chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effects reported; Multiple patients were vaccinated with improperly stored ROTATEQ on multiple dates; Information has been received from a medical assistant concerning a patient of unknown age, gender and race. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 29-JAN-2019, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally for prophylaxis (lot number R021055 with expiration date in 01-APR-2020) (strength and anatomical location were not provided).  The Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was stored at an unknown temperature for an unknown time frame. There was a previous temperature excursion and the call was because of a data logger.  No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA001848: US-009507513-1907USA001849: US-009507513-1906USA011434: US-009507513-1907USA001793: US-009507513-1907USA001794: US-009507513-1907USA001795: US-009507513-1907USA001796: US-009507513-1907USA001797: US-009507513-1907USA001798: US-009507513-1907USA001799: US-009507513-1907USA001800: US-009507513-1907USA001801: US-009507513-1907USA001802: US-009507513-1907USA001803: US-009507513-1907USA001804: US-009507513-1907USA001805: US-009507513-1907USA001806: US-009507513-1907USA001807: US-009507513-1907USA001808: US-009507513-1907USA001809: US-009507513-1907USA001810: US-009507513-1907USA001811: US-009507513-1907USA001812: US-009507513-1907USA001813: US-009507513-1907USA001814: US-009507513-1907USA001815: US-009507513-1907USA001816: US-009507513-1907USA001817: US-009507513-1907USA001818: US-009507513-1907USA001819: US-009507513-1907USA001820: US-009507513-1907USA001826: US-009507513-1907USA001822: US-009507513-1907USA001823: US-009507513-1907USA001824: US-009507513-1907USA001825: US-009507513-1907USA001827: US-009507513-1907USA001828: US-009507513-1907USA001829: US-009507513-1907USA001830: US-009507513-1907USA001831: US-009507513-1907USA001832: US-009507513-1907USA001833: US-009507513-1907USA001834: US-009507513-1907USA001835: US-009507513-1907USA001836: US-009507513-1907USA001837: US-009507513-1907USA001838: US-009507513-1907USA001839: US-009507513-1907USA001840: US-009507513-1907USA001841: US-009507513-1907USA001842: US-009507513-1907USA001843: US-009507513-1907USA001844: US-009507513-1907USA001845: US-009507513-1907USA001846: US-009507513-1907USA001847: US-009507513-1907USA000952: US-009507513-1907USA000989: US-009507513-1907USA000962: US-009507513-1907USA000988: US-009507513-1907USA000963: US-009507513-1907USA000953: US-009507513-1907USA000959: US-009507513-1907USA000968: US-009507513-1907USA000967: US-009507513-1907USA000964: US-009507513-1907USA000966: US-009507513-1907USA000954: US-009507513-1907USA000969: US-009507513-1907USA000970: US-009507513-1907USA000965:
Appendicitis; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in the left arm on 26Mar2021 at 15:15 (batch/lot number was not reported) as a single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient has no known allergies. The patient was not pregnant at the time of vaccination. Facility type vaccine was public health clinic/veterans administration facility. Concomitant medication included omeprazole (PRILOSEC) taken for an unspecified indication, start and stop date were not reported. Historical vaccine included BNT162B2 first dose on 05Mar2021 at 14:45 in the left arm for COVID-19 immunisation (batch/lot number was not reported). The patient experienced appendicitis the following Tuesday (as reported), reported start date was on 29Mar2021 at 12:00. The adverse event resulted in emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). The patient was hospitalized for appendicitis for 3 days. Therapeutic measures were taken as a result of appendicitis which included appendectomy. No Covid prior to vaccination. Patient was Covid tested post vaccination. Covid test type post vaccination was nasal swab on 30Mar2021 with negative result. The outcome of the event was recovering.
No AEs reported; expired VAQTA was administered; This spontaneous report was received from a medical assistant and refers to a 15 months old patient of unknown gender. There was no information regarding their medical history, concurrent conditions nor concomitant therapies provided.  On 23-AUG-2021, the patient was vaccinated with an expired dose of hepatitis A vaccine, inactivated (VAQTA) lot # T008698, expiration date 04-JUN-2021 (dose, route of administration and anatomical location were not provided) for prophylaxis (expired product administered). The administered vaccine was not involved in a temperature excursion. No adverse events (AEs) were reported.  This is one of three reports from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: devicelotnumber: T008698; expirationdate: 04-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability; Sender's Comments:  US-009507513-2109USA005193: US-009507513-2109USA005135:
Within 6 hours after the vaccination, I developed a fever. 99, started taking Ibuprofen and by midnight it was 104.8. Called the answer service and doctor said it was normal. By 04:00am, the fever was reduced did not feel right. Sodium was low and other electrolytes was off and was preparing for overnight stay and was discharged by 07:00PM 12 hours in ER. Sodium level was discharged on 11/01/2021 discharged 11/05/2021 PCP visit and evaluation and sodium level test.
sore arm, body aches, extreme fatigue, headache, grogginess, slight headache slightly upset stomach ache, no appetite, general sense of feeling very poorly.
