chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a 55 years old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2014, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) for prophylaxis. As a result of her receipt of zoster vaccine live (ZOSTAVAX), in 2014, the patient was caused to suffer serious and dangerous side effects including shingles, including any and all of its sequelae, as well as other severe and personal injuries which were permanent and lasting in nature, physical pain and mental anguish. The patient was caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. As a direct consequence of zoster vaccine live (ZOSTAVAX), the patient also suffered other related health complications. In addition, the patient had required healthcare and services. The patient had incurred medical and related expenses. The patient also had suffered diminished capacity for the enjoyment of life, a diminished quality of life, increased risk of premature death, aggravation of preexisting conditions, activation of latent conditions, and other losses and damages. The outcome of the event was considered not recovered/not resolved. The event was considered related to zoster vaccine live (ZOSTAVAX).  The lawyer considered the event to be medically significant and disability.
4 days after the third dose , I have strong hives in my entire body legs, arms, belly and back. The hives didn't go way; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Jan2022 14:45 (Lot number: FL3209) at the age of 46 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Surgical menopause" (unspecified if ongoing); "hypercholesterolemia" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose Number: 1, Batch/Lot No: EL9261, Location of injection: Arm Left, MANUFACTURER UNKNOWN), administration date: 22Jan2021, when the patient was 46 years old, for Covid-19 immunization; Covid-19 vaccine (Dose Number: 2, Batch/Lot No: EN6203, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM, MANUFACTURER UNKNOWN, After the second dose I started to have sporadically. I thought that was some allergies. I went to the doctor,, did some exames and everything is normal.), administration date: 25Feb2021, when the patient was 46 years old, for Covid-19 immunization, reaction(s): "I started to have sporadically. I thought that was some allergies.". The following information was reported: URTICARIA (non-serious) with onset 18Jan2022, outcome "not recovered", described as "4 days after the third dose , I have strong hives in my entire body legs, arms, belly and back. The hives didn't go way". The event "4 days after the third dose , i have strong hives in my entire body legs, arms, belly and back. the hives didn't go way" was evaluated at the physician office visit. Therapeutic measures were taken as a result of urticaria.  Additional information: Vaccine facility type was hospital. Other vaccine in four weeks reported as no. 4 days after the third dose, patient had strong hives in her entire body: legs, arms, belly and back. The hives didn't go way. She searched and she found person with the same hives due vaccine allergies. Ae treated with Zyrtec. Covid prior vaccination and covid tested post vaccination reported as no. Patient had no known allergies.  Follow-up attempts are completed. No further information is expected.
Day after vaccination started getting bruises appearing.  Day 1 and 3 got red circular shaped rashes with pale centers. Got another bruise on day 4.  Wen tto ER where bloodwork was done.  Normal  1 week after vaccination hives started. Day 9 skin feels like it is burning in the sun.
Approximately 12 hours after receiving his second dose of anthrax vaccine the patient experienced chills, nausea, vomiting, diarrhea, dehydration and hypotension.  Patient was given three liters of IV normal saline and Reglan 10mg IV X 1 with improvement of symptoms. The follow up states the lot number is not known-pt was vaccinated at a military clinic.
Pt recvd vax 26FEB93 & devel pain in the rt bicep & tricep, pain in the bicep tendon; also devl sensation of weakness when used arm in specific ways; had fasciitis, swelling @ the inject site; grip strength of the rt arm was 30 pounds;
Large area of edema and erythema from shot site extending down arm 6-7". About 3.5" wide. Hot to touch and painful per patient. Raised from normal skin 1/2-1".
