chrisvoncsefalvay/vaers-outcomes huggingface dataset:
lypholized powder portion of the pentacel was given with sterile water instead of liquid dtap ipv that is provided as diluent/dtap ivp liquid was not administered/ no adverse event; Initial information received on 10-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 17.5 months old female patient who received lypholized powder portion of the pentacel with sterile water instead of liquid dtap ipv that was provided as diluent/dtap ivp liquid was not administered/ no adverse event, while she received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [Pentacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine conj 7v (crm197) (Prevnar) for Immunisation; and rotavirus vaccine live oral 1v (Rotarix) for Immunisation.  On 07-May-2019, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (ActHIB Lyophilized Powder. Lot: C5542AA exp date: 09-Aug-2019 ) via unknown route in the right vastus lateralis.  It was a case of actual medication error due to inappropriate reconstitution technique.  There were no side effects.  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.
Information has been received from the published literature article referring to a 26 year old female patient (patient# 2) with asthma. On an unknown date, the patient was vaccinated with a dose of PCV (manufacturer unknown) (dose, route and lot# were unknown) and a dose of influenza virus vaccine (unspecified) (dose, route and lot# were unknown). After vaccination, the patient experienced wheeze (bilateral), short of breath, heart rate increased, nasal congestion and nausea. The initial evaluation was performed in an emergency department and the emergency department doctor provided the diagnosis as vaccine-triggered anaphylaxis with Brighton level was 2. The patient was treated with nebulizer. Then on an unknown date, the patient recovered. Upon internal review, the event "vaccine-triggered anaphylaxis" was considered to be medically significant. This is one of several reports from the same source (1211USA007452, 0911USA01970, 1207USA012332, 1606USA012239, 1002USA01291, 1606USA012687, 1606USA012688, 1606USA012689, 1606USA012690, 1606USA012691, 1606USA012692, 1606USA012693). Additional information has been requested.
A small red spot appeared day 2.  By day 8 the spot was about an inch and a half to 2 inches in diameter.  It was red, raised, warm to touch and very itchy.  By day 10, the spot grew to about 3 inches and it was somewhat of a square shape.  By day 12, the swelling was gone and the spot was smaller but a little dark and flaky.   I have photos and I sent them to my doctor as well.
Arm soreness, muscle aches in upper body, chills, fatigue, and some Nausea
Bright red spot at the injection site; Itching; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Bright red spot at the injection site) and VACCINATION SITE PRURITUS (Itching) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) mRNA-1273. On 24-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (Bright red spot at the injection site) and VACCINATION SITE PRURITUS (Itching). At the time of the report, INJECTION SITE ERYTHEMA (Bright red spot at the injection site) and VACCINATION SITE PRURITUS (Itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Intermittent rapid heart rate; internal chills with normal temperature; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Intermittent rapid heart rate) and CHILLS (internal chills with normal temperature) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced HEART RATE INCREASED (Intermittent rapid heart rate) and CHILLS (internal chills with normal temperature). At the time of the report, HEART RATE INCREASED (Intermittent rapid heart rate) and CHILLS (internal chills with normal temperature) had not resolved.            No concomitant medications were provided.  No treatment was reported for the events.
