chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse refers to roughly 20 unspecified patients of unknown age. On an unknown date, roughly 20 unspecified were vaccinated with VARIVAX (Merck) Injection, (strength, dose, frequency, route of administration and indication were not provided) that reached 18.5 F for 10 hours and 44 minutes. This range was outside of storage conditions in product insert; however, in house stability data can support those conditions mentioned above that the VARIVAX (Merck) was exposed to. No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was reported. The outcome of events was unknown. No further adverse event information was available. Follow up information (after previous telephone attempts to obtain follow up information which has been unsuccessful) has been received from a nurse concerning VARIVAX (Merck) temperature excursion and one patient of unspecified age and gender who was vaccinated with VARIVAX (Merck) (injection, strength, dose, frequency, route of administration and indication were not provided) (lot # J012384, exp date: 31-OCT-2015 also reported as 03-OCT-2015) that reached 18.5 F for 10 hours and 44 minutes. This is one of several reports received from the same source. Additional information has been requested.
Injection site reaction on right upper arm -- patient reports a swollen, hard, red area around the entire arm, approximately 6-8" in diameter
Adacel administered post excursion with no reported adverse event; temperature excursion involving Adacel range from 31.7F to 52.4F for 300 hours due to a refrigerator malfunction with no reported adverse event; Initial information received on 22-Jul-2022 regarding an unsolicited valid non-serious case received from other health professional.   This case involves a 11 years old female patient to whom adacel administered post excursion with no reported adverse event and temperature excursion involving adacel range from 31.7f to 52.4f for 300 hours due to a refrigerator malfunction with no reported adverse event while receiving vaccine diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel].    The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   The condition from 05-Apr-2022 to 15-Jul-2022 was a range from 31.7F to 52.4F for 300 hours due to a refrigerator malfunction (not human error).    On 19-Jul-2022, the patient received suspect diphtheria-2/tetanus/5 AC pertussis vaccine at a dose of 0.5 ml (lot U6923AA, expiry date: 31-Jan-2023) via intramuscular route in the left deltoid for immunisation.  On an unknown date in 2022 there was temperature excursion involving adacel range from 31.7f to 52.4f for 300 hours due to a refrigerator malfunction with no reported adverse event (product storage error) (unknown latency) following the administration of diphtheria-2/tetanus/5 AC pertussis vaccine.  On 19-Jul-2022 adacel administered post excursion with no reported adverse event (poor quality product administered, latency: same day) following the administration of diphtheria-2/tetanus/5 AC pertussis vaccine.   Action taken: Not applicable.   Outcome: Unknown for the event temperature excursion involving adacel range from 31.7f to 52.4f for 300 hours due to a refrigerator malfunction with no reported adverse event and was Unknown for the event adacel administered post excursion with no reported adverse event.    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.
Reporting a vaccine administration error.  Patient was given a dose of Moderna vaccine that was expired at the time of administration.  Vial that dose was drawn from was moved from freezer to fridge on 8/30/2021 at 8:45pm, starting a 30 day expiration per manufacturer.   Error was discovered on 10/5/2021 after a subsequent vial from the same box was identified as being expired.  Manufacturer was contacted on 10/6/2021  for guidance.  Manufacturer indicated on 10/6/2021 that they will "conduct an analysis to determine if the vaccine administered past 30 days provided the necessary protection against a COVID-19 infection".  Patient was contacted and informed of the vaccine administration error.  Patient reports no AE's and is awaiting follow up guidance from manufacturer.
Vasposasm, flushing/sweating, dizziness, saw bright lights, pale, and HA. BP was 142/11 HR57, RR16. Patient recovered and was discharged in stable condition
Pt recv vax on 8/4/98; 15 mins later pt became pale, weak &fainted, vomited.
A red line in the form of a circle has appeared around the injection site - circle has appeared larger over time.  The injection site is warm to the touch and at one point was raised slightly.
+ non blanching erythematous patch with spotting darker erythema in center about 3cm x 5 cm diameter in left arm. Warm to touch. Treated with KEFLEX 250/s 1 1/2 tsp PO BID X 10  days.
