chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient received expired bivalent booster after MFG expiration date; No Adverse Event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received expired bivalent booster after MFG expiration date) and NO ADVERSE EVENT (No Adverse Event) in an 11-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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 an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received expired bivalent booster after MFG expiration date) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received expired bivalent booster after MFG expiration date) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (patient received expired bivalent booster after MFG expiration date).    No concomitant information was reported. No treatment information was reported.
blochy face, inc in BP, rapid pulse, nausea, dry heaves; no local reaction;
Gave 0.5ml third full dose instead of half shot booster.; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (Gave 0.5ml third full dose instead of half shot booster.) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, the patient experienced ACCIDENTAL OVERDOSE (Gave 0.5ml third full dose instead of half shot booster.). On 02-Nov-2021, ACCIDENTAL OVERDOSE (Gave 0.5ml third full dose instead of half shot booster.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment medication reported.   This case was linked to MOD-2021-374517 (Patient Link).
Chills approximately two hours later. Lasted 2 days.  Extreme fatigue two hours later. Lasted 2 days. Arm soreness approximately 4 hours later, lasted 4 days. Reaction to bandaid used - irritated skin in shape of bandaid that still exists faintly. Extreme irritability for 3 days, could be unrelated but I could feel myself being irritable over things I normally wouldn?t be. It was the awareness that tipped me off to it being unusual than normal.
Information has been received from a nurse practitioner concerning a 37-year-old white female who in 2003 was vaccinated with a dose of VARIVAX (Oka/Merck). Subsequently, a titer did not show seroconversion. No other information was noted. Unspecified medical attention was sought. There was no product quality complaint. Follow-up information from the nurse practitioner indicated that the patient has received VARIVAX (Oka/Merck) two times and titers on 24-APR-2000 and 10-AUG-2005 have been negative. Additional information is not expected.
vaccines that are administered but have been deemed not suitable for use, the vaccines were on the truck on thursday but did not arrive to them until around 11 am / No AE; Initial information received on 24-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer (office staff).  This case is linked to cases 2019SA267341, 2019SA267342, 2019SA267344, 2019SA267345 and 2019SA267346 (same reporter).  This case involves a 89 years old female patient who received 0.5mL dose of vaccines INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] (lot UJ223AA, expiry-30-06-2020) via intramuscular route in the right deltoid.  It was a case an actual medication error due to incorrect product storage.  Caller is saying the vaccines were on the truck on Thursday but didn't arrive to them until around 11 AM but they did not hear until late in the day not to use them stating they received a message around 4:20 PM. Caller states as soon as they arrived she started giving injections and feels they should have been told earlier in the day that the vaccines shouldn't have been given.  At the time of report no adverse event was reported.  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 2001/83/EC and Module VI of the Good Pharmacovigilance 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.  List of documents held by sender: none.
PFIZER administered to 9 year old patient instead of Pfizer 5-11.
The patient called to complain of severe arm pain following the administration of his second dose of the vaccine.  He later was called and stated that he went to an urgent care, and the provider told him that they thought the vaccine may have aggravated his arthritis in his shoulder.
This spontaneous report as received from a pharmacist refers to a 62 year old female patient with asthma, depression, nasal congestion, and penicillins unspecified; sulfonamides-unspecified allergy. On 07-JUL-2015 the patient was vaccinated with ZOSTAVAX (lot # K016320, exp. date: 24-DEC-2015) 0.65 ml subcutaneous injection. Concomitant therapies included escitalopram, pravastatin and methylphenidate. On 09-JUL-2015, the patient experienced a mild reaction of five to six red-colored welts (urticaria), around injection site was itchy (injection site pruritus) and painful (injection site pain), but not terribly painful, after receiving ZOSTAVAX. The injection site had been weepy earlier but was no longer weepy. The patient sought medical attention and saw the pharmacist.  There was no intervention to prevent serious criteria. The events were not cancer,overdose, life threatening or caused significant disability or incapacity, hospitalization or prolongation. No PQC was involved. The outcome of the events urticaria,  injection site pruritus and injection site pain and the relatedness with ZOSTAVAX was unknown. Additional information has been requested.