Narrative:  COVID infection following COVID vaccine series 02/25, Pfizer, dose #1 03/18, Pfizer, dose #2 10/23/2020 Influenza administered 12/22/2020 COVID swab, result: detected 08/03 COVID swab, result: detected 08/04 pt cc: chills, cough, fever, rhinorrhea, sore throat exposure: " Was at restaurant: 08/05 pt cc: bilat eye redness, and itchiness for two days denies pain, loss of vision, trauma 08/06 pt cc: chills (improving), cough (improving), rhinorrhea (improving) "getting better" 08/07 pt cc: fatigue, fever (pt report temperature: 99.3) 08/08 pt cc: fatigue (improving), fever (improving), rhinorrhea (improving). 08/08 pt cc: possible bilat pink eye, sore eye, minimal drainage started (08/5) 08/09 pt cc: fatigue and rhinorrhea both improving 08/10 pt cc: no symptoms 08/10 clinically resolved 08/12 SARS-COV-2 Variant Sequencing result: pending
leaking when administered; leaking issue; Product Complaint; This case was reported by a nurse via call center representative and described the occurrence of incomplete dose administered in a patient who received DTPa (Reduced antigen) (Boostrix) (batch number 22MS7, expiry date 1st April 2024) for prophylaxis. This case was associated with a product complaint.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced incomplete dose administered, syringe connection issue and pharmaceutical product complaint. On an unknown date, the outcome of the incomplete dose administered, syringe connection issue and pharmaceutical product complaint were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 1-Jul-2022  Reporter's comment: The nurse from the clinic reported that 3 doses of Boostrix were leaking from the connection hub when administered to 3 different patients. The reporter was unable to confirm what type needle was attached to the syringe for the administration but stated that the luer lock device appeared to be attached crooked.  The content questions were asked as  where did the vaccine leak,  at the luer lock connection hub.  The syringe was not pre-assembled with needle some time before administration.  The size of gauge needle was uncertain.  The reporter will call back with additional information when she returns to the office.  The reporter believed it was 22G. Product quality complaint was filed. No blister and/or carton damaged.  No luer lock was damaged.  The needle used to administer was discarded in sharps container but the reporter will return an unused needle of the same type that was used during administration.  The reporter reported that she had emailed in pictures and might be attached to parent case.  The reporter was unable to provide GlaxoSmithKline information and will call back with information.  The reporter did not have specific patient identifiers.  No further information provided.  The consent to contact patient's health care professional unable to be obtained. Additional supportive information: The vaccine was leaking from the connection hub when administered to the patient which led to incomplete dose administered and syringe connection issue. The case was 1 of 3 linked cases. Follow-up request was raised for the patient's gender.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR104308:Same reporter US-GLAXOSMITHKLINE-US2022AMR104307:Same reporter
Symptoms started on the day of vaccination with a sore arm. The next day I was very tired and napped in the morning and the afternoon. This is very unusual. I had no appetite. That night I slept 10 hrs (I usually sleep 8). The next day I woke up feeling fine. The first dose of this vaccine was similar.
Fever, chills, body aches, pain on site, bruise on site after 2nd day.  slight dizziness , flushing and increased Heart rhythm on day log administration for about a minute and resolved. Have been having mild to moderate pain on right kidney area.
Patient received a vaccine that under went a temperature excursion; No adverse event; Patient received a vaccine that under went a temperature excursion; This spontaneous case was reported by a medical assistant and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient received a vaccine that under went a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received a vaccine that under went a temperature excursion) and NO ADVERSE EVENT (No adverse event) in a 4-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Aug-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received a vaccine that under went a temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received a vaccine that under went a temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient received a vaccine that under went a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received a vaccine that under went a temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (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 (Patient received a vaccine that under went a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received a vaccine that under went a temperature excursion).    No concomitant medication was reported by reporter.  Patient weight was reported as 36 (units not specified) Patient got 1st dose on LQ.  Some vaccines were stored in the freezer and other vials in the refrigerator. The excursion occurred on 7-Aug-2022 and was picked up by state review of the temperature data logger 2 weeks later after the excursion. Total 38 patients received this.  1 refrigerated vial was  with lot number AS1412B and expiration date 10-Feb-2023. Maximum or minimum temperatures reached was 14 degrees Celsius for 3hr 5min. Vial was moved from refrigerator on 8-Aug-2022. Those were administered or discarded. Proposed desired used by date was 18-Aug-2022. Vials were not punctured until they were used for the patient and then discarded.  No side effects were reported.  No treatment medication was reported by reporter.
At 09:40 attendee reported dizziness and shortness of breath and then fainted in the chair and slumped over. When she aroused about 10-15 seconds later, she had slurred speech, was cold and clammy, shortness of breath, and her respirations were tachypneic and labored. 09:45 - Lifted onto a cot that they brought to the area by her chair.  Almost seemed like she was drunk or having a stroke.  HR: 184  BP: 112/99 O2Sat%: 100.  10:05  Fainted 7+ times over 15 minutes, they were so busy caring for the attendee that EMS was not called, until now.   10:15 EMS arrived and took over care of the attendee. 10:23 EMS departed with attendee to the Emergency Room.
