wait 90 days because she has been getting conflicting answers. The outcome of the event was unknown.   No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
After the second dose, I stopped having a menstrual cycle; After the second dose, I stopped having a menstrual cycle; This is a spontaneous report from a contactable consumer.   A 46-years-old female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 20Apr2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation.  The patient medical history and concomitant medications not reported. on 15May2021 the patient experienced after the second dose, i stopped having a menstrual cycle she taken several tests and she know it isn't due to pregnancy the patient underwent lab tests and procedures which included sars-cov-2 test: negative on 17Jul2021. Outcome of events was recovered with sequelae.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
pt recv vax & ran temp 105 very fussy & cried all the time (taken to hosp);pt given vax to counteract other one kept awhile for observation & released;
pt recvd vax & was found to be pregnant; LMP 16MAR92; 26DEC92 went into labor & devel hypertension; underwent a ceasarean section & gave birth to an 8lb 4 oz nl female;