chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the vial was initially stored in the refrigerator 07-Mar-2023, administration of vaccine 6-Apr-2023; No adverse event; We had a nurse gave an expired vaccine on 06Apr2023; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We had a nurse gave an expired vaccine on 06Apr2023), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator 07-Mar-2023, administration of vaccine 6-Apr-2023) and NO ADVERSE EVENT (No adverse event) in a 21-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 044C22) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 06-Apr-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 06-Apr-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (We had a nurse gave an expired vaccine on 06Apr2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator 07-Mar-2023, administration of vaccine 6-Apr-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We had a nurse gave an expired vaccine on 06Apr2023), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator 07-Mar-2023, administration of vaccine 6-Apr-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (We had a nurse gave an expired vaccine on 06Apr2023) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator 07-Mar-2023, administration of vaccine 6-Apr-2023).    No concomitant medication were reported.  Patient received Monovalent adult dose. Vial size was 5.5 mL. The vial was initially stored in the refrigerator on  07-Mar-2023. The vial did not undergo any temperature excursions. No treatment information was provided by the reporter.
Patient with known recent diagnosis of terminal hepatocellular carcinoma and necrotizing myositis on prednisone, within 2 hours after vaccine experienced vomiting and chest pain, on CT abdomen/pelvis in ED found to have bleeding from known hepatocellular carcinoma leading to hemoperitoneum treated with embolization of left hepatic artery and left gastric artery - given known underlying HCC, this is unlikely to be related to COVID vaccine.
Information has been received from a physician concerning a female child who on 9/3/2004 was vaccinated virus vaccine live (lot 646675/0710N). It was reported that the patient had breakthrough chickenpox of about 40 lesions. Subsequently, the patient recovered without any additional problems. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Injection site warm; Injection site Pink; Injection site raised; rash appeared around the injection site/rash is of the size of her palm (6x8 cm); This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (Injection site warm), VACCINATION SITE DISCOLOURATION (Injection site Pink), VACCINATION SITE MASS (Injection site raised) and VACCINATION SITE RASH (rash appeared around the injection site/rash is of the size of her palm (6x8 cm)) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Injection site warm), VACCINATION SITE DISCOLOURATION (Injection site Pink), VACCINATION SITE MASS (Injection site raised) and VACCINATION SITE RASH (rash appeared around the injection site/rash is of the size of her palm (6x8 cm)). The patient was treated with CORTISONE at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Injection site warm), VACCINATION SITE DISCOLOURATION (Injection site Pink), VACCINATION SITE MASS (Injection site raised) and VACCINATION SITE RASH (rash appeared around the injection site/rash is of the size of her palm (6x8 cm)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included blood pressure pills.  Treatments also included cool compress.
This spontaneous report was received from the registered nurse regarding 1 day old female patient who on 18-JUN-2014 at 15:49 P. M was vaccinated with improperly stored fist dose of RECOMBIVAX HB (thimerosal Free) (lot # J012520, expiration date 30-JAN-2016) intramuscularly. The reporter stated that, on unspecified dates (between May 14 and July 21) vaccine storage temperature dropped to 0-1 degree in 18 different episodes, and that according to minimum and maximum, all recorded temperatures were supposed to be between 2-8 degree. Additional information is not expected because all follow up information was received.
This spontaneous report was received from a physician via an unspecified reporter referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 07-JAN-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 "10PK 0.5mL SD-PFS LLokwTip 10Pk" and  lot # L014876 with expiration date 13-JAN-2017 (route of administration and anatomical location were not reported), which was stored at a lowest recorded temperature of 27F (-2.7 Celsius) for 1584 hours. The vaccine status was reported as excursion and the storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
after shot administered pt reported worst dizziness they have ever experienced, ringing in ears, and blurred vision, had pt lay in supine position with feet elevated, all sx resolved within 15-20 minutes, advised pt to follow up w/ PCP
10:22 Approximately 2 minutes after injection patient became diaphoretic, pale. patient was asked if she was ok, she responded by stating she felt faint. Patient laid her head down on desk, became more lethargic but was still able to answer questions appropriately but quietly and slow. Skin very pale, patient acted very sleepy. Patient was assisted with two RN's to floor to supine position, legs elevated. Ice packs placed to back of neck and vital signs taken with BP 90/70, pulse 97, respirations 12, unlabored and SP02 was 99%. patient remained slow to respond but did respond appropriately when aroused. Appeared very weak, grips equals, answered questioned appropriately but slow. Pupils reactive and equal. 10:45 Continued to monitor without much change, responded to voice commands, remained pale and sleepy. BP 104/70, HR 95, SP02 9%. 10:32 Continued to monitor, remained diaphoretic and pale. Tried to assist to sit and patient would not sit upon her own.  Respirations remained unlabored and skin pale. Would not open eyes without repeated demands. 10:35 Continue to monitor, no changes noted BP 108/74 HR 88 and SPO2 99%. 10:40 Notified 911 by Site Manager. No changes in patient condition.  Patients friend was notified by RN due to no family locally. 10:47 BP 102/76  HR 85 SPO2 99%.  Patient remained pale, arouses slowly, answers questions but slow and quietly. Ambulance personnel arrived.  report given to ambulance crew.  Patient was triaged by ambulance staff, placed on cot and taken to Hospital.  All patient belongings jacket, hone, keys and cup were given to ambulance crew.
This spontaneous report was received from a healthcare worker and refers to 9 unspecified patients of unknown age and gender. The patients' medical histories and concurrent conditions were not reported. On an unknown dates, the patients were vaccinated with the improperly stored doses of (Merck) VARIVAX (Lot# L008271; expiration date 11-MAR-2017; dose and route of administration were not reported). No adverse effects were reported. Follow up information was received on 23-OCT-2015 from a certified medical assistant. The medical assistant noted that the number of patients who were vaccinated with improperly stored doses of (Merck) VARIVAX (Lot# L008271) was 8, not 9 as previously reported. Follow-up information has been received on 27-OCT-2015 from the certified medical assistant. The reporter provided that the patient of unknown age and gender was vaccinated with the improperly stored dose of (Merck) VARIVAX on 10-AUG-2015. It was reported that the vaccine was 1012 hours out of range. This is one of several reports received from the same reporter. Additional information has been requested. Patient, product and event details and analysis were updated.
Left arm became were sore and difficult to lift soon after the vaccination on Thursday (10-21-21).  By that evening she could barely lift her left arm.  She also complained of muscle weakness and lethargy.  By the next evening (Friday) all her limbs were affected.  She felt tingling in all her limbs.   Saturday morning she could barely sign her name and she felt shaky and weakness with ambulation.  This continued through the weekend.  On Monday, she walked outside for a short distance and was short of breath which is unusual for her.  As she stood talking with her neighbor she fell.  She also complained of balance problems.  She was seen in the ER and admitted over night.  Tests and lab work were performed.  She was discharged to home the next day and told to see her medical provider and if her symptoms were not better to see a neurologist.  As of 10/27/2021, patient's symptoms are no better.  She has appt with her medical provider on Nov 12th.
8th day post vaccination, injection site is red,  indurated, warm To touch and itchy. Mild discomfort associated with symptoms (4/10 on pain scale)
This spontaneous report as received from a registered nurse refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On 25-JUL-2018, the patient was vaccinated with improperly stored doses of Oka-Merck PROQUAD either from lot # R002939, expiry date: 29-JUL-2019 or lot # R006218, expiry date: 28-AUG-2019 (dose, frequency and route were not reported) for prophylaxis. DILUENT MRK INJ was properly stored. No adverse effects were reported. No product quality complaint was involved. The Oka-Merck PROQUAD was stored in temperature of 15 degree Fahrenheit (F) to 46 F for 14 hours on 16-JUN-2018. No previous temperature excursion was reported. A digital data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA001261: US-009507513-1808USA004381:Original Case : 1808USA001261 US-009507513-1808USA004382:Original Case : 1808USA001261 US-009507513-1808USA004383:Original Case : 1808USA001261 US-009507513-1808USA004384:Original Case : 1808USA001261 US-009507513-1808USA004385:Original Case : 1808USA001261 US-009507513-1808USA004380:Original Case : 1808USA001261 US-009507513-1808USA004379:Original Case : 1808USA001261 US-009507513-1808USA004376:Original Case : 1808USA001261 US-009507513-1808USA004377:Original Case : 1808USA001261 US-009507513-1808USA004378:Original Case : 1808USA001261 US-009507513-1808USA004386:Original Case : 1808USA001261 US-009507513-1808USA004387:Original Case : 1808USA001261 US-009507513-1808USA004388:Original Case : 1808USA001261 US-009507513-1808USA004362:Original Case : 1808USA001261 US-009507513-1808USA004363:Original Case : 1808USA001261 US-009507513-1808USA004389:Original Case : 1808USA001261 US-009507513-1808USA004390:Original Case : 1808USA001261 US-009507513-1808USA004391:Original Case : 1808USA001261 US-009507513-1808USA004364:Original Case : 1808USA001261 US-009507513-1808USA004392:Original Case : 1808USA001261 US-009507513-1808USA004394:Original Case : 1808USA001261 US-009507513-1808USA004395:Original Case : 1808USA001261 US-009507513-1808USA004396:Original Case : 1808USA001261 US-009507513-1808USA004365:Original Case : 1808USA001261 US-009507513-1808USA004366:Original Case : 1808USA001261 US-009507513-1808USA004367:Original Case : 1808USA001261 US-009507513-1808USA004397:Original Case : 1808USA001261 US-009507513-1808USA004398:Original Case : 1808USA001261 US-009507513-1808USA004399:Original Case : 1808USA001261 US-009507513-1808USA004368:Original Case : 1808USA001261 US-009507513-1808USA004369:Original Case : 1808USA001261 US-009507513-1808USA004400:Original Case : 1808USA001261 US-009507513-1808USA004401:Original Case : 1808USA001261 US-009507513-1808USA004370:Original Case : 1808USA00126.
worst migraine headache of my life.  Have had occasional migraine auras but not headaches
hallucinations; bad dreams; This case was reported by a consumer via call center representative and described the occurrence of hallucination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th July 2021, the patient received the 1st dose of Shingrix. In July 2021, 12 hrs after receiving Shingrix, the patient experienced hallucination (serious criteria GSK medically significant) and bad dreams. On an unknown date, the outcome of the hallucination and bad dreams were unknown.   It was unknown if the reporter considered the hallucination and bad dreams to be related to Shingrix.  Additional details were provided are as follows: The case was reported by patient herself. The patient received a dose of Shingrix and she experienced after 12 hours hallucinations and very bad dreams. The reporter did not had lot number and expiration date. The reporter consented to follow-up by phone.
Information has been received for a pharmacist concerning a 70 year old female with a history of rheumatoid arthritis who on 07-DEC-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route and lot # not reported). The patient had a bunch of concomitant medications, too many to provide at that time. The patient had been complaining of intermittent pain at the site of the injection. The patient did not know exactly how soon after the injection the pain started. The patient had not seen her physician and sought unspecified medical attention. At the time of the report, the patient's status was not recovered. Additional information has been requested.
The pt experienced a fever on 3/20/01 and on 3/21/01 the pt was acting fine and then suddenly started shaking while sitting, than collapsed. Mom states the pt was unresponsive.
This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 03-JUL-2015, the patient was vaccinated with improperly stored dose of M-M-R II lot # K016154 with exp. 24-SEP-2016, (route and dose were not provided). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
PER PATIENT'S WIFE: PATIENT HAD A STROKE AND NEEDED TO HOSPITALIZED
Left axillary lymphadenopathy arising 3 days post-vaccination.  Ipsilateral lymphadenopathy worsening one week post vaccination with moderate pain (5/10 scale) to left axillary hyperplastic node.  Limited range of motion in left shoulder due to adenopathy.
he experienced tinnitus or ringing in his ears; This is a spontaneous report from a Pfizer sponsored program support. A contactable consumer reported for her son.  A 32-year-old male patient received BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration, on an unspecified date (at the age of 32-years-old) as dose 1, single for COVID-19 immunisation. The medical history and concomitant medications of the patient were not reported. It was reported that after taking the vaccine, the patient experienced tinnitus or ringing in his ears. After that, he refused to take the 2nd dose. 65 days have passed already. The reporter wanted to know if her son can still take the 2nd dose or does he have to repeat all over. The outcome of the event was reported as unknown.  Information regarding the lot/batch number has been requested.
Pt developed COVID-19 in January of 2022 and subsequently developed MISC for which she was hospitalized.
1 of 3 pt recv vax who exp a local rxn;event occurred 3-5 days following vax, described as local redness-4" in diameter @ inj site w/soreness;MD visit-ice recommended for tx-recovered;
Swelling, redness, warmth, hardness, inflammation, shingles-like pustular rash at injection site (left arm), low grade fever.
Pt experienced injection site reaction characterized by redness, swelling to the size of  silver dollar, warm to touch, and ecchymotic at site.
Erythema Nodosum. Fever, rash over shins, pain and swelling of leg, start 11/25/09; seen in ER 11/28/09-FLUZONE given 11/11/09; H1N1 vaccine given 11/17/09. Had cold sx, sore throat, rash from 11/12/09.