Information has been received from an administrator referring to unspecified patients of unknown age and gender. The patients' concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On unknown dates, the patients were vaccinated with RECOMBIVAX HB (intramuscular, newborn, 2month, 6month; strength, dose, batch/lot # and expiration date were not reported), ROTATEQ (oral, 2month, 4month, 6month; strength, dose, batch/lot # and expiration date were not reported) and GARDASIL 9 (intramuscular, two doses, six months apart; strength, dose, batch/lot # and expiration date were not reported) for prophylaxis. These vaccines were exposed to temperature excursion of 8.11 degrees Celsius to 9.09 degrees Celsius for unspecified duration. It was unspecified if there were previous excursions or not. It was unspecified if the call was because of a data logger. No adverse effect was reported.
pt recv vax 2MAY98 & pt recv vax & pt devel red bumps all over torso (shoulders to top of legs);pt was not treated for the event;
Moderna COVID-19 Vaccine EUA  rash at injection site; approximately 2.5 inches, itchy, red, hot, slightly raised; the rash appeared last night, 7 days after receiving the first dose of the moderna vaccine; there were no symptoms at the time of injection or afterwards until now.
This case was reported by a consumer via call center representative and described the occurrence of rash in a 69-year-old female patient who received SHINGRIX. Concomitant products included LAMICTAL, ZANTAC, MIRAPEX and trazodone. On 21st May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 22nd May 2018, 1 days after receiving SHINGRIX, the patient experienced fatigue and upset stomach. On 23rd May 2018, the patient experienced rash. On an unknown date, the patient experienced pruritus. On 23rd May 2018, the outcome of the fatigue and upset stomach were recovered/resolved. On an unknown date, the outcome of the rash and pruritus were unchanged. The reporter considered the rash, pruritus, fatigue and upset stomach to be related to SHINGRIX. Additional details were provided as follows: At 18:45, the patient received SHINGRIX on the left arm at 18:45. The patient experienced stomach sickness. Two days after vaccination, the patient stated she woke up with itching and rash on her trunk, chest and middle of waist. The reporter gave permission to contact her health care provider and provided contact details for the same.
The first day I received the vaccine on 3/5,  I was dizzy and tired and had arm pain. On 3/14 I noticed a raised red rash at the injection site size of  a palm of the hand. This morning  3/15 I feel nauseated, have a headache , fatigue and chills.
This spontaneous report was received from a medical assistant, concerning multiple patients of unknown ages and genders. The patients' medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored doses of PROQUAD, lot #N010865, expiration date 01-OCT-2018, albumin status of recombinant human albumin (rHA) (strength, dose, frequency and route of administration were not reported) and with improperly stored doses of VARIVAX, lot #M000997, expiration date 07-JAN-2018 (strength, dose, frequency and route of administration were not reported) for prophylaxis. The vaccines were reconstituted with a properly stored sterile diluent (lot # and expiration date were not reported). The temperature excursion was reported as 15 °F to 46 °F (23.4°F) for a time frame of 2 hours and 57 minutes. Previous temperature excursion was reported as 6 °F to 14 °F (13.4 °F) for 2 hours. Digital data logger was involved to capture the temperature excursions. No product quality complaint (PQC) was involved. Follow-up information was received on 24-JUL-2018. Additional information has been requested. This is non-valid report due to lack of patient identifiers. Follow-up information was received on 24-JUL-2018 from the medical assistant who provided patient identifiers for the reported event. The patient was a 5-year-old female child who on 28-FEB-2018 was vaccinated with improperly stored dose of PROQUAD lot #N010865 with the expiration date of 01-OCT-2018. At the time of the excursion, the vaccine was deemed stable. No adverse event was reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1712USA013102: US-009507513-1808USA001953: US-009507513-1807USA012551: US-009507513-1807USA012553: US-009507513-1807USA012554: US-009507513-1807USA012555.
No effects at the time vaccine received except a sore muscle in the arm for a few days.  Then yesterday, Jan. 15, a small red spot appeared at the injection site.  Itched some throughout the day and last night was a little larger--quarter size.  Itchy today and this evening  around 6 p.m. when I checked, it was larger-- silver dollar size and a little itchy.  No other symptoms.
SICK AS A DAMN DOG!!!! NON-STOP RACKING COUGH TILL MY THROAT WAS SORE AND RAW, UNABLE TO TALK AT ALL DUE TO SEVERE SORE THROAT, LOW GRADE FEVER, CHILLS, BODY ACHES, RUNNY NOSE. NON-STOP ILLNESS FOR 4-5 DAYS. UNABLE TO CONTINUE WITH DAILY ACTIVITIES OF WORK, HOUSE CLEANING, ETC. JUST LAID IN BED CONTINUOUSLY SICK AND REGRETTING THE DAY I EVER GOT THIS STINKING FLU SHOT!!!!