Pt returned to the office 1 hour after the injection with a rash at the site of injection. Rash extended from wrist to shoulder on the left arm.
Hives, treated with Prelone and Benadryl and patient had low grade fever, generalized hives not the whole body.
1 week after getting the shot my left arm around the injection area became sore, red & hard. I went to urgent care & the said I have an infection at the injection site and gave me an antibiotic. It is a 5 day course
2 raised red hives on my arm below the vaccine injection site; Whole deltoid area was firm; Whole deltoid area was warm; Whole deltoid area was red; Bad pain in her armpit; armpit burning; Soreness at the injection site; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced multiple events of soreness at injection site, bad pain in her armpit, armpit felt full, armpit felt uncomfortable, armpit burning, armpit has achy feeling, whole deltoid area was red, whole deltoid area was warm, whole deltoid area was firm and 2 raised red hives on my arm below the vaccine injection site.   The patient's medical history was not provided. No concomitant medications were reported.  On 22 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot# 011J20A). On the same day, the patient experienced soreness at injection site. The treatment information included advil.   On 25 Dec 2020, the patient experienced bad pain in her armpit, armpit felt full, armpit felt uncomfortable, armpit burning, and armpit has achy feeling. No treatment information was reported.   On 29 Dec 2020, the patient experienced whole deltoid area was red, whole deltoid area was warm, and whole deltoid area was firm. No treatment information was reported.   On 30 Dec 2020, the patient experienced 2 raised red hives on my arm below the vaccine injection site. No treatment information was reported.   The Action taken with mRNA-1273 in response to the events was unknown.  The outcome for the event, soreness at injection site was considered as resolved on 24 Dec 2020.  The outcome for the events, bad pain in her armpit, armpit felt full, armpit felt uncomfortable and armpit has achy feeling was considered as resolved on 27 Dec 2020.  The outcome for the events, whole deltoid area was red, whole deltoid area was warm, and whole deltoid area was firm was considered as resolved on 30 Dec 2020.  The outcome for the events, armpit burning and 2 raised red hives on my arm below the vaccine injection site was considered as not recovered/not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Left arm felt scratchy; Left arm started immediately to swell up/arm has swelled to the size of a golf ball; Fever; This is a spontaneous case from reported by a pharmacist to agency (reference number: SEQ19-02940) and initially received on 19-Sep-2019, concerning a 54-year-old, female adult patient.  The patient's relevant medical history and concomitant medications were not provided.  On 18-Sep-2019, the patient was administered Flucelvax (QIV) [Influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, anatomical location: left deltoid, route of administration: intramuscular, batch number: 261207 and expiration date: 30-Jun-2020] for protection of influenza.  On the same day, after vaccination, the patient's left arm started immediately to swell up. Also, her arm felt scratchy and the band aid came off. The patient applied an ice pack and has taken Benadryl. As well, the patient mentioned that she may have had fever on the same day after injection. In addition, her left arm swelled to the size of a golf ball. Arm was bruised further the day after.  The outcome of the events was reported as unknown.  The case was assessed as non-serious and reporter did not provide causality to Flucelvax.  Follow up received on 02-Oct-2019: Patient's initials and information regarding patient's medical history and concomitant medications confirmed, outcome of the events updated. The narrative was updated accordingly.; Sender's Comments: Temporal relationship between administration of Flucelvax vaccine and development of adverse events is plausible. Combination of adverse events and its treatment with Benadryl may suggest hypersensitivity reaction. Based on the available information all adverse events were assessed as related to the suspect product.
