chrisvoncsefalvay/vaers-outcomes huggingface dataset:
HAV (VAQTA) on 2/20/03. Developed seizure afternoon on the same day. All lab tests (CSF, CT Scan) were negative. The follow up states HVA (VAQTA) on 2/20/03. Developed seizure afternoon on the same day. All lab test, CSF, CT scan were negative. Medical record states hypoxemia, vomiting, tremor. msv
Exactly 8 hours after I received my vaccine, I had bad shaking for approximately 2 hrs and I had periodic trouble breathing during the evening and early hours of the morning. I has a 101F fever. Today is day#3 after the vaccine and I still have nauseousness and no appetite.
a little sore arm; arm hurting, swollen; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (a little sore arm) and INJECTION SITE SWELLING (arm hurting, swollen) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) and DULAGLUTIDE (TRULICITY) for an unknown indication.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PAIN (a little sore arm) and INJECTION SITE SWELLING (arm hurting, swollen). At the time of the report, INJECTION SITE PAIN (a little sore arm) had not resolved and INJECTION SITE SWELLING (arm hurting, swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were provided by the reporter.
I believe the vaccine was administered incorrectly. The shot was very superficial, and did not feel like it entered my muscle. The pharmacist pinched my skin up prior to administering. I did not feel any pain in the moment, nor have I had any muscular sensations whatsoever since then. No bruising, stiffness, nothing of the sort as has been reported by others I know who have received the vaccine. I had no systemic reactions either, aside from a mild "buzz" in the first few minutes right after I received the vaccine. At first I thought the superficial administration was perhaps related to the brand. Most people I know have received the Moderna shot. I consulted CDC resources to find that all COVID vaccines are intramuscular, and that is where I realized I may have received it incorrectly. I understand per CDC guidance that another dose is not to be administered in replacement. I would like to know how or if the pharmacy will be alerted to this potential error, especially since I am scheduled to receive the second dose there later this month.
Initial unsolicited report received from a health care professional on 31 July 2015. A 50-year-old female patient, had received first dose of MENACTRA (batch number U4847BA, expiry date 03 March 2016, dose, dose number were not reported) intramuscularly in right deltoid on 27 July 2015 (08:00 Am). Pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as diabetes type 1, anemia, hypertension and penicillin allergy. Patient had no illness at time of vaccination. Any other vaccine within four week prior vaccinations were reported as none. Concomitant medications were Norvasc, lisinopril, PROTONIX, vitamin d and apidra. On 29 July 20155 (12:00 Pm); post vaccination, the patient experienced pain, headache and redness, swelling right arm and it was hot to touch. Patient had no laboratory investigations and corrective treatments were not reported. At the time of this report, the outcome of event was unknown. Documents held by sender: none. Follow-up information received from a health care professional on 19 August 2015. It was reported that no further treatment was given to the patient. As of 05 Aug 2015 the patient had recovered from the events "actual recovery date was not reported".
Patient reports swelling of the arm and a knot directly under the armpit happening about 6 hours after vaccine. She now has bruising down her side and at ribcage to bra level. She also had a mild fever after shot. Patient is reporting this 6 days later and still has moderate bruising as well as pain and swelling of the arm.
ACHES AND PAINS (MILD); This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: arthritis, alcohol use occasionally, non smoker, penicillin allergy, wheat products allergy, and drug allergy (T-dap, ilisone, codeine, flu-vaccine), and other pre-existing medical conditions included: The patient had no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1)(suspension for injection, route of admin not reported, and batch number: 203A21A expiry: 07-AUG-2021) dose was not reported, administered on 18-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-JUL-2021, the patient experienced aches and pains (mild).(Dose number in series 1) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aches and pains (mild) on 18-JUL-2021. This report was non-serious. This case, involving the same patient is linked to 20211258107.(Dose series in number 2 case) This case, from the same reporter is linked to 20211258945 and 20211258986.
rash throat small difficulty to swallow. she took Benadryl. she is fine. I told her to go to emergency.
3/16/17 - Patient started itching all over body, accompanied by fever, redness of skin at left thigh at injection site on exam - mild swelling and erythema (5 x 5 cm) at left thigh around the injection site (Lt. thigh).
Pt states his whole right arm was swollen red & sore from shoulder to finger tips.  Applied warm soaks with relief.  Slight swelling & redness still noted 10/27/08.
I have never had any type of rash in my life before. All of a sudden, I discovered small round patches on both arms, neck and chest. The doctor says its "pityriasis rosea". The cause is unknown and the only way I feel I would have gotten this is from the Moderna Vaccine.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20May2023 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with PAXLOVID from 16Sep2023 to 20Sep2023.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300314612 Same patient different drug/event;
vaccine doses were administered 20 days apart; chills; vomiting; This is a spontaneous report received from a non-contactable reporter consumer. The reporter is the patient.  A 74-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in the left arm, administration date 25Feb2021 10:30 (Lot number: Em6198) as dose 2, single for COVID-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing). Concomitant medications included: ATENOLOL; ROSUVASTATIN; VITAMIN C [ASCORBIC ACID]; FLOMAX [TAMSULOSIN HYDROCHLORIDE]. Vaccination history included: BNT162B2 (dose 1, administered in the left arm, Lot number: EM9810), administration date: 06Feb2021 15:15, for COVID-19 immunisation. The following information was reported: CHILLS (non-serious) with onset 25Feb2021 23:45, outcome "recovered" (26Feb2021 11:45), described as "chills"; VOMITING (non-serious) with onset 25Feb2021 23:45, outcome "recovered" (Feb2021), described as "vomiting"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "vaccine doses were administered 20 days apart". Therapeutic measures were taken as a result of chills, vomiting.  Additional information: Therapeutic measures included naproxen sodium (ALEVE) and went to bed. The patient was not diagnosed with COVID-19 prior to vaccination, and he has not been tested for COVID-19 since the vaccination. He did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient has no known allergies.  No follow-up attempts are needed. No further information is expected.
Multiple erythematous vesiculopapular eruptions over arms, hands, legs, heels, chest, upper back, upper trunk, onset 17 days following receipt of SPV, HEPB#1, AVA#1, TYPHOID vaccines; initially mildly pruritic, then became painful; no fever/chills or other significant symptoms; initial derm evaluation 2/4/2009 yielded prelim dx dermatitis with DDX to include hypersensitivity reaction to SMALLPOX vaccine, HSV, VZV, less likely generalized vaccinia; initially prescribed VALTREX; on 2/9/2009 oral steroids with taper was prescribed with fairly rapid improvement of tenderness and gradual crusting of all vesicles; labs & tissue biopsies ruled out viral etiologies; delayed hypersensitivity reaction was included in differential. VHC recommended medical temporary vaccine exemptions for both ANTHRAX & HEPB vaccinations to be given approx 4 weeks after completion of oral steroids, singly a week apart, & only if skin lesions fully resolved without recurrence; and medical reactive exemption for SMALLPOX vaccine.
First 36 hours  - Vomiting and choking while vomiting (difficulty breathing, more than normal during vomiting), high fever (104°) and fever (100°+) for 36 hours, fever chills, body aches, body soreness, sharp headache, and fatigue. Treated with alternating aspirin and acetaminophen every two hours, which did not bring down the fever below 100° for the first 36 hours.  Following 36 hours - Nausea, diarrhea, sweating but no fever, difficulty breathing, coughing, and chest pressure. Treated with occasional acetaminophen as needed.
This case is a part of a cluster of 3 cases and is linked to 2012-10348 and 2012-10322 (reported by same reporter, after FLUZONE ID batch - number UT4472AA). Initial report received from a healthcare professional on 01 November 2012. A female patient, whose age, medical history and concomitant medications were not reported, had received an intradermal dose of FLUZONE ID (batch number UT4472AA, site of administration was not reported) on an unspecified date. On an unspecified date, after vaccination, the patient experienced warmth, swelling and trouble lifting arm. Corrective treatment and laboratory details were not reported. At the time of this report, the outcome was not reported. Follow up information received from a healthcare professional on 25 March 2013. Patient's age at the time of event was reported as 52 years. The patient had no significant medical history or illness at the time of vaccination. The patient was vaccinated on 23 October 2012 in the right arm. The event start date was reported as 24 October 2012. The patient applied warm compresses and had taken MOTRIN as corrective treatment. The patient had recovered from the event after approximately 5 days. Document held by the sender: Consent for Influenza vaccine.
Information has been received from a physician concerning a 68 year old female with a history of multiple allergies and one time vaccination with Pneumococcal 23v polysaccharide vaccine who was vaccinated (date not provided) with a dose of Pneumococcal 23v polysaccharide vaccine (lot 651318/1005). Subsequently the pt developed pain, redness and swelling at the injection site extending into axillary region and posterior cervical area on same side. The pt was treated with cephalexin (Keflex). The pts outcome was not reported. There was no product quality complaint involved. The physician also provided information regarding another pts experience with Pneumococcal 23v polysaccharide vaccine (WAES0510USA07275, WAES0510USA08240. Additional information has been requested.
tested positive for Covid; tested positive for Covid; fever of 102; really bad congestion; cough; a feeling of crystalized snot in the back of her throat; didnt feel good; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on May2021 (Batch/Lot number was not reported) as single dose, dose 1 via an unspecified route of administration on Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. Two days before (06Oct2021), patient was tested positive for COVID, a fever of 102, really bad congestion and cough, a feeling of crystalized snot in the back of her throat, and just didn't feel good. She started feeling better yesterday but then had a low fever this morning (08Oct2021). Outcome of fever was not resolved. Outcome of other events was resolving.  The lot number for the vaccine [BNT162B2], was not provided and will be requested during follow up.
Case number PHEH2016US021750, is an initial spontaneous report received from a nurse on 25 Aug 2016. This report refers to a patient of an unknown age and unknown gender. Medical history was not reported. Concomitant medication was not reported. The patient received FLUVIRIN (batch number not reported) at a dose of 0.1 ml (underdose) on 25 Aug 2016. The patient was administered underdose. No adverse event was reported following the maladministration (vaccine underdose).
No adverse effects reported; a patient received unspecified dose of PEDV AXHIB that was improperly stored/experienced excursion; This spontaneous report was received from a nurse, concerning a patient of an unknown age and gender. The patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications were not reported.   On 05-AUG-2019 the patient was vaccinated with an improperly stored (product storage error),dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) lot number N003536, expiration date 02-NOV-2019, (strength, dose, frequency, route of administration and anatomical location were not reported) for prophylaxis.    The vaccine was stored at the temperature of 8.72 degrees Celsius for the time frame of 1 hour and 35 minutes. Previous temperature excursions were reported as (more than 1), the call was because of a data logger. No adverse effects were reported.
Information has been received from a nurse referring to 2 patients of unknown age and gender. On 07-OCT-2015 the patients were vaccinated with improperly stored ZOSTAVAX injection (lot # L007222, expiration date 03-JUN-2016) (dose and route were not reported). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
left shoulder is warm at the injection site; left shoulder is a little sore at the injection site; left arm swollen; if she picks up her left arm it's sore; received booster dose; received booster dose; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 99-years-old female patient received third dose of the BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in arm left on 15 Sep2021 11:00 (at the age of 99 years-old) as dose 3, single for COVID-19 immunization. Medical history included staph infection from 2005 to an unknown date. When probing medical history, she states she had never had anything serious happen to her except one time she had a staph infection that was pretty serious. She had taken a trip and 2-3 weeks after returning home she developed the staph infection. She was really sick. patient had not received any other vaccine within 4 weeks. Patient was not pregnant at time of vaccination. The patient's concomitant medications were not reported. When probing concomitant medications, she states she didn't think her medications are relevant. The patient previously received dose (first and second) of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) in right arm on an unknown date in Jan2021 as single dose for COVID-19 immunization. The patient stated that first doses were given in her right arm, and she had no reaction at all from the first 2 doses. She didn't even believe she had the first 2 doses because she felt nothing. Clarified she had no reaction to the first 2 doses. She was calling about the booster shot. She just got her booster dose on Friday 10Sep2021. She reported that today is 15Sep2021, her shoulder is warm and a little sore and it had been sore but today it got very warm at the injection site. It's warm and sore, it's not terrible but she thought she should call. She states she woke up today and her left arm is warm and swollen and if she picks up her left arm it's sore. On 15Sep2021, the patient experienced left shoulder is warm at the injection site, left shoulder is a little sore at the injection site, left arm swollen, if she picks up her left arm it's sore, received booster dose. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The outcome of the events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
