chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine is placed in refrigerator on 17-Nov-2021, expired product date on 13-Oct-2021, administration date on 29-Nov-2021; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine is placed in refrigerator on 17-Nov-2021, expired product date on 13-Oct-2021, administration date on 29-Nov-2021) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine is placed in refrigerator on 17-Nov-2021, expired product date on 13-Oct-2021, administration date on 29-Nov-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine is placed in refrigerator on 17-Nov-2021, expired product date on 13-Oct-2021, administration date on 29-Nov-2021) outcome was unknown. Not provided.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. There was a confusion between the expiration date printed in the carton and the expiration date when the QR code was scanned. Date place in refrigerator was 17-Nov-2021. Patient did not experience temperature excursion and any adverse event. No treatment medication information was provided.   This case was linked to MOD-2022-491837 (Patient Link).
Arm Muscle Pain; This case was reported by a consumer via call center representative and described the occurrence of myalgia upper extremities in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (On 24th October 2019, received 1st dose. (For 1st dose refer case US2020088759).   On 11th March 2020, the patient received the 2nd dose of Shingrix. On 11th March 2020, less than a day after receiving Shingrix, the patient experienced myalgia upper extremities. On an unknown date, the outcome of the myalgia upper extremities was not recovered/not resolved.   It was unknown if the reporter considered the myalgia upper extremities to be related to Shingrix.  Additional details were received as follows: The patient reported arm muscle pain with the second dose of Shingrix, which was not resolved. The patient also reported having a knot in muscle  that she had to stretch out.  No consent to follow-up with doctor was provided.  Patient was unable to provide lot number and expiration date. The reporter did not consent to follow-up. This case was linked to case US2020088759 for same patient. This case was linked to case US2020088762 by same reporter.  Note: the event of knot in muscle was captured in case US2020088759 as it was not confirmed whether after which dose the patient experienced the event.
Child had Hib #1 11/30/95 #2 3/6/96 #3 4/23/96 #4 3/21/01 #5 1/27/97. Labs done 1/27/04 showed negative Haemophilus B-pt has localized swelling 2 1/2" x 1 1/2" tender with fever 24h after 101 injection with given 2/18/04. Diltaret .5ml. Fm hx: mother had difficulty with MMR-getting immunity. Hx: asthma, steroids medications inhalers.
Patient with history of COVID vaccines who admited to hospital with COVID detected PCR.  Provider d/c note:  "Reason for Admission: Weakness, altered mental status, hyperglycemia 86-year-old male patient with past medical history of hypertension, diabetes mellitus, CVA, polymyalgia rheumatica on steroid,  patient lives at Assisted Living Facility was brought here by EMS due to febrile, and hyperglycemia of 515, tested positive for COVID   Brief Summary of Hospital Stay: (Include Significant Findings and Invasive Procedures) treated for acute metabolic encephalopathy, improving   Case was discussed with son  1/2 blood cultures positive for MRSA, being treated with IV vancomycin for now, initially thought to be contaminant, follow-up blood cultures, from 12/20 shows positive for MRSA    12/ 22 Right shoulder x-ray, MRI of the spine, requested  periods of confusion, getting MRI of the brain Continued positive MRSA bacteremia   11/ 23 MRI of the brain showed small late acute/subacute left postcentral gyrus, requested neurology consultation, added aspirin to Eliquis   12/24 Improving, PICC line requested for 6 weeks course of IV vancomycin   12/25 Stable, appreciate neurology consultation for acute to subacute CVA  12/ 27 Stable  PICC line done 12/27    COVID illness , positive since 12/18 with mild sepsis ( fever and tachycardia ), sepsis has resolved        Acute metabolic encephalopathy likely from the combination of hyperglycemia and fever and COVID illness - admit  - no evidence of desaturation but will continue to monitor pulse oximetry closely - not a candidate for Decadron or remdesivir as he is not a very high risk patient - supportive management and treatment Improving   Failure to thrive, generalized weakness PT/OT evaluation SNF was recommended   Poorly controlled diabetes last hemoglobin A1 c of 8.4 on 11/29  Outpatient metformin on hold, started Lantus insulin, on correction insulin
101.5 fever; Chills; Body aches; Headache; This is a spontaneous report from a non-contactable consumer, the patient. A 44-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the arm left on 06Apr2021 at 09:30 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high and obesity and COVID-19 (Prior to the vaccination, the patient was diagnosed with COVID-19). The patient had no known allergies to medications, food or other products. The patient did not take any concomitant medications. 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 COVID vaccine. On 06Apr2021 at 23:00, the patient experienced 101.5 fever, chills, body aches, headache. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of fever, chills, body aches, headache were resolved on an unknown date in Apr2021.   No follow-up attempts are possible. No further information is expected.