entire torso rash from neck to thigh. It was itchy; entire torso rash from neck to thigh. It was itchy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 22Oct2021 16:45 (Lot number: Fh8020) at the age of 71 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Celiac" (unspecified if ongoing); "Colitis" (unspecified if ongoing); "allergy" (unspecified if ongoing), notes: Known Allergy : Yes. Concomitant medication(s) included: BUDESONIDE; ROSUVASTATIN CALCIUM. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL9264, Location of injection: Arm Right, Vaccine Administration Time: 10:00 PM), administration date: 02Feb2021, when the patient was 70 years old, for Covid- 19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6202, Location of injection: Arm Right, Vaccine Administration Time: 02:30 AM), administration date: 26Feb2021, when the patient was 71 years old, for Covid-19 immunization. The following information was reported: RASH (non-serious), RASH PRURITIC (non-serious) all with onset 24Oct2021 10:00, outcome "recovered" (26Oct2021) and all described as "entire torso rash from neck to thigh. It was itchy". Therapeutic measures were taken as a result of rash, rash pruritic.  Additional information: No other vaccine in four weeks was administered. Patient did not have COVID prior vaccination and COVID was not tested positive post vaccination. On 24Oct2021, entire torso rash from neck to thigh. It was itchy. Patient took Benadryl and it mostly went away after 48 hours, but was slightly itchy for a week.  No follow-up attempts are possible. No further information is expected.
Brain has been off.  Forgetful. Not sharp. Spacey. Foggy.  Multi-tasking diminished.  Speed and energy diminished. Always feel like I?m forgetting to do something. Things will be on the verge of remembering and then gone.
Upper right arm swelled like baseball beyond 48 hours and red rash blotches on upper arm.   Arm has been throbbing from shoulder to elbow
This spontaneous report was received from a physician via a company representative concerning to a patient of unknown age and gender. No concurrent conditions, medical history or concomitant medication were reported. On 08-OCT-2015, the patient was vaccinated with an improperly stored single dose of PNEUMOVAX 23 0.5 ml, which had a lot # L003188 and an expiration date of 06-JUL-2016 (route and anatomical location of administration were not reported). The sum of hours in excursion were 208, 200, 24 and 132 hours and the lowest recorded temperature reported were 29, 32, 33 and 34 Fahrenheit (F) (-1.666666667, 0, 0.555555556 and 1.11111111 Celsius (C)) respectively. The storage criteria and the storage type were reported as "Refrigerator(R)". The vaccine status was reported as "in excursion". No adverse effects were reported nor product Quality Complaint (PQC) was involved. This is one of several cases received from the same reporter. Additional information has been requested.
Petichiae on lower legs. Small, non blanching, non painful, not itchy, not raised red spots. Less than 5 on each leg.  I didn?t check my skin daily so they may have appeared earlier than May 25. I happen to wear compression knee stockings nearly every day.  As of today they are fading to light brown.   I would not have noticed them except my 94 year old mother, had many red dots covering her lower legs the day following her #4 Moderna vaccine. She had her #4 shot 2 months prior. She is on Eliquis. She does not wear compression stockings.
Nobody told me that I was going to have a hearing impairment.- Almost all my hearing is gone in my left ear; I have a little vertigo; But I already have a little imbalance thing already; second dose received on 16-Sep-2021, more than 35 days after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of HYPOACUSIS (Nobody told me that I was going to have a hearing impairment.- Almost all my hearing is gone in my left ear), VERTIGO (I have a little vertigo), BALANCE DISORDER (But I already have a little imbalance thing already) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose received on 16-Sep-2021, more than 35 days after 1st dose) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A and 040C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose received on 16-Sep-2021, more than 35 days after 1st dose). On 17-Sep-2021, the patient experienced HYPOACUSIS (Nobody told me that I was going to have a hearing impairment.- Almost all my hearing is gone in my left ear) and VERTIGO (I have a little vertigo). 17-Sep-2021, the patient experienced BALANCE DISORDER (But I already have a little imbalance thing already). At the time of the report, HYPOACUSIS (Nobody told me that I was going to have a hearing impairment.- Almost all my hearing is gone in my left ear), VERTIGO (I have a little vertigo), BALANCE DISORDER (But I already have a little imbalance thing already) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose received on 16-Sep-2021, more than 35 days after 1st dose) outcome was unknown.            No concomitant medications and treatment information reported.