2/2/19 (evening) - pain in arm - chills - nauseousness. 2/3/19 (morning and day after) - chills, headache, body pain (severe) - sleepiness throughout the day.
Patient received a full dose of the Moderna vaccine (0.50) instead of the (0.25) half dose. Patient is not immunocompromised. Patient did not have any adverse reaction to the medication.
First approximately 5 hours after receiving vaccine, patient experienced headache and moderate to severe site pain. approximately 12 hours post vaccine, patient experienced nausea, dizziness, fatigue, headache. 3 hours following, patient continued to have the same symptoms along with mild shortness of breath and tachycardia with mild to moderate exertion, such as walking up a flight of stairs.
Information has been received from a physician concerning a 13 year old (previously reported as 11 year old) female with no pre-existing allergies, birth defects or medical condition and no illness at time of vaccination who on 20-FEB-1998 was vaccinated with a first dose of VARIVAX (Merck) (LOT# 623647/0802E) and on 12-OCT-2006 was vaccinated subcutaneously in left arm with a 0.5 ml second dose of VARIVAX (Merck) (LOT# 652630/0247F). On 06-APR-2008 the patient experienced a mild case of chickenpox. The rash appeared on the patient's trunk with different sizes and pruritus. It was noted that most of the lesion were papular. The patient did not have a fever. The patient treated with BENADRYL, calamine lotion and AVEENO as needed. On 16-APR-2008 the patient recovered from the events. The patient sought medical attention by having an office visit. There was no product quality complaint. Additional information is not expected.
This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 10Apr2021 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 62 years 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: "HTN" (unspecified if ongoing), notes: HTN; "High cholesterol" (unspecified if ongoing), notes: High cholesterol; "pre-diabetes" (unspecified if ongoing), notes: pre-diabetes; "glaucoma" (unspecified if ongoing); "known allergies crab" (unspecified if ongoing), notes: known allergies crab. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective and COVID-19 cannot be ruled out.
Vaccinator administered only 0.1 cc after realizing her mistake she gave 2nd vaccination  of 0.2 cc.
PENTACEL being administered as two separate doses. Caller states the DTap/IPV portion was administered to the patient, however it was not reconstituted with the ActHib lyophilized portion with no reported adverse event; Initial information received on 30-Oct-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 5 months old female patient who was being administered Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (VERO)] as two separate doses. caller states the dtap/ipv portion was administered to the patient, however it was not reconstituted with the acthib lyophilized portion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 20V (CRM197) (PREVNAR 20) for Immunisation.  On 30-Oct-2023, the patient received a 0.5 ml dose of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine Suspension for injection (lot UJ851AA, expiry date: 01-Apr-2024 with unknown strength) via intramuscular route in the thigh nos as Immunization as two separate doses. caller states the dtap/ipv portion was administered to the patient, however it was not reconstituted with the acthib lyophilized portion with no reported adverse event (single component of a two-component product administered) (Latency: same day).  It was reported "She would like to know if the lyophilized ActHib portion can be reconstituted with normal saline and administered to the patient? She would like to know if the 0.4% saline solution can be any they have on hand or does it have to be specific?"   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 the 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.