No adverse effects reported; Multiple patients were vaccinated with improperly stored VAQTA; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On 12-JUN-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (units not provided), lot # R018935, expiration date 05-SEP-2019, for prophylaxis (dose, route, anatomical site and frequency were not reported). The reporter stated that the vaccine had a temperature excursion of 34.2 F for 4 hours and 54 minutes, which was detected by a data logger. The vaccine had no previous temperature excursion and there were no adverse effects reported.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-1907USA001174: US-009507513-1907USA004852: US-009507513-1907USA004853: US-009507513-1907USA004854: US-009507513-1907USA004855: US-009507513-1907USA004856: US-009507513-1907USA004857: US-009507513-1907USA004858: US-009507513-1907USA004859: US-009507513-1907USA004860: US-009507513-1907USA004861: US-009507513-1907USA004862: US-009507513-1907USA004863: US-009507513-1907USA004864: US-009507513-1907USA004865: US-009507513-1907USA004866: US-009507513-1907USA004867: US-009507513-1907USA004868: US-009507513-1907USA004869: US-009507513-1907USA004871: US-009507513-1907USA004872: US-009507513-1907USA004873: US-009507513-1907USA004874: US-009507513-1907USA004875: US-009507513-1907USA004876: US-009507513-1907USA004877: US-009507513-1907USA004878: US-009507513-1907USA004879: US-009507513-1907USA004880: US-009507513-1907USA004881: US-009507513-1907USA004882: US-009507513-1907USA004883: US-009507513-1907USA004884: US-009507513-1907USA004885: US-009507513-1907USA004886: US-009507513-1907USA004887: US-009507513-1907USA004888: US-009507513-1907USA004889: US-009507513-1907USA004890:
received dose from vial that had black particulates in previous syringe; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT QUALITY ISSUE (received dose from vial that had black particulates in previous syringe) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2021, the patient experienced PRODUCT QUALITY ISSUE (received dose from vial that had black particulates in previous syringe). On 01-Dec-2021, PRODUCT QUALITY ISSUE (received dose from vial that had black particulates in previous syringe) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was provided by the reporter.
had the single shingle shot in 2018; had shingles/ last time in august 2021; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (patient experienced 1st shingles outbreak on an unknown date, refer case US2021AMR227108).   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. In August 2021, more than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the shingles and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The reporter was patient. The age at vaccination was not reported. The patient had the single shingle shot in 2018 and experienced shingles 2 times. The last time in August 2021.  The patient asked if when patient can get the shingles shot?; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR227108:same reporter same patient
Adult patient received the dose after its expiration date 13-Jul-2022; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Adult patient received the dose after its expiration date 13-Jul-2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 004m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Adult patient received the dose after its expiration date 13-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Adult patient received the dose after its expiration date 13-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Adult patient received the dose after its expiration date 13-Jul-2022).    This case contains information for the 28th of 56 patients described by the reporter.  Concomitant medication was not provided.  It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.   Doses were administered after 30-day use by date or after manufacturer date of expiry. It was unknown to HCP when the vials were stored in the refrigerator and when the doses were administered. The vial did not undergo any temperature excursions.  Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-701125 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-701125:Master case
about 3 days p/vax pt devel red rash on chest, arms & has progressed to abd, groin, back & legs;rash on chest, upper arms very itchy, burning;felt like it was on fire or had been parboiled;rash on forearms;flu achy-out of sorts;
This spontaneous report as received from a consumer refers to a "baby" patient of unknown age. On an unknown date, the patient was vaccinated with M-M-R II (lot#, dose frequency, route and duration not reported). No other co-suspects were reported. No concomitant medications were reported. The consumer indicated that she knew someone's baby that was administered the M-M-R II and the baby stopped breathing. The consumer indicated the baby did recover. The relatedness of the event with M-M-R II was not provided. It was unknown if the patient sought medical attention. Upon internal review the baby stopped breathing was considered to be medically significant. Additional information is not expected.
