chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vails that were expired on 01-Apr-2022, was stored in refrigerator on 04-Apr-2022 and administered on 08-Apr-2022; Patient administered vaccine on 08-Apr-2022, which was Expired vaccine on 01-Apr-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine on 08-Apr-2022, which was Expired vaccine on 01-Apr-2022) and PRODUCT STORAGE ERROR (Vails that were expired on 01-Apr-2022, was stored in refrigerator on 04-Apr-2022 and administered on 08-Apr-2022) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine on 08-Apr-2022, which was Expired vaccine on 01-Apr-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vails that were expired on 01-Apr-2022, was stored in refrigerator on 04-Apr-2022 and administered on 08-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine on 08-Apr-2022, which was Expired vaccine on 01-Apr-2022) and PRODUCT STORAGE ERROR (Vails that were expired on 01-Apr-2022, was stored in refrigerator on 04-Apr-2022 and administered on 08-Apr-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vial was initially stored in the refrigerator on 04-Apr-2022. The vial did not undergo any temperature excursions. It was reported that pharmacist thought that the vaccine was expired in Jun-2022, however it was expired on 01-Apr-2022.  No treatment information was reported.
Injection site was sore for 2 days; however, 5 to 6 days later, I developed a rash on the upper left arm. I took Benadryl but that did not alleviate the rash or itching. The rash turned hard on the upper left of my arm and then smaller rashes ran down the arm. Today, March 10, I notice a rash beginning on the upper part of my right arm near the injection site. I have applied topical Benadryl cream to the rash which helps with the itching but the rash does not go away; instead it feels like small bumps underneath the skin.
No adverse symptoms reported; Improperly stored dose of varicella vaccine administered; This spontaneous report as received from a pharmacy technician refers to a 1-year-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medications were not reported. On 14-MAR-2018 the patient was vaccinated with improperly stored dose VARIVAX (lot # N022979, expiry date: 23-AUG-2019) (dose, frequency and route were not reported) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1802USA001558.
Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Lymph Node Swelling-Medium, Additional Details: Patient has lymph node swelling and was concerned
Information has been received from a physician concerning an 8 year old female who in July 1996, was vaccinated with a dose of varicella virus vaccine live (Oka/Merck).  On 04/30/2004 the patient was diagnosed with an atypical mild case of chickenpox.  It was reported that the patient had one lesion in the mouth, 2 lesions on the scalp and 12 lesions on the trunk.  She had less than 50 lesions and was afebrile.  Unspecified medical attention was sought, but no treatment was required.  No product quality complaint was involved.  No additional information was available.  Additional information has been requested.
Pain, / in the arm (site of injection); swollen / in the arm (site of injection); redness in the arm (site of injection); general discomfort.; This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced injection site pain, injection site swelling, injection site erythema and general discomfort. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site erythema and general discomfort were unknown.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema and general discomfort to be related to Bexsero.  Additional details were reported as follows: The age at vaccination was not reported. Nurse informed that after the vaccination of patient with Bexsero, the patient experienced pain, swollen, redness in the arm (site of injection) and general discomfort. The reporter consented to follow up. This case is 1 of the 13 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR209822:same reporter US-GLAXOSMITHKLINE-US2020AMR210159:same reporter US-GLAXOSMITHKLINE-US2020AMR210158:same reporter US-GLAXOSMITHKLINE-US2020AMR210160:same reporter US-GLAXOSMITHKLINE-US2020208660:same reporter US-GLAXOSMITHKLINE-US2020AMR210161:same reporter US-GLAXOSMITHKLINE-US2020AMR210157:same reporter US-GLAXOSMITHKLINE-US2020AMR210163:same reporter US-GLAXOSMITHKLINE-US2020AMR210164:same reporter US-GLAXOSMITHKLINE-US2020AMR210165:same reporter US-GLAXOSMITHKLINE-US2020AMR210166:same reporter US-GLAXOSMITHKLINE-US2020AMR210156:same reporter
This spontaneous report was received from a medical assistant and refers to an unknown number of patients of unknown age and gender. The patient's relevant medical history, concurrent conditions and concomitant medications were unknown. On an unknown date, the patients were vaccinated with improperly stored doses of either ZOSTAVAX (lot# and expiration date unknown) or VARIVAX lot# N030407 and expiration date 30-OCT-2019. Both vaccines were used for prophylaxis. Dose, strength, frequency, and route of administration were unknown. No adverse effects were reported. It was reported that the vaccines had a temperature excursion of 6 degrees Fahrenheit (F) to 14F for 30 minutes and 15F to 46F for 15 minutes. No previous temperature excursions were reported. Data logger was involved. As of 02-NOV-2018, all telephone attempts to obtain follow up information have been unsuccessful.
