chrisvoncsefalvay/vaers-outcomes huggingface dataset:
internal bleeding; purple bruise on my left side on the skin of my left eye; rash all over my body; This is a spontaneous report from a contactable consumer.   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered on left arm on an unspecified date (Batch/Lot number was not reported) at single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient reported that she had a reaction to the first dose of Pfizer's COVID vaccine. She stated, "I had a reaction to the vaccine and developed a purple bruise on my left side on the skin of my left eye. I had the shot on my left arm. I described it like an 'old lady bruise'. It was very purple. I've never had this before. I called my doctor and she said it was some kind of internal bleeding. It wasn't large, but was a purple spot. She had sent me to the eye-doctor, even though it wasn't in my eye, but was close to my eye. I did go and see her, and a week later, she did say that there are some things with low platelets with vaccines, so she did to my blood work and checked some clotting things and everything seemed to come back fine. I did also get my antibodies checked. On day 16, I got my antibodies checked. They had a quantitative one and mine came back at 6.12. I did get a rash all over my body, but that may be from the sun because I do get a rash from being in the sun. I didn't know if it's not a good thing to get the second shot if I have a rash. Would I get that reaction and would it be worse the second time? " The outcome of the events was unknown.   No follow-up attempts are possible; information on the lot/batch number cannot be obtained.
Flublok was given to a 17 year old patient with no adverse event; Initial information regarding this valid unsolicited non-serious case from via Information (Reference number- 00309004) was received from nurse and transmitted to Sanofi on 09-Oct-2020.  This case involved a 17-year-old female patient received a 0.5 ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Lot number- UJ446AA, expiration date- 18-Mar-2021) via intramuscular route in the left arm for prophylactic vaccination (Product administered to patient of inappropriate age) on 05-Oct-2020.  The patient's medical history, medical treatments and family history were not provided.   No vaccination and concomitant medications were given.  It was actual medication error due to inappropriate age at vaccine administration (Latency: Same day).  At the time of reporting the patient did not experience any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Mother reporting.  He got his vaccine, and did fine yesterday.  He woke up his mother at 5:40, came to his mothers room and said that he was shaking, and mother noticed that he was, trembling.  She asked what was wrong and he said that he could not stop shaking and his chest was hurting.  She set him down in a chair and she got the autometer to check his BP and oxygen, and his BP was 134/98, and his 02 was 96, heart rate 86.  She felt him to see if he was having a fever, it was 98.4.  She told him to sit for a little while and waited about 10 minutes, she checked his BP again at 6:00 AM, and it was 139/102, he said that he was feeling really dizzy, his head started hurting real bad.  He said that he had a bad taste in his mouth.  She just monitored him, and his 02 was still 96, heart rate was still good.  He stayed in her room until 6:15 and she got up and told him if he got worse she would take him to the ER.  At 6:25 she gave him two 500 mg of Tylenol tablets and sat him in a recliner.  At 7:30 his head was still hurting, but he was not shaking, and she gave him some yogurt and water.  He stated that he started feeling better and around 7:40 he went back up to his room and went back to sleep.  He has been ok since then.
This spontaneous report as received from a physician assistant via company representative refers to a patient of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (dosing details were not reported). The reporter asked if there was any recommendations regarding revaccination if a patient received PNEUMOVAX 23 three months after receiving PREVNAR 13 or there was any information about adverse events occurring due to the patient receiving PNEUMOVAX 23 three months after receiving PREVNAR 13. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
large hive top of lt thigh-large red lump followed by small hives on both legs-circular rings, itchy;DPH given did not disappear until 5 days later;
Information has been received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medication were not reported. On 21-JUL-2016 the patient was vaccinated with improperly stored VARIVAX (lot # L042265, expiration date 26-OCT-2017, dose and route were not reported). The vaccine had been stored under temperature of 52.3 degree Fahrenheit for 11 hours. No previous excursions. No adverse effects were reported. This is one of three reports received from the same reporter. Additional information has been requested.
