chrisvoncsefalvay/vaers-outcomes huggingface dataset:
given Pediarix after being frozen .; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 6-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number Z4R9R, expiry date 14th May 2023) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd November 2021, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The nurse given Pediarix after being frozen at minus 0.45 Celsius for 15 minutes to the patient, which led to incorrect storage of drug. The reporter consented to follow up. This case was 1 of 10 linked cases, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021230181:same reporter US-GLAXOSMITHKLINE-US2021230192:same reporter US-GLAXOSMITHKLINE-US2021230173:same reporter US-GLAXOSMITHKLINE-US2021230191:same reporter US-GLAXOSMITHKLINE-US2021230195:same reporter US-GLAXOSMITHKLINE-US2021230188:same reporter US-GLAXOSMITHKLINE-US2021230177:same reporter US-GLAXOSMITHKLINE-US2021230178:same reporter US-GLAXOSMITHKLINE-US2021230180:same reporter US-GLAXOSMITHKLINE-US2021AMR231962:same reporter (master case)
December 22, 2022 I had no symptoms. I had a physical. I received the results of bloodwork I had the week before. The results showed Hemoglobin count was off at 10.2 which is low. I had more bloodwork to look at iron that day. I was diagnosed with anemia. I started taking iron supplements. I had an appointment with a GI on 1/10/22. I had an appointment with a Hematologist on 2/2/2023 who confirmed my diagnosis. He did more bloodwork and my iron had improved some after beginning iron. I am having more follow up tests to check for internal bleeding.
My first vaccine dose was on 1/28/2021 and my second vaccine dose was on 2/25/2021, so facility for both shots. Same area of the left arm (south of the ball of the shoulder). For my first shot I had more than the usual soreness in the arm at the injection site but it seemed to subside as I got closer to getting my second vaccine dose. After the second dose, I had several more side effects including arm soreness at the injection site, but the majority of the side effects subsided within 2-3 days. My arm is still sore in the same area. It is more evident when I raise it up toward my head either to prop it up while sitting on the sofa or to cover my eyes when laying down. It is also more noticable when I use it often to carry things like groceries or have it bent during the day at my computer typing.  It will get better with some rest but the ache will still be there.
swelling around the injection site, about 3 inches; redness around the injection site, about 3 inches; tenderness around the injection site, about 3 inches; Headache; Body ache; Chills; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (swelling around the injection site, about 3 inches), INJECTION SITE ERYTHEMA (redness around the injection site, about 3 inches), VACCINATION SITE PAIN (tenderness around the injection site, about 3 inches), HEADACHE (Headache) and MYALGIA (Body ache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INJECTION SITE SWELLING (swelling around the injection site, about 3 inches), INJECTION SITE ERYTHEMA (redness around the injection site, about 3 inches), VACCINATION SITE PAIN (tenderness around the injection site, about 3 inches), HEADACHE (Headache), MYALGIA (Body ache), CHILLS (Chills) and PYREXIA (Low grade fever). At the time of the report, INJECTION SITE SWELLING (swelling around the injection site, about 3 inches), INJECTION SITE ERYTHEMA (redness around the injection site, about 3 inches), VACCINATION SITE PAIN (tenderness around the injection site, about 3 inches), HEADACHE (Headache), MYALGIA (Body ache), CHILLS (Chills) and PYREXIA (Low grade fever) outcome was unknown.            Treatment included Ice pack. No relevant concomitant medications were reported.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded.   This case was linked to MOD-2021-018959 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded.
Temperature excursion that was intermittent; This spontaneous report was received from a registered nurse, concerning a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications were not reported.   Since 27-JUL-2020, varicella virus vaccine live (oka/merck)(VARIVAX) were improperly stored and had temperature excursions.   On 24-AUG-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 ml for prophylaxis, lot #T002843 (also reported as TOO2843) and expiration date reported as 23-JAN-2022) (strength, frequency and route of administration were not reported)  The temperature excursion was reported from -14°C to -10°C (max -9.5°C), during a time frame of 38 hours and 30 minutes. There was previous temperature excursion.   A digital data logger was involved.
Information has been received from a health professional concerning a 6 year old male with no known medical history or allergies who at one year of age on approximately 2/11/2000 was vaccinated with a dose of varicella virus vaccine live. On 5/30/2005 the patient presented to the clinic with a mild case of chickenpox breakthrough. Unspecified medical attention was sought. There was no treatment. Subsequently, the patient recovered. There was no product quality complaint involved. Addition information has been requested.
Information has been received from a case in litigation concerning an approximately 6 month old female who on 26-MAR-2001 was vaccinated with a dose of PEDVAXHIB and a dose of DTaP during a six month check up. It was reported that the patient experienced seizure symptoms 2 or 3 days after the vaccinations. On 14-APR-2001 the patient's parents brought her to an emergency department, reporting that she had stopped breathing for five minutes. They reported two previous episodes, which took to mean between 08-APR-2001 and 14-APR-2001. Upon internal review, seizure symptoms and stopped breathing for five minutes were considered other important medical events. No further information is available.