On 12/15 noticed red, big pimple which became back following day. Also about 6cmx4cm redness around, tender, swollen. Seen 12/17 with necrotic, black center about 1cm diameter. All in exact site of varicella injection. Treated with Augmentin and Acyclovir PO.
myocarditis; some pains; This is a spontaneous report received from non-contactable healthcare professional.  A male patient received bnt162b2 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDITIS (hospitalization, medically significant), outcome "unknown", described as "myocarditis"; PAIN (hospitalization), outcome "recovered", described as "some pains". The patient was having some pains. He ended up in the hospital. Reported causality was related.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt became nauseated about 5 minutes after receiving her first dose of the Pfizer vaccine. She dry-heaved about 3 times but did not vomit. She stated that she also felt hot so was given two ice packs. She had only eaten a handful of snacks that morning. Denied dizziness or lightheadedness. BP 110/72, pulse 64 bpm. After 5 minutes she stated that she was feeling better. Pt left after 15-minute observation period with symptoms resolved
Patient returned to pharmacy 24 hours after injection.  She woke up the morning after and noticed she had a rash on her arms, legs and chest.  I intstructed her to take Benadryl and contact her primary care doctor.  She was not having any trouble breathing, just was itching due to rash.
This spontaneous report as received from a licensed vocational nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored (15 hours in 34F) doses of PNEUMOVAX 23 (lot # reported as M013504 with expiration date 06-MAY-2018, lot # L018503 with expiration date 16-MAR-2017; dose and route of administration were not reported). No previous excursion and no adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Pt developed itchy patches of vesicles with erythematous base on left middle finger and right elbow 1 day after receiving vaccine. Also developed fever and irritability following vaccine that lasted 2 days.
Having some on and off pain like body aches; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer (patient). A female patient of an unspecified age received her first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE; unknown lot number and expiration date), via an unspecified route of administration, on an unspecified date, at a single dose for COVID-19 immunization. Medical history included COVID-19 from Apr2020 to an unknown date as she had COVID in Apr2020 and she has had after effect symptoms long term, diabetes, blood pressures (blood pressure abnormal) and cholesterol (blood cholesterol abnormal). Concomitant medication included lisinopril for blood pressures, metformin for diabetes and simvastatin for cholesterol. The patient reported that she received the first dose of the COVID vaccine on Sunday (unspecified date). She mentioned that she has been having some on and off pain like body aches on an unspecified date. She added that she had COVID in Apr2020 and she has had after effect symptoms long term. She stated that she thought these symptoms would disappear after first dose of COVID vaccine, but this did not happen, and she is hoping it will happen after the second dose. She inquired if she can take ibuprofen (MOTRIN) for body aches. The outcome of the event was unknown.  The following information on the batch/lot number has been requested.
Patient called and stated feeling some tingling on spots around my face. Nothing serious. Just like random small areas. Pt can still smile, talk and stick my tongue out normally. Pt states he had a red itchy spot over his eyebrow dime size but gone now, skin under his lower lip felt itchy and numb. He denies any chest pain pressure, SOB, wheezing, throat/tongue itching/swelling, diff swallowing, edema, GI sx. No hx of GB or Bells.  He is able to move and talk, blink, stick tongue out w/o issues.
Exactly 7 days after receiving Zostavax vaccination, client had painful blisters on her scalp and top of the head with severe headaches.  Saw her HCP and was placed on Valtrex and diagnosed as having Shingles.
Fever of 101 degrees, chills, joint pain, body aches, lymph node swelling and tenderness, headache.  Symptoms started 10 hours after injection and lasted for 14 hours
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 3:58 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 46.18.  Concomitant products were not provided.    On 03-Apr-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 210, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 03-Apr-2021. 20 vials were sent to clinic. Vaccine BUD date was 29-Apr-2021.  On 03-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 38, 9 AM: 34, 10 AM: 38, 11 AM: 42, 12 AM: 41, 1PM: 41, 2 PM: 41, 3 PM: 40, 4 PM: 40 and 5 PM: 41.    The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.    Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Extreme pain in right shoulder rendering the arm unmovable without severe pain. The pain was equivalent to a fracture or break. It was not a minor or even moderate pain, it was an intense pain that was nearly intolerable. I was considering going into the ER room to have it evaluated. I was concerned if serious damage had occurred due to the excessive pain. I've had kidney stones and this reaction was almost as painful as kidney stone pain or broken bone.
pt brought to ED via EMS; pt was semi-responsive, hypoglycemic, O2 sats 67% on RA; administered D50, O2 supplementation; positive COVID test in ED; pt found pulseless and apneic; CPR initiated; intubated; unable to achieve ROSC; pt died in the ED
88y.o. female with pmh of basilar artery stenosis, CAD, HTN, hypothyroidism, HLD, ILD on 3L home O2, BL knee OA, and seizure d/o admitted to the hospital on 8/23/2022 for LLE pain and weakness.  Patient recently admitted 8/18-8/22 after fall with LLE pain and facial cellulitis and was dx with COVID 19, imaging LLE negative at that time.  Imaging 8/23 in the ED showed L fibular fx. Ortho evaluated and recommend CAM boot with NWB LLE. Admission complicated by hyponatremia. She is stable for discharge to SAR. Discussed management plan with patient at bedside and daughter over phone. She will follow with her primary doctor and surgeon after discharge.