No adverse event; Pharmacist is calling to report that adult patient received expired first primary dose of Moderna COVID-19 vaccine; The vial was expired on 23-FEB-2023 and initially stored in the refrigerator on 02-MAR-2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacist is calling to report that adult patient received expired first primary dose of Moderna COVID-19 vaccine), PRODUCT STORAGE ERROR (The vial was expired on 23-FEB-2023 and initially stored in the refrigerator on 02-MAR-2023) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 052B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Mar-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 02-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacist is calling to report that adult patient received expired first primary dose of Moderna COVID-19 vaccine) and PRODUCT STORAGE ERROR (The vial was expired on 23-FEB-2023 and initially stored in the refrigerator on 02-MAR-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacist is calling to report that adult patient received expired first primary dose of Moderna COVID-19 vaccine), PRODUCT STORAGE ERROR (The vial was expired on 23-FEB-2023 and initially stored in the refrigerator on 02-MAR-2023) 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 (Pharmacist is calling to report that adult patient received expired first primary dose of Moderna COVID-19 vaccine) and PRODUCT STORAGE ERROR (The vial was expired on 23-FEB-2023 and initially stored in the refrigerator on 02-MAR-2023).    No concomitant medication was reported.    The vial did not undergo any temperature excursions. No treatment information was reported.   This case is for patient 1 of 2.   This case was linked to US-MODERNATX, INC.-MOD-2023-717206 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-717206:Patient No 02
Patient describes discomfort after the shot which continues to persist to present.  No bruising.  No neurologic deficits. Had a telehealth visit on 11/302020 and diagnosed with left arm pain due to trauma (vaccine), sent to physical therapy.
This spontaneous report was received from a pharmacist refers to a 68-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 24-OCT-2018, the patient was vaccinated with a dose of PNEUMOVAX 23 lot # R006466, expiration date 24-OCT-2019 (dose and route of administration were not reported) for prophylaxis (also reported as "over 65 years old"). The patient came to the pharmacy on 26-OCT-2018 and reported that on 25-OCT-2018, the patient experienced erythema, pain and swelling several inches below the injection site. The patient notified her healthcare professional (HCP) by phone on an unspecified date in October 2018 and no treatment was ordered. The outcome of the events was not reported. The relatedness between the events and PNEUMOVAX 23 was not reported.
This spontaneous report was received from a medical assistant concerning a 4 year old child patient of unknown gender. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On an unknown date in January 2018, the patient was vaccinated with improperly stored PROQUAD lot # N019248 and expiration date 20-DEC-2018 (strength, dose, frequency and route of administration were not reported) for prophylaxis. No adverse symptoms were reported. The temperature of excursion was reported as - 6.3 Celsius degrees during a time frame of 1 hour and 26 minutes on 02-JAN-2018. There was no previous temperature of excursion reported. There was a digital data logger involved. This is one among the several reports reported by the medical assistant. Sender's Comments: US-009507513-1801USA002808: US-009507513-1806USA010177: US-009507513-1806USA010178: US-009507513-1806USA010171: US-009507513-1806USA010180: US-009507513-1806USA010181: US-009507513-1806USA010176: US-009507513-1806USA010174: US-009507513-1806USA010173: US-009507513-1806USA010175.
Aches and pains all over; Fever; hands and feet keep locking up; sweated it out; Headache; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 73 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Nov2021 10:30 (Lot number: FJ1620) at the age of 73 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU VACCINE VII. Vaccination history included: Bnt162b2 (1st dose, Lot: EP7533, Expiry: Unknown, didn't have any issue with the 1st 2 doses, just a sore arm and was a little bit tired.), administration date: 23Apr2021, when the patient was 72 years old, for COVID-19 immunization, reaction(s): "sore arm"; Bnt162b2 (1st dose, Lot: EP7533, Expiry: Unknown, didn't have any issue with the 1st 2 doses, just a sore arm and was a little bit tired.), administration date: 23Apr2021, for COVID-19 immunization, reaction(s): "was a little bit tired."; Bnt162b2 (2nd dose, Lot: EW0158, Expiry: Unknown, didn't have any issue with the 1st 2 doses, just a sore arm and was a little bit tired.), administration date: 14May2021, when the patient was 72 years old, for COVID-19 immunization, reaction(s): "was a little bit tired.", "sore arm". The following information was reported: IMMUNISATION (non-serious) with onset 23Nov2021, outcome "unknown", described as "booster"; PAIN (non-serious) with onset 24Nov2021, outcome "not recovered", described as "Aches and pains all over"; HEADACHE (non-serious) with onset 23Nov2021, outcome "not recovered", described as "Headache"; PYREXIA (non-serious) with onset 24Nov2021, outcome "recovering", described as "Fever"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 24Nov2021, outcome "unknown", described as "hands and feet keep locking up"; HYPERHIDROSIS (non-serious) with onset 24Nov2021, outcome "unknown", described as "sweated it out". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain, headache, pyrexia, loss of personal independence in daily activities, hyperhidrosis. Additional information: Caller states that patient was calling her best friend who went to the hospital yesterday and got the Pfizer booster for Covid 19 vaccine, the adult dose. Ever since this morning her friend has just been laying around in bed, and experienced aches and pains all over, a headache, a fever of 100.8 which just broke and is now 98.1, and her hands and feet keep locking up, Caller states that patient has been giving her friend 2 Tylenol 500mg every 4 hours because she is not supposed to take Ibuprofen, but the patient already called her pharmacy and they told her that it was a side effect so she just wants to report it. She didn't have any issue with the 1st 2 doses, just a sore arm and was a little bit tired.   No follow-up attempts are possible. No further information is expected.