Patient lives in a SNF and received the first dose of the COVID-19 vaccine 1 day prior to admission. After the vaccine, patient had multiple rounds of vomiting. The next morning, patient was sent to emergency department for continued vomiting. On assessment, patient was found to have right sided opacities on chest x-ray. Patient was afebrile, with a normal WBC, and had mild increase in his chronic oxygen requirement. It was thought that these right sided opacities could be aspiration pneumonitis/pneumonia from the recurrent vomiting in a bed bound SNF patient. Vomiting leading to aspiration pneumonitis/pneumonia. Idiosyncratic response not expected from normal pharmacological mode of action (MOA) vomiting post vaccine leading to aspiration. Vomiting does appear to be linked to receipt of vaccine given timing. Of note, patient had COVID-19 requiring hospital admission approximately 1 month before receiving the COVID-19 vaccine. It is possible that the recent COVID-19 infection contributed to a worsened response to the COVID-19 vaccine.
DEVELOPED MENIERES 4 MONTH AFTER COVID VACCINE INJECTIONS ..NEVER HAD ANY INNER EAR PROBLEMS  BEFORE HAS THERE BEEN ANY RECORDED CASES OF THIS  MENTIONED TO PFIZER OR CDC.......THANK YOU
Swelling, and extreme redness spreading out from injection site on Left anterio lateral thigh.  Warm to the touch.  Redness approx 6-8 inches across.
The patient developed a rash on the same day as the vaccine. Patient was treated with Benadryl for 2 days.
Initial and follow-up information has been received from a nurse concerning several female patients who were vaccinated with doses of Gardasil. Subsequently the patients complained of burning as the Gardasil was being injected into their arms. The nurse reported that the burning has just recently been reported to her. On 27-AUG-2007 the nurse reported that she does not have the exact number of patients involved and that most patients complain about the injection. Unspecified medical attention was sought. At the time of the report the patients outcomes were unknown. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age. Concurrent conditions and medical history of the patient were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored doses of ROTATEQ (lot # K009900, expiry date 04-MAY-2016; lot @ K011948, expiry date 07-JUN-2016, lot# was reported as K016775 (invalid). expiry date 20-APR-2016; lot# K024700, expiry date 30-JUL-2016, lot #L001316, expiry date 10-NOV-2016; lot # L00453, expiry date 27-MAY-2016, lot # L013192, expiry date 19-JAN-2017) (dose, route unspecified). Concomitant therapies were not reported. No adverse effects were reported. This is one of several reports received from the same source, Additional information has been requested.
FEVER FOR ABOUT 12 HOURS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced fever for about 12 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever for about 12 hours. This report was non-serious.
Lot of pain at the injection site on the left arm; has pain on the right side, a lot of like right sided pain; Pain in her arm is now moved to her right shoulder blade area; had a vaccine and this would be her third booster with Pfizer; This is a spontaneous report from a contactable consumer. This consumer reported for a female Patient (sister).   A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number was not reported), dose 3 via an unspecified route of administration, administered in Arm Left on an unspecified date as DOSE 3 (BOOSTER), single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, the patient previously had COVID-19 vaccine (manufacturer unknown) first two completed in the series and then decided to do the booster because she works with small children. On an unspecified date, the patient had a lot of pain at the injection site on the left arm which was where the injection was given and about 2 to 3 days after that she has continued to not so well and has pain on the right side, a lot of like right sided pain. So, the pain that was in her arm was exact same pain that she said was now moved to her right shoulder blade area, she went and saw an urgent care doctor who has prescribed a muscle relaxer (treatment). The patient stated that, she was wondering that this was a reactions that you have heard about where like you kind of like have a systemic inflammatory response, do you know about any of this?"  The lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.
Chills/ severe body aches, headache began @ 8pm on 1/20/21 persisting through the night . Muscle aches & headache continues 1/21/21.
Flu vaccine on 9/25/08.  Pain at injection site after 24 hours.  "Symptoms of Tendonitis".  Still painful approximately 1 month later.  Limits ROM above shoulder one month later.  Will see doctor if persists.
Patient received flu shot 10/25/11 complains of arm pain from shoulder to elbow, wakes up pt at night - treating for OTC pain meds & heat.
Information has been received from an office manager concerning a female (age not reported), who was vaccinated with the 2nd dose of GARDASIL (Lot# not reported, dose, dates, and routes not reported). Concomitant medication and pertinent medical history were unspecified. On an unspecified date the patient developed "inflammation during a pap smear" right around the time she got her second dose of GARDASIL. Unspecified medical attention was sought. The outcome of the event was unspecified. No product quality complaint was involved. Additional information has been requested
Pt was given Hep A in the pm of 09-27-06 and later that eve developed urticaria.  Parents administered oral benadryl and symptoms abated.  Pt to school the next day, 09-28-06, without problems.  Pt returns from school with urticaria.  Pt brought to clinic and Benadryl IM given.  Symptoms abated and Pt released.