This spontaneous report as received from a vaccine coordinator refers to unspecified patients of unknown age and gender. The concurrent conditions, drug reactions/allergies and medical history of the patients were not reported. On unknown dates, the patients were vaccinated with a dose of improperly stored GARDASIL 9 with either lot number L037554 and expiration date of 25-DEC-2017 or lot number M018810 with expiration date of 28-MAY-2017 (strength, route of administration and dose were not reported), which was stored at 47.5 Fahrenheit degrees for 1 hour and 32.9 Fahrenheit degrees for 1 hour. There was no previous temperature excursion. The temperature excursions were detected by a data logger. There were no concomitant therapies reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 36-year-old female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), at the age of 36, on Mar 23, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The following information was reported: pain in extremity/arm was sore, with outcome of unknown. Additional information: Patient stated her arm was sore after. Event took place after use of product. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Patient reported visual disturbances (blurry vision) that were not resolving.  Patient reported noticing this approximately 10 minutes after receiving Shingrix.  Patient was advised by pharmacist to monitor for worsening symptoms or new symptoms.  Anaphylaxis was ruled out upon questioning.  Patient was advised to contact her primary care physician.
GOT COVID; This spontaneous report received from a consumer concerned five patients of unspecified age. No past medical history or concurrent conditions were reported. The patients were previously treated with both the doses of covid-19 vaccine (unspecified manufacturer) (Dose number in series 1) ( Form of admin, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. It was unknown whether patients experienced any adverse event (Dose number in series 1). The patients received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (suspension for injection, route of admin, batch number and expiration date were not reported) dose,1 total start therapy date were not reported for prophylactic vaccination (Dose number in series 2). The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, five family members who had both shots of the vaccine and the booster got covid (Dose number in series 2). Reporter did not know whether they had received the Janssen Covid-19 vaccine  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of event covid was not reported. This report was non-serious.
Rash all over body - approximate onset 3 hours after injection. Resolved by 11-23-09.
Pharmacist administered Pfizer COVID vaccine on 9/8/21. Following administration of the vaccine, the pharmacist identified that the vaccine was withdrawn from a vial past its beyond-use date after reconstitution. The pharmacist and pharmacy leadership immediately contacted the manufacturer (Pfizer) in accordance with published CDC deviation recommendations. Pfizer could provide no immediate recommendation and Pfizer collected specific vial/Lot information to provide further direction. Follow-up communication from Pfizer indicated that the manufacturer could not provide guidance on whether the vaccination needed to be repeated and directed the pharmacist to contact the CDC. On 9/9/21, the pharmacist notified the patient of the event and the potential need for re-dosing pending CDC response. Pharmacy leadership received follow-up from the CDC on 9/10/21 which included guidance for the patient to be re-vaccinated. This guidance was shared with the patient on 9/10/21.
Noticed a rash on the vaccinated arm. Started to spread a day after the vaccination and felt warm and sore to touch.
Prolonged diarrhea starting 2 days after vaccination, 10-12 times daily. Watery and mucousy lasting about 6 weeks. Not reported to MD until 8/24/15 after resolution.
This spontaneous report as received from a registered nurse refers to multiple unspecified patients who were administered vaccines which were stored improperly. This report refers to the patients who on unknown dates were vaccinated with VAQTA that were stored improperly. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
ON 12-30-19, PATIENT CALLED PHARMACY IN THE MORNING  AND TOLD PHARMACIST SHE HAD A REACTION TO THE VACCINE IN HER RIGHT ARM. PATIENT SAID SHE HAD A SIMILAR REACTION A FEW YEARS BACK TO A FLU SHOT. PATIENTS ARM HAD PAIN AT THE INJECTION SITE FOR A FEW DAYS, AND HAD PROGRESSING REDNESS AND ITCHING IN AN OVAL SHAPE, NO SWELLING, FROM HER SHOULDER TO HER ELBOW. PATIENT  WAS CONTACTED  SAME NIGHT AT 6:50PM. PATIENT SAID SHE HAD GONE TO HER DOCTOR, AND THE DOCTOR WAS NOT CONCERNED SINCE SHE HAD A SIMILAR REACTION BEFORE. DOCTOR TOLD PATIENT TO USE A MOISTURIZER TO HAVE THE REDNESS AND ITCHING FADE.
Malaise & fatigue onset 2 days after vaccination. 3 days after vaccination had severe generalized muscle cramping. Fatigue & muscle pain resolving slowly nearly 4 weeks later.
fever 104, sore throat, enlarged lymph node; general malaise; seen by MD;
Pt is 36 year old female who was reported as having local reaction to her 5th Anthrax shot. There was erythema and swelling approximately 18cm in diameter at injection site. Symptoms progressed over 3 days. Pt reported redness, warmth to touch and stabbing pain with indurated area at injection site. Treatment was cold/warm compression applications and prescribed 800mg ibuprofen and cyclobenzaprine.
30 minutes post vax the patient experienced itching, noticed a rash, and then felt her tongue getting thick. The patient was treated in the ER with an injection in the hip and was advised she probably had a reaction to some component of the vaccine.