My COVID symptoms started the evening of the 09/07/2021 and I started feeling kind of wonky and I scheduled my appointment at the urgent care that evening for the next morning. On 09/08/2021 I had tested positive for COVID, and it was the worst head cold I've ever had as well as Sinus headache and congestion. That passed after 2-3 days and then I had a lot of coughing and tiredness for the next 4-5 days. Then on 09/27/2021 I went to the ER with a headache and high blood pressure and visual changes. They performed a CT scan and discovered that I developed a dissection of carotid artery. One of things that is a potential cause is coughing, and I did have a lot of coughing after covid. My blood pressure remained high and we are still working on that. I did spend two nights in the hospital to rule out stroke and blood clots and there was no evidence of that. Other than that I am still working with hospital and neurology to get my meds in order, and I am on blood thinners to prevent clots and to manage risk factors. I was prescribed albuterol for cough and Flovent (steroid inhaler).
On the first day I started feeling a sore throat on 04/24/2022. I started feeling more symptoms the next day of headache, body aches and chills. I had a very mild fever, highest of 101. The symptoms would come and go in waves. On the 10th day I was experiencing fatigue and sore throat.
A couple hours after I got the second vaccine, I started to feel a little soreness in my shoulder and clavicle area on the right side of my body. A couple hours after that I had lunch for about half and hour and as I got to getting up I started to feel a little dizziness and had general weakness in the knees and in joints of my thumb. Lower back pain and sweats as of me typing this in now.
Patient received an MMR II on 10/19/06. That evening he noted a area of rash or redness around the site of the injection. The rash gradually spread to his trunk, then down both arms, and then down his legs.The rash got much worse on 10/25/06. Advised by nurse to come in for eval. on 10/27/06. Macular-papular rash noted, small dots to large confluences/hives everywhere but neck and head. Itchy, red warm to touch.
Sever. Hills, nausea, muscle aches.  Felt like the worst case of flu ever. Had the adverse reactions for five days
Approximately 8 hours after vaccination reports ipsilateral tinnitus and burning sensation in left arm and left food. Has occurred episodically over the last 4 weeks. Also notes new onset fatigue, malaise, decreased appetite. Trial of prednisone with no improvement. Unclear if vaccination is related.
pt recv vax 16JUL98 & 23JUL98 devel fatigue & malaise;pt was seen in ER on 31JUL98 & advised to see a neurologist;
Child patient complained of racing heart beat on two occasions following the first vaccine dose of Pfiser Covid.  The first came at about four hours post injection and the second came at 40 hours post injection.  On both occasions, the symptoms were felt upon high physical activity.  The child was later tested with ekg and cardiogram, with no significant findings.  The child received his second dose more than four weeks later on December 10th and has not complained of symptoms.
dose given from vial that had been opened for 24 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose given from vial that had been opened for 24 hours) in a 51-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Jul-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose given from vial that had been opened for 24 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose given from vial that had been opened for 24 hours) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Looks to be a allergic reaction on both legs, blotchy red and purple almost bruise like all over both of my legs.
The Moderna vaccine was taken out of the freezer and placed in to the refrigerator on 9/8/2021. The vaccine was administered beyond the 30 days of which the vaccine is recommended to be kept in the refrigerator.  No adverse reaction occurred during the 30 minute waiting period or reported after the clinic date.