Received COVID booster shot on 9/30/21. That afternoon, she had symptoms of severe abdominal pain, diarrhea, fatigue, and nausea. Reports abdominal symptoms were constant for 3 days them subsided. Fatigue and nausea continued, prompting visit to PCP on 10/13/21. Reports "sick sick feeling", nausea--can't tolerate zofran r/t constipation.  So eating raw ginger root. Feels clammy, hands are cold, no coughing, no pulmonary distress.  No pain.  At onset she had bad stomach pain and diarrhea x 3 days.  Stool has been nearly black but it's returned to normal again.  Back to regular stool habit--constipation from Zofran resolved.  Sleeping ok---sickening nausea awakens her at night but it's present all day long.  Feels like a freight train coming over her.  She is forcing herself to eat and drink fluids.  Same symptoms day after day.  Not increasing or decreasing.  No body aches.  Feeling nauseated.   Symptoms did not improve so patient presented to Emergency department on 10/16/21 complaining of generalized weakness and lethargy for past 16 days.   10/19/2021  Call from patient Patient called and wanted to let clinic know she is still sick. Has continued with  Fatigue/ malaise and  loss of appetite. Reports new additional symptoms of depression, insomnia, and new onset itching at the injection site. She states she did have a Rash around injection site that is still itching even though rash is no longer present, no appetite- has to make herself eat,  anxious, nausea, just overall feels weak, sickly, and starting to feel depressed.  She states she had a terrible experience at the ER and she did not get any answers.  10/20/2021 Call to  patient. She is still very weak.   She tried to get out of bed but had to get right back in it, due to the weakness. Her appetite is down.  11/4/2021  Call to  patient. States she's better -- not as weak; chills are gone..  Appetite is back.  But the anxiousness she's had all along is now much worse.  Sometimes she feels like curling up in a ball, so that's what she does. She reports she's had a lot of trauma in her past and used to have a lot of problem with severe anxiety.  But she hasn't had anything like this in years.  She doesn't want to take any medication for it. She remains hopeful that the improvement in her other symptoms is a sign that the anxiety will also resolve, as all the symptoms started within hours of #3 booster of her Covid vaccine. She has heard of another, patient, too, who had a similar reaction.  That makes her feel better, she states.   I assured her that I would pass her concern on to ID, who is tracking side effects of Covid vaccinations.  She states that would be appreciated.
Muscle and joint pain beginning 2 days after receiving the first shot. I have continued to have muscle and joint pain as of today - August 6, 2021, which is going on six months.
LOCALIZED SWELLING, REDNESS, WARM TO TOUCH, BRUISING FROM LEFT DELTOID, TRICEP, AND ALL THE WAY TO FINGERS. ALSO HAD NUMBNESS, TINGLING ON JOINTS AND FINGERS. PAIN TO TOUCH AND MOTION. FEVER AND MASSIVE HEADACHE. STARTED WITHIN 12 HOURS AND WORST AT 36 HOURS. AT 72 HOURS SWELLING, REDNESS, WARM AROUND THE AREA STILL PRESENTS. PATIENT WAS GIVEN ANTIBIOTICS AND SYMPTOMS STILL THE SAME.
Lethargy, substantial decreased eating - especially when trying to get her to eat, very pale in color. Eventually leading to breathing difficulties and death (one week from vaccinations). Starting the same afternoon of her vaccines, patient was very lethargic but fussy when awake. The next day and days to follow her eating substantially decreased and she was very pale in color. On February 2nd I noticed breathing changes, so I took her to the ER. She passed away at 68 days old on February 3rd. Now that I have done substantial research on adverse effects of vaccines, I know these vaccines had to do with her death.
Extreme chest pain, fever, dizziness, pulmonary embolism, hospitalization. No treatment was given at the hospital due to staff negligence. I left the hospital to take my own pain medicine since staff had me waiting for two hours and could not produce pain treatment during my time of need.
This spontaneous report received from a patient via a company representative 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 not reported, batch number: unknown and expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  In JUL-2021 (35 days prior to this report), the patient developed suspected Covid 19 infection (suspected clinical vaccination failure).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected Covid 19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000190332 This case is linked to 20210834870 (same reporter).; Sender's Comments: V0: 20210835180 -COVID-19 VACCINE AD26.COV2.S- suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS.