chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a pharmacist and follow up information from a physician concerning a patient who received ZOSTAVAX and "broke out with full blown VZV". The physician stated that a 72 year old male patient with Lisinopril (manufacturer not reported) hypersensitivity and hypertension was vaccinated with ZOSTAVAX (lot #658859/0411X) in his left arm on 05-SEP-2008. Concomitant therapy included clonidine, simvastain (MSD), hydrochlorothiazide (+) Metoprolol Succinate, Omeprazole and Oxbutynin. 2 days after the vaccination, the patient experienced "small blisters" on his forearm and lower abdomen. The physician also stated that the patient experienced a headache and fatigue, but the patient was afebrile. The physician also stated that the patient's rash "looks like shingles". The symptoms were ongoing at the time of the report In follow up the physician also described the event as a rash with vesicular lesions occurring 3 days after vaccination. The patient had not had recent exposure to chickenpox or shingles. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine VZV strain. The sample of the lesion was collected on 12-SEP-2008. The sample was taken from a vesicular lesion. The PCR result for the specimen was inadequate specimen no strain identified. No further information is available.
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient's healthcare provider recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about November 2013, a pharmacist administered ZOSTAVAX, (lot# and route unknown) to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. On or about 18-NOV-2013, the patient was treated by a 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. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine. 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 include 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; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
Developed urticaria 2-3 d after receiving MENACTRA & GARDASIL vaccines.
Child went limp & had faroff stare; Pale, breathing-labored; Had rash over body; temp was 102.8 (ax); 25MAR91 sore throat & viral infect;
I began noticing that my arm was achy.  A soreness.  I thought it would go away in a few days.  A month went by and it hurt so bad that I went to dr.  They prescribed some strong ibuprofen and suggested I do some physical therapy.  Ibuprofen did not help the pain.  I did not do the therapy.  It lasted about 3 1/2 months before I began to feel better.
Within 5 minutes, flushed face, tightening of throat.  Then I experienced diaphoretic, itching, face swelling, wheezing, jerking movements (could have been from being cold, we don't really know why), nausea, slight cough.
24 hrs p/immun, urticarial rash appeared; Notable was that this was also approx 48hrs p/PCN & approx. 5 days p/viral tonsillitis;
Slight fever -- 100.9; extremely tired; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 77-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: Pfizer and expiration date: not reported), via an unspecified route of administration, administered in arm left on 27Feb2021 09:45 (at the age of 77 years) as single dose for covid-19 immunisation. Medical history was none. There were no concomitant medications (No other medications in two weeks). No other vaccine in four weeks, no covid prior vaccination and not covid tested post vaccination. No known allergies. Previously, patient received first dose of PFIZER-BIONTECH COVID-19 VACCINE (Solution for injection, Batch/Lot Number: EN6201 and expiration date: not reported), via an unspecified route of administration, administered in arm left on 06Feb2021 09:15 (at the age of 77 years) as single dose for covid-19 immunisation. The patient experienced slight fever - 100.9, was extremely tired and had diarrhea on 28Feb2021 at 06:00. No treatment given for any event. The patient's lab data included fever: 100.9. The Outcome of the events was recovered.  No follow-up attempts are needed. No further information is expected.
Felt sick after second shot; This is a spontaneous report from a non-contactable consumer. A male patient of unspecified age received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The medical history and concomitant medications were not reported. On an unknown date, after second shot, the patient felt sick. The clinical outcome of the event felt sick was unknown at the time of this report.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Initial report received from a health care professional on 29 Dec 2010: This patient was received a single dose of MENVEO (batch number: 100025) on 03 Sep 2010 and then received another dose (batch number: 100023) on 29 Dec 2010. No adverse events were reported. Follow-up report received from a health care professional on 04 Jan 2011: This patient was vaccinated with first dose of MENVEO (batch number 100025) at right arm deltoid on 03 Sep 2010 and second dose (batch number 100023) at left arm deltoid on 29 Dec 2010. On 29 Dec 2010, the patient presented site tenderness and the left deltoid achy. The event recovered on 31 Dec 2010. The events were reported as non-serious.
UrticariaPruritus Injection site discomfort, redness, itching, and swelling Narrative:
Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and FATIGUE (Fatigue) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 030L20A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: PREVNAR 13 (Allergy to Prevnar 13 causes swelling and rash). Concurrent medical conditions included Hypertension since 04-Sep-1998, Drug allergy (Lisinopril causes swelling), Shellfish allergy (Shellfish causes swelling) since 27-Jul-2017, Drug allergy (Amlodipine causes hives), Drug allergy (Polyethylene glycol causes hives, itching and swelling), Sulfonamide allergy (Sulfonamide antibiotics causes hives), Drug allergy (Augmentin causes hives), Drug allergy (Azithromycin causes hives), Drug allergy (Brimonidine Combigan  causes hives), Seafood allergy (Shrimp causes swelling), Food allergy (Oats causes hives), Drug allergy (Clindamycin causes facial rash), Drug allergy (Doxycycline causes hives and rash) and Drug allergy (Omnipaque Rediflo 240 causes oral contrast). Concomitant products included ATENOLOL, PRAVASTATIN, ACETYLSALICYLIC ACID (ASPIRIN 81), CALCIUM CARBONATE, COLECALCIFEROL (CALCIUM D3), LATANOPROST from 10-Sep-2020 to an unknown date, EPINEPHRINE (EPIPEN 2-PAK) and CETIRIZINE for an unknown indication.   On 25-Jan-2021 at 4:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021 at 4:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown.            No treatment medications were reported.   This case was linked to MOD-2021-029326 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Follow-up information received on 28-May-2021 contains Non-significant information.
Patient complained about a nodule that formed under the skin as well as pain in the injection site arm that lasted about a week and made it difficult to sleep on that side. No pain when awake and going through the day but when touching the area the patient reports pain.
No adverse events; medical assistant administered Moderna to a 17 year old. The vaccine is only approved for ages 18 and older.
PATIENT WAS GIVEN COVID-19 MODERNA BOOSTER INAPPROPRIATELY. PATIENT ONLY HAS 1 DOCUMENTED SERIES DOSE. NO TREATMENT NECESSARY, NO OUTCOMES OR SYMPTOMS OBSERVED
Itchy mouth, headache for 48 hours, low energy/generally felt unwell.
Patient was due for 5 tetanus and was given TDAP as Patient didn't need other components of DTAP vaccine was told by RN to give Adacel
patient report 'significant' GI illness including stomach cramping and diarrhea the evening after being vaccinated.
19DEC90 approx 415PM grunting, eyes rolled back, trembling all over, difficulty breathing, hot. Lasted approx 8 min. White blood count -good, temp 104, lt ear red.
Pt recvd 3 doses of Engerix-B vax on 11JAN90, 12FEB90, & 25JUL90 was found to be a non-responder;
5/12/08 parents allege that persistent reflux and discomfort date from RV given 4/10/08 started on PREVACID. Good weight gain. No disorder
Client's mom reports that approximately 1 week after vaccines were given on 11/25/19 that she noticed a discoloration on child's left thigh. Mom stated that child did not run a fever and had no signs of discomfort and no redness to area. Reports that after "a few days" she noticed an "indentation" on discolored area "especially when she stand up". Mom reported no other notable problems. Mom brought child back into clinic on 12-26-19 for evaluation. child was active and alert, standing and bouncing on mom's lap. Area on left leg noted to be slightly darker than surrounding skin. Approximately the size of a quarter, in an hour glass shape with notable indentation. Area is more in the middle of the front thigh area, not the vastus lateralus.  No redness or bruising present.
Uncontrollable tachycardia with palpitations and chest pain, intractable nausea, vomiting, and diarrhea; Tremors, dizziness.
I was 37 weeks at the time of my moderna vaccine with an estimated due date of 8/26/21. I was talking to the pharmacist and the room spinned around for a few seconds when I looked  straight. I was felt dizzy for a few seconds. Within 30 minutes and on and off throughout the first day I had heart palpitations. I rested when I got home which felt better for me. But after waking up the heart palpitations returned on and off. I'm on day 3 post vaccine and from day 2 until now I feel better. I just wanted to share my experience as a pregnant mom if it helps.
Dizziness/lightheaded, presyncope, and nausea that persisted for 48 hours
Received immunizations 10/12/04.  Mother noticed redness, swelling and rash around the site of DTaP on upper right thigh on 10/15/04.  She called the doctor who said to watch it and see him if increases.  Temperature 100.5 for two days after immunizations.  10/18/04 child okay, rash and redness gone.
Dizziness. From 02/20/2010 to Present (02/23/2010) still feel dizziness. Treatment: Intravenous Fluids, Meclizine
Vaccine went under temperature excursion; No adverse event; Vaccine went temperature excursion and was administered between 02-MAR-2023 to 28-MAR-2023.; This spontaneous case was reported by a consumer and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine went temperature excursion and was administered between 02-MAR-2023 to 28-MAR-2023.), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine went under temperature excursion) and NO ADVERSE EVENT (No adverse event) in an adult 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. 066H22A) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     In March 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In March 2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine went temperature excursion and was administered between 02-MAR-2023 to 28-MAR-2023.). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine went under temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine went temperature excursion and was administered between 02-MAR-2023 to 28-MAR-2023.), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine went under temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Vaccine went temperature excursion and was administered between 02-MAR-2023 to 28-MAR-2023.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine went under temperature excursion).    No concomitant information was reported. Suspect product dosage text was reported as unknown. It was reported that the day after power was lost in the middle of the day at 12:00 pm and had to placed all vaccine in a frozen bag. Booster vaccines were then transported to another clinic. No symptoms were reported. This case is reported for patient 5 out of 26 patients. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-718370 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718370:Master case
Information has been received from a medical assistant via Sanofi referring to an unspecified number of patients of unknown age and gender. The patient's concomitant medication, medical history and drug reactions/allergies were not reported. The reporter learned a delivery of vaccines including ROTATEQ was shipped on 11-AUG-2016 and received on 15-AUG-2016 which was too long in transit (outside PI storage). The reporter stated that 14 doses of ROTATEQ (lot # was reported as M004544, expiration date 18-OCT-2017 had been administered to patients orally since 15-AUG-2016. There was no further transport information, namely temperature. No adverse effects were reported. Additional information has been requested.
Rec'd vaccine on 10/17/07 at 10:45 am, at 6:50 PM that day (10/17/07) began with headache, body aches, joint pain, teeth pain, and nausea; injection site swollen (2" in diameter) and tender; felt feverish; felt the same on 10/18/07 and headache became migraine; migraine continued to 10/19/07 and resolved 10/19/07 PM.
Covid-19; Covid-19; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team. The reporter is the patient.  A 77-year-old male patient received BNT162b2 (BNT162B2), on 28Dec2020 at 09:00 as dose 1, single (Lot number: Ek9232), in left arm, on 14Jan2021 at 09:00 as dose 2, single (Lot number: Ek9231), in left arm, on 27Sep2021 at 13:00 as dose 3 (booster), single (Lot number: 301358a), in right arm and on 11Apr2022 at 16:30 as dose 4 (booster), single (Lot number: Fl9894), in left arm for COVID-19 immunization. The patient's relevant medical history included: "Htn" (unspecified if ongoing); "bph" (unspecified if ongoing); "elevated cholesterol" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL oral; FLOMAX [TAMSULOSIN HYDROCHLORIDE] oral; FINASTERIDE oral; VASOTEC [ENALAPRILAT]; ASA oral. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: previous pos; Negative; Positive, notes: antigen; Positive, notes: pcr. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient took oral Paxlovid for the treatment of COVID-19 started on 15May2022 and stopped on 20May2022.; Sender's Comments: The reported COVID-19 positive after both the doses of COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
patient fainting, we removed face mask to assure proper airway, applied cold rag to neck, keep in a laying down and then sitting position until the patient felt better then we moved to a chair
Case number PHEH2014US025132, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 74-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 11 Nov 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event was reported following this maladministration (incorrect storage of drug).