Herpes zoster attack.  None prior.  No other known  causes.  Treatment valacyclovir orally 1000 mgm a 8h,  acyclovir topically,  oral analgesics, topical otc meds
Received second dose of shingles (SHINGRIX) about 3pm on Monday 11/12/18 at doctor's office. Awoke early in the morning on 11/13/18 about 2am to use the restroom. Upon attempting to return to bed had severe dizziness, nausea, fading vision and eventually lost consciousness and fell. Awoke about 5 minutes later (per partner) still dizzy, nauseated, cold and clammy. Was able to get up (on own) and back in bed in about 20 minutes or so. Remained shaky, dizzy and nauseous until Tuesday afternoon when those symptoms resolved, approximately 24 hours after the vaccine was administered. Remained sore due to fall but was able to go to work on Wednesday with no lingering dizziness and no other lack of consciousness. No other symptoms such as vomiting and diarrhea were experienced at any time. Unable to identify any other cause for reaction. No issues with 1st dose of SHINGRIX.
Bell?s palsy to right side of face. Onset 3/10/21   Numbness and tingling, slight drooping of right corner of mouth. 3/11/21  right side of face looks like it had melted. Went to ER for neuro exam and work up. Heavy steroids and anti virals given. On 3/11/21 after a video consult. 4/23/21 90% recovery of facial muscles. 4/30/21 full usage back.
-unusual pain immediately after injection -pain persisted for 3 weeks, noted @ ROM -denies N/T and weakness -per patient palpable nodule
Tested positive for Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for Covid-19) in a 64-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No recorded medical history).    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced COVID-19 (Tested positive for Covid-19). At the time of the report, COVID-19 (Tested positive for Covid-19) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment for the event included monoclonal antibody therapy.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 74-year-old female patient who received SHINGRIX (batch number 9YD45, expiry date 2nd February 2021) for prophylaxis. On 20th July 2018, the patient received the 1st dose of SHINGRIX .5 ml. In July 2018, less than a week after receiving SHINGRIX, the patient experienced injection site swelling, injection site pain, injection site erythema and injection site inflammation. On 23rd July 2018, the patient experienced abdominal pain and ankle swelling. On an unknown date, the outcome of the injection site swelling, injection site pain, injection site erythema, injection site inflammation, abdominal pain and ankle swelling were unknown. It was unknown if the reporter considered the injection site swelling, injection site pain, injection site erythema, injection site inflammation, abdominal pain and ankle swelling to be related to SHINGRIX. Additional details were provided as follows: The patient experienced injection site reaction over the weekend which included redness, swelling and pain at the injection site which appeared to have worsened as of 23rd July 2018 as inflamed area moved more around the arm. Three days after receiving SHINGRIX, the patient also experienced ankle swelling and pain in the abdomen. It was reported that, the patient did not have any evidence of issues with breathing or other signs of an allergic reaction.
PATIENT SIGNED UP ONLINE FOR PFIZER VACCINE 3RD DOSE.  SHE DID NOT PRESENT WITH HER VACCINE CARD. I ASKED WHEN HER 2ND DOSE WAS ADMINISTERED, SHE SAID 1/25/21.  I CONFIRMED THAT SHE WAS SUPPOSED TO GET PFIZER.  I ADMINISTERED PFIZER.  LATER WHEN I CHECKED , THE REGISTRY REPORTED SHE RECEIVED MODERNA.  I CALLED HER BACK TO THE PHARMACY TO EXPLAIN THE SITUATION.
shingles; Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication.   On 21-NOV-2011 the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (dose, route, lot# and expiration date were unknown) by a healthcare provider for the long-term prevention of shingles and/or zoster-related conditions (for prophylaxis). Subsequent to inoculation, the patient was treated for shingles.  As a direct and proximate result of patient's use of the zoster vaccine live(ZOSTAVAX) vaccine, patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.  Additional information has been requested.