I had body aches and chills. Took Motrin 800 mg. Started at 830pm on 1/4/2021 and got better 1/6/2021
3RD PFIZER COVID VACCINE DOSE GIVEN 10/9/21 #FE3592; pt had a positive COVID test on 8/28/22; hospitalized on 9/22/22 with worsening SOB, COVID pneumonia; dc'd to SNF; 10/14/22 rehospitalized for SOB and hypoxia; O2 supplementation; AHRF; ICU; started on ABX and later stopped them due to lack of infectious bacterial pneumonia; placed on steroids and CellCept; DNR/DNI; pt transitioned to comfort measures; O2 supplementation removed and pt passed away in the hospital
I contracted COVID-19 on 07/16/2022 with symptoms of fever of 103.8 at highest point, sore throat, congestion, cough, chills, mild nausea, and fatigue. I was prescribed Paxlovid Renal Dose on 07/19/2022, and I experiencing a bitter metallic taste, and diarrhea while taking it. I was ill for 7 days before my symptoms began to resolve. I am fully recovered with no lingering symptoms.
Hives to bilateral arm, associated with mild-moderate itching. No SOB, no chest discomfort, no throat, tongue, swelling or hoarseness. Patient stated "I had a localized hive (right arm), when I got my first dose but it disappeared in a couple of minutes without any treatment". History of allergic reaction to "tramadol (breathing problem), benadryl usually helps" Benadryl administered, patient verbalized relief. Pt was advised to go to the nearest ER or call PCP if symptoms persist or get worse. V/S stable. Observation time extended for close monitoring. Family drove patient home in stable condition
Two days after the first vaccine dose I had a bad breakout of acne on my forehead, nose and chin. My cycle is currently over a week late.; My cycle is currently over a week late.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "known allergies: sulpha drugs" (unspecified if ongoing). There were no concomitant medications. The following information was reported: ACNE (non-serious) with onset 29May2021, outcome "unknown", described as "Two days after the first vaccine dose I had a bad breakout of acne on my forehead, nose and chin. My cycle is currently over a week late."; MENSTRUATION DELAYED (non-serious) with onset 29May2021, outcome "unknown", described as "My cycle is currently over a week late.". Therapeutic measures were not taken as a result of acne, menstruation delayed.  Additional information: Known allergies was reported Sulpha drugs. No other vaccine in four weeks patient had received. No other medications in two weeks patient had received. Patient received no COVID prior vaccination. Patient received no COVID tested post vaccination. It was reported that two days after the first vaccine dose she had a bad breakout of acne on her forehead, nose and chin. Her cycle was currently over a week late. Other side effects she was noticing the day after the second dose were joint and muscle pain.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from an other referring to a 13 year old patient of unknown gender. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 27-NOV-2017, the patient was vaccinated with improperly stored dose of VARIVAX injection (strength, dose, frequency and route were not reported) (lot # N020013 and expiry date: 17-JUL-2019) for prophylaxis. The administered dose of VARIVAX was reconstituted with properly stored sterile diluent (manufacturer unknown) (lot# and expiry date were not reported). The vaccine was stored in between -14 degrees Celsius (C) to -10 C (-14.37 C) for 15 minutes. There was no previous temperature excursion. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. There was no product quality complaint (PQC) reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1802USA008334.
Dizziness; Vertigo; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VERTIGO (Vertigo) and DIZZINESS (Dizziness) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 021C21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergic to Regulin) and Contrast media allergy (Allergic to some contrast dyes.).   On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Apr-2021, the patient experienced VERTIGO (Vertigo). On an unknown date, the patient experienced DIZZINESS (Dizziness). On 18-Apr-2021, VERTIGO (Vertigo) had resolved. At the time of the report, DIZZINESS (Dizziness) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: normal (normal) Found no abnormalities.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No treatment information was provided by the reporter.  Patient experienced the adverse reactions 15 days after the first and second dose of the vaccine. The patient went to the neurologist and underwent a CT scan.   This case was linked to MOD-2021-308538 (Patient Link).
PATIENT CONTACTED US ON 10/22/19 STATING HER ARM WAS RED, SWOLLEN (ABOUT SIZE OF PALM OF HAND). IT WAS RECOMMEND TO ICE IT, TAKE TYLENOL & CONTACT MD DR TREATED WITH BACTRIM DS FOR 5 DAYS