Nurse administered a Menveo vaccine by using different diluent than the approved; Nurse administered a Menveo vaccine by using different diluent than the approved; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA710A, expiry date 30th April 2023) for prophylaxis.   On 14th July 2022, the patient received Menveo. On 14th July 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 14-July-2022 Reporter's comment: The nurse administered a Menveo vaccine by using different diluent than the approved.  The reporter consented to follow up via mail. Additional supportive information: Menveo was reconstituted with different diluent than the approved was administered to the patient, which led to wrong solution used in drug reconstitution error and Inappropriate dose of vaccine administered.
2/13/04 Mom called our office-Had 2-3 small raised bumps on his back. No fever. 2/16/04 seen in office approximately 50 bumps abdomen, (sides and axilla on the Left). Playful. Afebril. 2/18/04 no new vesicles. Old vesicles scabbed over.
Patient was given an infant monovalent as the third vaccine instead of being given the infant bivalent vaccine as the third dose.
I had fever,body pains and sore arm for 2 days . Slight itchiness, rash started on 3rd day and started increasing with swollen face,  rash increasing and itchiness. Took OTC drugs for couple of days but didn?t help much. Visited the doctor and they prescribed steroids.
vaccination site bruise; itchiness; vaccination site redness; vaccination site swelling; pain in the injection site; pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain in the injection site), PAIN IN EXTREMITY (pain in arm), VACCINATION SITE ERYTHEMA (vaccination site redness), VACCINATION SITE SWELLING (vaccination site swelling) and CONTUSION (vaccination site bruise) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced VACCINATION SITE PAIN (pain in the injection site) and PAIN IN EXTREMITY (pain in arm). On 05-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (vaccination site redness) and VACCINATION SITE SWELLING (vaccination site swelling). On 08-Apr-2021, the patient experienced PRURITUS (itchiness). On an unknown date, the patient experienced CONTUSION (vaccination site bruise). At the time of the report, VACCINATION SITE PAIN (pain in the injection site), PAIN IN EXTREMITY (pain in arm), VACCINATION SITE ERYTHEMA (vaccination site redness), VACCINATION SITE SWELLING (vaccination site swelling), CONTUSION (vaccination site bruise) and PRURITUS (itchiness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient did not have any pre-existing medical condition includes and concomitant medication includes.
Patient had syncopal episode, urinated, became nauseous upon rousing. Placed in trendelenburg, left side lying for nausea. Patient bp 85/52, HR 110. Patient sent to ER via medics
This spontaneous report was received from a nurse practitioner and refers to a 23 year old female patient with none pertinent medical history, drug reactions or allergies. The patient's concurrent conditions were not reported. In approximately July 2015 (reported as 4 months ago), the patient was vaccinated by another healthcare provider with one dose of GARDASIL 9, (dose, route, anatomical location, lot number and expiration date were not reported). There was no concomitant medication reported. In approximately 2015 (reported as approximately 2 weeks post vaccination), the patient developed alopecia areata. The patient had been seen many specialists, dermatologist, rheumatologist and has had all types of testing, including DNA test on an unspecified date which the result was negative. It was reported that the patient spent thousands and thousands of dollars to resolve the issue. The patient was treated with an unspecified steroid injection to the head. The patient sought medical attention by contacting the nurse practitioner. The reporter nurse could not confirm if the patient was vaccinated with GARDASIL 9 or GARDASIL. At the time of the report, the outcome of the alopecia areata was recovering described as the patient's hair was starting to grow back (recovering). The reporter considered alopecia areata to be related to GARDASIL 9. Additional information has been requested.