03/24/2021 - Mild sore throat in the evening. 03/25/2021 - Moderate sore throat, moderate fatigue and muscular pain. 03/26/2021 - Mild sore throat and mild fatigue. 03/27/2021 - Moderate sore throat, moderate fatigue and muscular pain. Low grade fever of 99.1F. 03/28/2021 - Moderate sore throat, mild ear pain, eye pain/pressure. Fever spiked to 102.4F during the night. 03/29/2021 - Severe inflammation of the right side tonsils, severe ear pain, severe eye pain/pressure, fever of 101.9F. Consulted a doctor on MD Live who felt it might still be a reaction to the vaccine and prescribed Ibuprofen 600mg to manage symptoms. 03/30/2021 - Extremely severe inflammation of the right side tonsils, severe ear pain, severe eye pain/pressure, low grade fever of 99.5F.  03/31/2021 - Symptoms same as 03/30/2021. Consulted a doctor at the local Urgent care clinic. Prescribed amoxicillin-clavulanate and predniSONE.
On 05/09/2002, the pt developed fatigue for two days and on 05/11/2002, she developed red rash that started on face. On 05/12/2002, she presented a fever of 100 deg F and on 05/13/2002, she felt nausea (tiny red dots, some raised).
No adverse event to report. Pt. receive Monovalent Pfizer for 2nd dose 4/21/2023. MTF did not receive notification to use only Bivalent booster until 4/24/23 via program
Approximately 25 minutes after receiving MCV4 and HPV vaccinations, patient reported back to immunization clinic complaining of a raised swollen spot on her left hand that was numb. After administering oral BENADRYL and observing patient for another 45 minutes with provider supervision, patient felt fine.
high pitched scream followed by 15 mins of extremely pale skin, dec responsiveness, tone;
Fever over 24 hours that climbed to 105.8.  Fever started about 2 hours after injection but remained between 102-103 until 4:00PM Thursday, May 20, 2021 at which point it began to climb.  It finally peaked around midnight and then fell very fast over the course of about two hours to between 100 and 102 where it remained until Saturday evening, May 22, 2021 around 6:00 at which point it began to slowly drop back down to the 99-100 range where it stayed for an additional two days before dropping again to below 99.