Patient received potentially affected vials that was stored in freezer with no DDL monitoring; Patient received potentially affected vials that was stored in freezer with no DDL monitoring; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient received potentially affected vials that was stored in freezer with no DDL monitoring) and PRODUCT STORAGE ERROR (Patient received potentially affected vials that was stored in freezer with no DDL monitoring) in a 65-year-old male patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received potentially affected vials that was stored in freezer with no DDL monitoring) and PRODUCT STORAGE ERROR (Patient received potentially affected vials that was stored in freezer with no DDL monitoring). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient received potentially affected vials that was stored in freezer with no DDL monitoring) and PRODUCT STORAGE ERROR (Patient received potentially affected vials that was stored in freezer with no DDL monitoring) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter.  There was no change in the state of the vaccines, no temperature excursion history (the temperatures of the freezer remained consistently within range and was recorded in a log) and received them from shipment in frozen and remained frozen when in the freezer. Vial was thawed when patient came for vaccination. Storage condition was frozen. The lot numbers supposedly affected were 022J21A, 083J21A and 059M21A. Maximum/minimum temperatures were not recorded; only morning and evening temperatures were recorded. The excursion in question was from 8-Feb-2022 to 20-May-2022 and affected only 6 patients within that time frame. The vials were moved to the refrigerator to be thawed for vaccinations on 8-Feb-2022, 21-Feb-2022, 31-Mar-2022, 2-May-2022 and 20-May-2022. The vials were stored in a fridge/freezer combo unit which are completely separate compartments with completely different temperature.  No treatment medication was reported by reporter.
Post nasal drip, sore throat, cough, sinus pressure, nasal irritation, fatigue, night sweats, burning in chest   stay well-hydrated and well-nourished while resting appropriately For cough:  honey 1 to 2 teaspoons every 4 hours can help to quiet a cough  buPROPion SR (WELLBUTRIN SR)
didn't have any side effects with either one other than a sore arm.; hurt a lot; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included shingles shot with an associated reaction of pain in extremity (1st dose received on an unknown date refer case US2022AMR071643).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm and pain. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the pain in arm and pain were unknown.   It was unknown if the reporter considered the pain in arm and pain to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR071643   Additional Information: GSK Receipt Date: 27-APR-2022  Reporter's comment: This case was reported by a patient via Interactive Digital Media. The patient did not have any side effects with either one other than a sore arm.  The shingles shot hurt a lot more than the Covid shot. Additional supportive information:  Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR071643:same reporter
Vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient did not experience any adverse event.  No concomitant medications were reported.  No treatment information was reported.   This case was linked to (Patient Link).
> client complained of headache & nausea no other untoward signs/symptoms noted > assisted to cot. provided privacy. v/s taken, MD informed > v/s stable > offered, water, crackers, & hard candy > client felt better after rest > seen by MD via Facetime & Discharged to home
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Shakiness-Mild, Additional Details: PATIENT REPORT ITCHING IN HER THROAT AREA WITH A LITTLE TIGHTNESS AFTER COVID VACCINE, SO GAVE HER BENADRYL. A FEW MINUTES AFTER THAT, SHE WAS A LITTLE SHAKY AND DIZZY. EMS WAS CALLED, AND TENDED TO HER IN THE PHARMACY AREA. SHE WAS OK AFTER
Itchy at the injection site; Red rash at injection site; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION SITE PRURITUS (Itchy at the injection site) and VACCINATION SITE RASH (Red rash at injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history).    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 17-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy at the injection site) and VACCINATION SITE RASH (Red rash at injection site). On 12-Feb-2021, PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Itchy at the injection site) and VACCINATION SITE RASH (Red rash at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  The patient suspected she had an allergic reaction. No treatment was reported for the events.
April 13: Diarrhea,  nausea in morning. Fever of 100 at 4 pm, muscle aches. Fever morning of April 14 with Diarrhea,  fever gone by 3 pm.
At midnight I started coming down with a fever which peaked at 101.3.  Severe chills.  Body aches.  Headache.  Nausea.  Temp is still at 100.0 as of 8:51a on 2-13-2021.  Yes, I'm drinking water and taking Tylenol.
This case was reported by a consumer via call center representative and described the occurrence of generalized joint pain in a 56-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 9th February 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than 9 months after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced generalized joint pain, headache, tiredness, knee arthritis, fever, chills and incomplete course of vaccination. The patient was treated with meloxicam. On an unknown date, the outcome of the generalized joint pain, headache, tiredness, knee arthritis, fever and chills were recovered/resolved and the outcome of the incomplete course of vaccination was unknown. It was unknown if the reporter considered the generalized joint pain, headache, tiredness, knee arthritis, fever and chills to be related to SHINGRIX. Additional details were provided as follows: The patient called to inquire that it had been more than six months, and did she need to restart the series. The patient received 1st dose of SHINGRIX on right arm. The patient experienced fever, joint pain all over the body, chills, headaches, and tiredness, which lasted for total of 2 days. The patient also experienced inflammation and pain of the knee. The patient required a doctor's visit for the inflammation and pain in the knee. The patient was prescribed 7.5mg of Meloxicam. The patient recovered within 4 days from knee pain and inflammation. The patient continued to take Meloxicam for total of 2 weeks. Till the time of reporting, the patient did not receive the 2nd dose of SHINGRIX, which led to incomplete course of vaccination. The patient gave permission to contact her health care provider. The patient reported this event to her pharmacist, and her pharmacist has reported this event to VAERS. This was an accidental medication error associated with an adverse event.