Site tenderness over right arm, immediately, post vax. Joint swelling and tenderness, within a couple of days, post vax. Pain in right elbow, soreness at right elbow, right hip and entire right leg and also pain at right knee and foot. Still have symptoms and are ongoing problems.
been vaccinated but still get them/Suspected vaccination failure; had them at least 4 times/still got them; Covid after 10 days; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included COVID-19 VACCINE (COVID-19 VACCINE BOOSTER) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine and the 2nd dose of COVID-19 VACCINE BOOSTER. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and covid-19. On an unknown date, the outcome of the vaccination failure and covid-19 were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and covid-19 to be related to Shingles vaccine.     Additional Information: GSK receipt date: 5-Sept-2022 Reporter's comment: The case was received from the patient via (Facebook) interactive digital media. The patient had been vaccinated but still got them. The patient have had them at least 4 times. The physician said that the patient might be in the 4 percent that just keeps getting them in spite of the vaccinations. The patient stated that they were not as bad as they were the first time. The patient had second Covid booster and got Covid 10 days later. Additional supportive information: It was unknown if the reporter considered shingles and covid to related to COVID-19 VACCINE BOOSTER. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. The case was linked with case US2022AMR129342, reported by same reporter. As per narrative it was clear whether Covid booster was taken prior to the vaccine or after that, therefore in worst approach Covid booster was also captured as suspect and covid event was also coded.; Sender's Comments:  US-GSK-US2022AMR129342:Same reporter
I had severe coldness, severe body aches where it hurt to move at all, severe vertigo to where just standing slowly made the room around me spin, severe migraine where it made my vision red, nausea and vomiting, fainting several times when attempting to go to the bathroom as slowly as possible, high fever of 101.9, swelling of the injection sight, and extreme fatigue
Information has been received from a nurse practitioner concerning a 20 year old female with gastric reflux who on 17-Oct-2006 was vaccinated IM with a first dose of Gardasil vaccine (yeast) (lot#653735/0688F). Concomitant therapy included Nuvaring and Aciphex. That evening the patient experienced quite a bit of nausea and a headache. It was noted that the patient couldn't study. On 18-Oct-2006, the nausea was gone. The patient thought that her headache was due to new contacts. On 19-Oct-2006, the patient's headache went away after she took her contacts out. One month later the patient experienced a upper respiratory infection but the nurse practitioner did not think it was related to the vaccine. Unspecified medical attention was sought. No diagnostic laboratory studies were involved. At the time of this report the outcome of upper respiratory infection was unknown. No product quality complaint was involved. Additional information has been requested. The patient stated that the nausea was a small price to pay for protection. On 18-Dec-2006, the patient was vaccinated into the left deltoid with a second dose of GARDASIL (lot# 654885/1424F). No product quality complaint was involved. Additional information is not expected.
Patient states excessive soreness in her arm, esp her shoulder joint. She needs APAP q4h for pain. Also, patient and caregiver is complaining of excessive bruising at/ all around injection site.  She states her whole upper arm is bruised.
All if the below began 10 hours after receiving 2nd dose vaccine. Nausea progressed to vomiting -let run course, drank fluids with electrolytes. Severe Chills- progressed to 103 °F fever- took tylenol Myalgia- tylenol, staying in bed Joint pain- same as above  Sweats- fluids, bed status  Arm soreness (at injectionsite)- tylenol  Headache- same as above  Bed-ridden currently. The only symptoms that have subsided: nausea/vomiting, chills/shakes
30 minutes, post vax, pt developed an allergic reaction with generalized pruritus. Treated with Benadryl as prn; no driving; no alcohol use while taking Benadryl and follow-up if symptoms worsen.
Got up the next morning after 1st vaccination with crusty eyes, itchy and watering.  Self care till sunday 3rd day went to UC.  Said I had pink eye.  Gave medication.  Later in the day started with fever, fatique, chills by day 5 after vaccination was told to get a Covid test which came back negative.  They felt I had a late immune response.  Was in good health for 2nd vaccination and the same thing happened with  my eyes.  Pink eye. We are 20 days out from 2nd vaccination and have pain in eyes, and watery.   Spoke with Opthamologist office and they suggested 1st I try Refresh for 2 weeks if my eyes are not better will need to be seen.  could be a response from the vaccine.