This case was reported by a consumer via call center representative and described the occurrence of headache in a 59-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (in 2015). Previously administered products included SHINGRIX with an associated reaction of headache (1st dose received on an unknown date, refer case US2018GSK231619). On 10th December 2018, the patient received the 2nd dose of SHINGRIX. On 11th December 2018, 1 days after receiving SHINGRIX, the patient experienced headache, nausea, chills, fever, stomach pain, joint pain, muscle pain, injection site pain and injection site erythema. On 13th December 2018, the patient experienced blister, eye pruritus, burning in eyes, facial neuralgia, nasal burning, swollen mouth and toothache. The patient was treated with valaciclovir hydrochloride (Valacyclovir). Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the headache, blister, eye pruritus, burning in eyes, facial neuralgia, nasal burning and toothache were not recovered/not resolved and the outcome of the nausea, chills, joint pain, muscle pain, injection site pain and injection site erythema were unknown and the outcome of the fever and stomach pain were recovered/resolved and the outcome of the swollen mouth was not recovered/not resolved. It was unknown if the reporter considered the headache, nausea, chills, fever, stomach pain, joint pain, muscle pain, injection site pain, injection site erythema, blister, eye pruritus, burning in eyes, facial neuralgia, nasal burning, swollen mouth and toothache to be related to SHINGRIX. Additional details were provided as follows: The next day of having the SHINGRIX vaccine, the patient experienced headache, nausea, chills, fever, stomach pain, joint pain, muscle aches, injection site pain, red at the injection site and muscle pain at the injection site. So far, the stomach pain was gone and the patient thought that the fever was gone. The headache was worse.  But all other side effects were getting better. In addition, a day before the date of reporting the patient started experiencing blisters. She explained that she had blisters under her nose, nasal cavities on both sides, bottom of nose, all over her upper lips, all over lower lips and left corner of mouth down to each side. The patient's eyes were itching terribly and burning. Her left eye was especially itching a lot. She was also having nerve pain on her face on her forehead and on each cheek. Her nose felt like burning. She was having muscle pain all over her body. The inside of her mouth was swollen and her teeth ache when she ate. The patient had not visited her physician. She called her pharmacist and her pharmacist called her physician and she had a prescription for valacyclovir filled. The patient did not consent to be followed up.
placed in the fridge and given beyond the 30-day expiration to 7 patients; No adverse event; dose given beyond 30-day expiration date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose given beyond 30-day expiration date), PRODUCT STORAGE ERROR (placed in the fridge and given beyond the 30-day expiration to 7 patients) 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 vaccination.     No Medical History information was reported.    On 26-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose given beyond 30-day expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (placed in the fridge and given beyond the 30-day expiration to 7 patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose given beyond 30-day expiration date), PRODUCT STORAGE ERROR (placed in the fridge and given beyond the 30-day expiration to 7 patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (dose given beyond 30-day expiration date) and PRODUCT STORAGE ERROR (placed in the fridge and given beyond the 30-day expiration to 7 patients).    No concomitant medication was reported.  The caller called and said that the vials were initially stored in the refrigerator on 06-Jul-2022. It was unknown if individual vials or unbroken cartons were used. The vial size was unknown. The caller needed information on stability after 30 days and if there were recommendations on revaccination.  The vials did not undergo any temperature excursions.  No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 10-Nov-2022: Live Follow-up contains suspect product information updated. On 10-Nov-2022: Live Follow-up contains patient demographic added.
Diarrhea progressing to Black and bloody diarrhea starting within 6h post injection and resolving 48h-72h later.   Additionally fevers, chills and body aches were present 12h post injection and lasted for ~24h duration.
Pt reported to school health office 1:45 pm, 5/16/08, 3h after iz, with rash on (L) arm - HPV side. 3 areas on arm, 1 the size of a silver dollar, 2" below injection site. 2 smaller spots near elbow, each 1cm in size; Tx with itch relief; parent contacted. Observed for 40 min; sent home; f/u 5/19: no hives; patient reported they resolved after 4 hours.
fluid retention; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FLUID RETENTION (non-serious), outcome "unknown", described as "fluid retention".  Additional information:He had fluid retention and just came out from the hospital. According to him, he has a hard time driving because of his condition. He is asking if he can postpone his 2nd dose today and get his 2nd dose next week.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient experienced burning at injection site and a significant red area with a couple of blisters looked like a large bruise purple /red.
Patient received the expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received the expired vaccine) in an 89-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 11-Nov-2021 at 12:57 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 ml. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021 at 12:57 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received the expired vaccine). On 11-Nov-2021 at 12:57 PM, EXPIRED PRODUCT ADMINISTERED (Patient received the expired vaccine) had resolved. Not Provided          Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Developed Guillain Barre 4 weeks after flu vaccine 3/2014. Fall and extensive hospital and rehab.