pt recv vax 10MAR98 & 13MAR98 T101, fussy,loose stools;16MAR98 itchy, bumpy red rash, rotovirus, cold agglutinins nl;
This spontaneous report as received from a registered nurse via a company representative refers to a male patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX, one single short, subcutaneous, (lot# and dose unspecified) for treatment of shingles. On an unknown date the patient presented with flu like symptoms: fever, chills, and body aches. The patient did not seek medical attention and no treatment was given for the events. No lab diagnostics studies performed. The outcome of the events was unknown. Additional information is not expected as the reporter did not want to be contacted.
On 3/18/21 patient signed a consent stating she had not received a vaccine yet and desired to receive one during this clinics vaccination days. On 4/8/21 this patient was given what was thought to be her first Pfizer COVID vaccine. The facility later received notification from the nursing home that this patient  received both doses of vaccine in January. The patient stated she did not know what she received at the nursing home. No adverse reactions noted.   1/8/21, 10:00, Lot # EH989, Pfizer, R deltoid 1/29/21, 1030, Lot # EN5318 Pfizer, R deltoid
Yesterday pt reported sore arm, swollen/red arm, body aches, fever (102F), headache, difficulty swallowing, palpitations, shortness of breath, gets winded walking around. This was when she spoke to triage nurse. Advised to go to Urgent Care or ED and follow up with PCP Dr.
reaction; This case was reported by a nurse via patient support programs and described the occurrence of adverse drug reaction in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2018-2019 season) for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent 2018-2019 season at an unknown dose. On an unknown date, unknown after receiving FluLaval Quadrivalent 2018-2019 season, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown.   It was unknown if the reporter considered the adverse drug reaction to be related to FluLaval Quadrivalent 2018-2019 season.  Additional details were received as follows: The age at vaccination was not reported. The reporter called requesting 2018 insert for the Flulaval quad pfs product. The reporter stated that the patient had a reaction to the product and the patients mother was looking to receive the insert.
she got tested and the platelets were low after her first dose of the Moderna Covid19 Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PLATELET COUNT DECREASED (she got tested and the platelets were low after her first dose of the Moderna Covid19 Vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PLATELET COUNT DECREASED (she got tested and the platelets were low after her first dose of the Moderna Covid19 Vaccine). At the time of the report, PLATELET COUNT DECREASED (she got tested and the platelets were low after her first dose of the Moderna Covid19 Vaccine) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       No concomitant medication information was provided. The patient got a waiver pass or whatever from the doctor, that said that she didn't have to get the second one. No treatment medication information was provided. Caller mentioned that she is not the only one who got this, and when clarified if she knew someone who experienced this, she stated that her sister is a nurse, and she got tested and the platelets were low after her first dose of the Moderna Covid19 Vaccine.; Sender's Comments: This case concerns an unknown age, female patient with no relevant medical history, who experienced the unexpected event of platelet count decreased. The event occurred after the first dose of Spikevax (mRNA 1273 vaccine). The rechallenge was not applicable since only information about one dose was disclosed. The causality was not reported by the reporter. The benefit-risk relationship of Spikevax vaccine is not affected by this report.
1st dose 2 years ago, 2nd not received; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose approximately 2 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 18-JAN-2023 Reporter's comment: The reporter was patient's wife. She stated that her husband received his first dose of Shingrix approximately 2 years ago but was not received his second dose.  The reporter did not consent to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.