This case was reported by a nurse via sales rep and described the occurrence of myalgia in a 57-year-old male patient who received SHINGRIX for prophylaxis. On 3rd April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced myalgia and feeling unwell. On an unknown date, the outcome of the myalgia and feeling unwell were unknown. It was unknown if the reporter considered the myalgia and feeling unwell to be related to SHINGRIX. Additional details were provided as follows: The patient had a dose of SHINGRIX and experienced what he thought to be regular side effects, that is myalgia and not feeling. This case has been linked with case US2018GSK157614 (same patient) reported by the same reporter. The reporter agreed to be contacted for follow up.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Severe
Pt came for a booster after filling out paperwork for Pfizer and receiving vaccine nurse found out the patients first two vaccines were Moderna
Reported on 10/7/2020 with red raised rash and itching on arms abd and groin area with Prednisone 50 mg ordered with resolved issues as of 10/9/2020
Swelling of right deltoid following DTaP. Booster administration on 06/20/2002. Swelling noted on 06/21/2002 PM
Weird symmetrical pattern of wine-colored spots around vaccination site. No pain, no itching, flat, smooth surface.; This is a spontaneous report from a contactable consumer, the patient. A non-pregnant female patient of unknown age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 07Apr2021 at 15:45(at the age of 59-year-old) as a single dose for COVID-19 immunisation. Medical history included thrombosis leg and had mild allergy to some food products. Concomitant medications were not reported. The patient had mildly known allergy to some food products Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Apr2021, the patient experienced weird symmetrical pattern of wine colored spots around vaccination site. No pain, no itching, flat, smooth surface. The adverse event resulted in a visit to the doctors or other healthcare professional office/clinic visit, Therapeutic measures were not taken as a result of adverse events. The clinical outcome of the event weird symmetrical pattern of wine-colored spots around vaccination site was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
MILD CONFUSION; CAN NOT GET A THOUGHT TO GO OUT; SEVERE HEADACHE; NAUSEA; FATIGUE; DIZZINESS; VOMITING; BRAIN FOG; This spontaneous report received from a patient concerned a 65 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, expiry: UNKNOWN) dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the subject experienced brain fog. On 27-MAR-2021, the subject experienced dizziness. On 27-MAR-2021, the subject experienced vomiting. On 27-MAR-2021, the subject experienced severe headache. On 27-MAR-2021, the subject experienced nausea. On 27-MAR-2021, the subject experienced fatigue. On 28-MAR-2021, the subject experienced mild confusion. On 28-MAR-2021, the subject experienced can not get a thought to go out. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, vomiting, brain fog, mild confusion, can not get a thought to go out, severe headache, nausea, and fatigue on 2021. This report was non-serious.
rash on their upper arm, that got worse over the days, it was itchy, warm to the touch, achy; rash on their upper arm, that got worse over the days, it was itchy, warm to the touch, achy; rash on their upper arm, that got worse over the days, it was itchy, warm to the touch, achy; rash on their upper arm, that got worse over the days, it was itchy, warm to the touch, achy, and little swollen, and it spread to the lower forearm; rash on their upper arm, that got worse over the days, it was itchy, warm to the touch, achy; forehead was red very; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (forehead was red very), SKIN WARM (rash on their upper arm, that got worse over the days, it was itchy, warm to the touch, achy), PAIN (rash on their upper arm, that got worse over the days, it was itchy, warm to the touch, achy), PRURITUS (rash on their upper arm, that got worse over the days, it was itchy, warm to the touch, achy) and SWELLING (rash on their upper arm, that got worse over the days, it was itchy, warm to the touch, achy, and little swollen, and it spread to the lower forearm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMINS NOS for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced ERYTHEMA (forehead was red very). On 21-Feb-2021, the patient experienced SKIN WARM (rash on their upper arm, that got worse over the days, it was itchy, warm to the touch, achy), PAIN (rash on their upper arm, that got worse over the days, it was itchy, warm to the touch, achy), PRURITUS (rash on their upper arm, that got worse over the days, it was itchy, warm to the touch, achy), SWELLING (rash on their upper arm, that got worse over the days, it was itchy, warm to the touch, achy, and little swollen, and it spread to the lower forearm) and RASH (rash on their upper arm, that got worse over the days, it was itchy, warm to the touch, achy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, ERYTHEMA (forehead was red very), SKIN WARM (rash on their upper arm, that got worse over the days, it was itchy, warm to the touch, achy), PAIN (rash on their upper arm, that got worse over the days, it was itchy, warm to the touch, achy), PRURITUS (rash on their upper arm, that got worse over the days, it was itchy, warm to the touch, achy), SWELLING (rash on their upper arm, that got worse over the days, it was itchy, warm to the touch, achy, and little swollen, and it spread to the lower forearm) and RASH (rash on their upper arm, that got worse over the days, it was itchy, warm to the touch, achy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Patient was not told to keep the medication in the refrigerator. Will need to revaccinate according to the manufacturer.