Patient woke up the night that he received the vaccines and "didn't recognize" his mother.  He seemed confused (e.g., he didn't know where the light switch was which he normally knows).  Similar behavior occurred only at night for 5 consecutive nights.
Pt. came back to the clinic with complaining of hives and itching on bilateral lower legs.
Within 48 hours post vax, pt developed an injection site reaction characterized by swelling which extended to her elbow, pain and warmth.
Immediately after giving injection arm began to swell, some redness down to rash, given 50 mg BENADRYL PO.
This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Terrible fatigue) and TACHYCARDIA (rapid heart beat up to 128BPM) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (no medical history provided). On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Jan-2021, the patient experienced FATIGUE (Terrible fatigue). On 03-Mar-2021, the patient experienced TACHYCARDIA (rapid heart beat up to 128BPM). At the time of the report, FATIGUE (Terrible fatigue) and TACHYCARDIA (rapid heart beat up to 128BPM) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. No concomitant medications were provided. No treatment details were provided. Reporter did not allow further contact.
Felt ill; This case was reported by a pharmacist via sales rep and described the occurrence of feeling unwell in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was recovered/resolved.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The batch number was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and felt ill. The reporter would amend report with additional details once received.  The report incomplete as the reporter did not have adequate time to discuss. For tolerances of 2nd dose, refer case US2019AMR174202, reported by same reporter.
This spontaneous report was received from a medical assistant refers to a patient of unknown gender and age. Information regarding the patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapy were unspecified. On an unknown date, the patient was vaccinated with improperly stored VARIVAX (dose: 0.5 ml, lot # L048468, expiry date: 15-SEP-2017) via intramuscular route. Medical assistant reported that the vaccine was stored at 14.4 degree Fahrenheit for 3 hours 18 minutes. No adverse effects were reported. Additional information has been requested.
Chills, 103+ fever, weakness, tired;  Lasted approximately 48 hours
Before the shot I was fine. Once taken, a month later i began feelkng worse and needed to go the the hospital. Some of the symptoms are, Pins and needles feeling in face hands and feet, bloated stomach.
Vaccine administered 10/22/09. Patient seen 10/24/09 with erythema/ edema/ warmth, pain @ vaccine site. Treated w/ AUGEMNTIN for cellulitis. Erythema at site 2 inches diameter.
This 92 year old white male received the Covid shot on  2/23/21    and went to the ED and admitted on  5/3/21     and again to ED and admitted  on 5/5/21 with the following diagnoses listed below. I21.4 - NSTEMI (non-ST elevated myocardial infarction) (CMS/HCC) CHEST PAIN
This spontaneous report as received from a certified medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). The certified medical assistant reported that the vaccine was exposed to temperature of 26 F (Fahrenheit) for a total of 135 hours. No adverse effects reported. Follow-up received. Certified Medical assistant stated that other 104 children received GARDSIL. Follow up information has been received from the certified medical assistant regarding an unknown age (previously reported as child), male patient with no pertinent medical history reported. On 23-JAN-2013 the patient was vaccinated with GARDASIL (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.
PFIZER (COMIRNATY) COVID VACCINE #3 GIVEN 6/23/22, LOT # FM7553); 6/23/22 pt placed in a SNF after recent hospitalization due to falling at home and aspiration pneumonia; 6/27/22 pt  had a positive COVID test while in the facility; pt passed away in the facility
Suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient reported case for himself or herself. The age group was not reported but was captured as an adult as per the vaccine indication. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided. This case had been linked with case US2021AMR084136, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR084136:same reporter
Pt developed a temperature of 105F with Morbilliform rash, 8 to 9 days, post vax. He has Autism.
Dizziness; Headache; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (Dizziness) and HEADACHE (Headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     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 DIZZINESS (Dizziness) and HEADACHE (Headache). At the time of the report, DIZZINESS (Dizziness) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Red Arm Rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red Arm Rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Bee sting hypersensitivity.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH ERYTHEMATOUS (Red Arm Rash). At the time of the report, RASH ERYTHEMATOUS (Red Arm Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Pt came into office with hives, red and raised on left upper thigh around site of injection.