A patient received an expired vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number- 00489116) and transmitted to Sanofi on 23-Feb-2021.  This case involves one-year-old male patient who received an expired 0.5 mL first dose HIB (PRP/T) VACCINE [ACT-HIB] (lot UJ112AA and expiry date: 21-Jun-2020) via an intramuscular route in the left thigh for prophylactic vaccination on Monday, 22 Feb (year not reported) given by one of the Medical Assistants (Expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX).  This was a case of actual medication error due to expired vaccine used (latency same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
PATIENT RECEIVED VACCINATIONS AND 1 MINUTE AFTER VACCINATIONS PATIENT FELT DIZZINESS. LAID PATIENT ON EXAM TABLE. PATIENT LAID FOR 5 MINUTES BEFORE SHE FELT BETTER. KEPT PATIENT LAYING DOWN FOR 15 MINUTES. BP 115/67. PATIENT STATED FELT GOOD ENOUGH TO SIT UP. GAVE PATIENT WATER. BP 103/63. PATIENT STOOD UP AND BEGAN TO FEEL DIZZY AGAIN. LAID PATIENT BACK DOWN. BP 120/75. GAVE PATIENT SUCKER SINCE HAD NOT EATEN LUNCH. PATIENT LAID FOR 10 MINUTES. PATIENT SAT UP AND FELT BETTER. BP 116/77. PATIENT STOOD UP AND STATED FELT MUCH BETTER. BP 122/77. WALKED PATIENT TO CAR AND INFORMED HER TO LAY DOWN IF FEEL DIZZY AGAIN. IF WORSENS GO TO ER.
Pt got two shots on 7/06/16 at around 10AM. Started having fever around 3pm and went to ER same date at 9pm due to high fever and headache. Called pt on 7/10/16 pt recovered and now having some minor HA.
This case was reported by a nurse via sales rep and described the occurrence of taste metallic in a adult female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of dysgeusia (1st dose received on an unknown date (see case:US2018GSK146267)). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, immediately after receiving SHINGRIX, the patient experienced taste metallic. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the taste metallic was recovered/resolved. The reporter considered the taste metallic to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient presented onset of metallic taste right after the SHINGRIX shot that lasted 5 days and went away after that. The reporter did not agree to follow up. This case was linked with US2018GSK146267, reported by the same reporter.
High fever (4/30-5/1). Measles like rash on legs and feet (5/2-5/6). Measles like rash on torso and back (5/8-today 5/9).
Patient's arm had a fever, very hot to touch and swollen. The heat radiated from the injection in a circular area and spanned approximately 4-5 inches across. Patient complained of itching and soreness in area. Patient started Benadryl 25 mg every 6 hours and cool compresses to the area. The patient plans to proceed to the doctor tomorrow AM since the area is still the same as of 9/18/12.
patient was administered Moderna vaccine (initial shot) and within 48-72 hours became short of breath.  He presented to my office for evaluation 4/14/2021 and found to have right leg DVT and massive bilateral pulmonary emboli with left lung infarction.
flu-like symptoms and swollen neck lymph nodes on the right side up to 2.5 weeks after second dose.
Information has been received from a physician concerning a female who was vaccinated intramuscularly on an unspecified date with her third dose of GARDASIL (lot# not reported).  Concomitant therapy included hepatitis A vaccine (unspecified) on the same day.  Subsequently the patient fainted at her home that day.  Her father is also a  physician sent her for bloodwork.  The results showed her liver enzymes were elevated.  Subsequently the patient recovered from fainting.  Additional information has been requested.  10/08/08 This is in follow-up to report(s) previously submitted on 5/14/2008. Information has been received from a physician concerning a 18 year old female who was vaccinated intramuscularly in the right deltoid on 27-DEC-2007 with her third dose of GARDASIL (lot# 659437/1266U). Concomitant therapy included VAQTA (lot# 657304/0246U) on the same day. Subsequently the patient was dizzy and fainted at her home that same day. Her father who is also a physician sent her for bloodwork. The results showed her liver enzymes were elevated. Subsequently, the patient recovered from fainting and being dizzy. Additional information has been requested.
One day post vax, pt experiences vertigo and nausea. They physician sought unspecified medical attention. Additional information has been requested.
Fever, chills, myalgia, new loss of taste and smell Sore throat and Cough Shortness of Breath Fatigue Headache Diarrhea
30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date; no adverse event; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    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 EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date).    This case contains information for the 1st of 30 adult patients described by the reporter. Concomitant Medication use information was not provided by reporter. There were 13, 11, and 6 different doses were given. The 30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date. The batch lot no 022D21A expired on 20 Apr 2022, the Lot number 033F21A expired on 08 Apr 2022 and the Lot number 037C21A expired on 02 Jan 2022. Treatment Medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-704487 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704487:Master case
immediately after the MA gave injection a rash occurred B/L arms, edematous orbital rash appeared, B/L face swelling,  followed by rash on back of neck
Used Pfizer for booster; First does of J&J vaccine; First does of J&J vaccine; Whole arm was weak and soar; Whole arm was weak and soar; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Janssen covid-19 vaccine (Dose 1, Single (First does of J&J vaccine)), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Used Pfizer for booster"; OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown" and all described as "First does of J&J vaccine"; PAIN IN EXTREMITY (non-serious), MUSCULAR WEAKNESS (non-serious), outcome "unknown" and all described as "Whole arm was weak and soar".  The lot number for bnt162b2 was not provided and will be requested during follow up.