Patient began to get dizzy about 3 minutes after administration. Then began to feel nauseated, light-headed and shaky. Patient placed head between legs and a cold compress was applied to head and neck. Patient began to feel better after about 10 minutes and was observed for an additional 30 minutes. Patient left feeling normal.
Patient reports receiving 2nd dose of Moderna vaccine on 4/16/21. In the morning on 4/17/21 patient noticed a fist sized red area on her right arm beneath where she received the injection. Patient reports taking a shower and noticing that the area was larger later in the day. Client denies any pain, warmth, swelling, itching, discharge, or fever. Client denies any shortness of breath or difficulty breathing. Client advised to monitor the area and follow up with her provider if she develops any signs of infection, the area is getting larger, or it does not seem to be improving.
One week after the vaccine on 4/13, all of a sudden the vaccination site became red and raised. It was hive-like and the area felt tender and hard. The next day it was no longer raised but a bullseye rash remained about 3 inches in diameter. It is now 4/16 and the rash is still faintly there but it is fading and not as tender.
Patient received flu shot - within 10 minutes had itching on her lips. Pt closely observed and within next 5 minutes developed generalized itches; flushing and nausea. Pt taken to emergency department and was discharged the same day.
This case was reported by a consumer via call center representative and described the occurrence of injection site wheal in a female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (had five previous outbreaks of the shingles over the last 15 years). On 21st January 2019, the patient received the 1st dose of SHINGRIX. In January 2019, several hours after receiving SHINGRIX, the patient experienced injection site pain and injection site warmth. On 23rd January 2019, the patient experienced injection site wheal, shingles, injection site erythema and injection site hyperesthesia. On an unknown date, the outcome of the injection site wheal, shingles, injection site erythema, injection site pain, injection site warmth and injection site hyperesthesia were recovering/resolving. It was unknown if the reporter considered the injection site wheal, shingles, injection site erythema, injection site pain, injection site warmth and injection site hyperesthesia to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. At 1:00 pm, the patient received SHINGRIX in the left arm. Within a few hours of receiving the vaccine, the patient began to experience pain and heat at the injection site. Two days after receiving vaccination, the patient reported that she developed an outbreak of shingles in a 2 to 3 inch diameter around the injection site. The patient had raised whelps on either side of the injection site that were sensitive to touch and were painful. The patient reported that all symptoms were starting to resolve at the day of reporting. The reporter consented to follow up.
About 5 days after 3rd Anthrax shot, pt states that muscles around both eyes started twitching and also his lower right arm spasms periodically. Pt states that his hands grow weak from time to time & he is constantly fatigued.
Information has been received from a health professional who is the office manager concerning a 45 year old female who in October 2007, was vaccinated with Zostavax (Oka/Merck).  Secondary suspect therapy included Varivax (OKA/Merck) MSD.  The office manager reported that a patient was inadvertently given Zostavax instead of Varivax.  This was reported as a nursing error.  Additional information has been requested.
On the day of vaccination, I had a heavy menstrual cycle with extremely painful abdominal cramps. around 6:00 PM I noticed large blood clots with white tissue after wiping my perineal area. Today is day 5 after vaccination and I am still having a heavy menstrual cycle.   On day 2 following vaccination, I woke up with the same excruciating headache. Upon getting out of bed I suddenly felt very weak and nauseous. About 2 minutes later I experienced blurry vision, extreme diaphoresis, and my entire body was shaking. I believed I was going to faint so I sat down on the floor. My symptoms did not reside for 30 minutes.   From around 6:00 PM after Vaccination to today (day 5 after vaccination) I have has a persistent headache and I am still experiencing fatigue and malaise.
I started having breathing issues around 09/2022 and subsequently was in and out of my PCP office for several months. I was prescribed oral allergy medications and a steroid inhaler. I eventually saw an allergy/asthma doctor, after no improvement, and had breathing testing which indicated high levels of inflammation in my lungs.