Aprrox 30 to 45 mins after receiving the first vaccine I ws driving and I felt like I had a buzz from drinking or a high and it has not gone away.  I now have tinnitus  which started 2 days ago
Received 2nd booster - patient came in and reported extreme bruising and swelling at injection site (about 2-3 inches in diameter) patient also reported pain in lower limbs that improved with walking. She said she would go to the ER/seek help if she noticed any bruising in her legs as she had not yet checked when she reported to the pharmacy.
I woke up with a fever and it was pretty high. 102.3. I had really bad body aches and a little bit of a headache. Really bad pain in hip joints and body aches and the fever continued into the third day - it was down to 100.5 in the morning and then it went away in the afternoon.  The body aches lasted through the 2nd day. I took ibuprofen and that helped with the symptoms. I had called Caregiver health line on the 3rd day because I missed work because I still had a fever.
Left arm/face swelling; Face swelling; numbness; Neausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Jul2022 at 15:15 as dose 1, single (Lot number: FM9992) at the age of 38 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Pen" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: SWELLING FACE (non-serious) with onset 13Jul2022 at 15:15, outcome "recovering", described as "Face swelling"; PERIPHERAL SWELLING (non-serious) with onset 13Jul2022 at 15:15, outcome "recovering", described as "Left arm/face swelling"; NAUSEA (non-serious) with onset 13Jul2022 at 15:15, outcome "recovering", described as "Neausea"; HYPOAESTHESIA (non-serious) with onset 13Jul2022 at 15:15, outcome "recovering", described as "numbness". Therapeutic measures were taken as a result of peripheral swelling, swelling face, hypoaesthesia, nausea.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination.
Patient experienced syncope withing 5 minutes of receiving injection.  Patient remained is sitting position after injection.  Patient placed in recovery position.  After regaining consciousness the patient ate crackers and juice.  Patient stayed in office resting times 20 minutes after regaining consciousness.  Per mother the patient had a extended football practice that morning and may of had mild dehydration.
No further AE's reported; administration of an improperly stored dose of ROTATEQ; This spontaneous report was received from vaccine coordinator referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not provided.  On 08-FEB-2022, the patient vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (product storage error) (oral liquid, orally, lot number 1742463, expiration date 20-SEP-2022, vaccination scheme, and anatomical location of vaccination were not reported) for prophylaxis. The vaccine was stored for the time frame of 9 hours 2 minutes in the temperature of following: above 47 degree F (80.8F) for 6 hours, above 47 degree F(61.9F) for 1 hour 10 minutes, above 47 degree F (53.2F) for 1 hour 15 minutes, above 47 degree F (51.8F) for 37 minutes. There was no previous temperature excursion.  No product quality complaint (PQC) and no further adverse event (AEs) (no adverse event) was reported.
Presented to the ED from NH for concerns of increased shortness of breath and fatigue for two days. History is unable to be obtained from patient due to dementia. Per NH, patient has not been febrile, had any nausea, vomiting, on constipation, but patient has had loose stool and a dry cough since admission 8/14. Patient's daughter states that patient has is DNR/ DNI. Was vaccinated, but unsure which vaccine.    Vital signs remarkable for SpO2 96% on HHF. Labs remarkable for potassium 2.8, BUN 23. ABG with PO2 62.4, PCO2 36.6, bicarb 29.8, pH 7.51. UA with 3+ esterase and WBCs, mucous and epithelial cells. CXR with left lower lobe pneumonia vs atelectasis, cardiomegaly is unchanged. Started on dexamethaone, remdesivir, ceftriaxone and doxycycline. Patient with increasing oxygen requirements on optiflow, patient's daughter made comfort care 9/7 given poor prognosis.
LT LEG INJECTION SITE FOR KINRIX (DTAP AND IPV) HAS A SOFTBALL SIZE LUMP THAT IS HARD, RED, PAINFUL AND PATIENT WILL NOT WALK OR USE THAT LEG. SHE IS VERY UNCOMFORTABLE AND CRYING.
Patient c/o of a very sore arm, with a LOM. She has improved slightly.
Employee developed lesions on pharynx and at the side of tongue with lymphadenopathy.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 02-MAY-2015, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 13-APR-2016, the patient was treated for a blistering vesicular outbreak and decreased immune symptoms which was then diagnosed as herpes zoster, or shingles. The patient was prescribed acyclovir and was administered an unspecified steroid injection for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events is unknown. Additional information has been requested.
General malaise with headache starting about an hour after injection. Eight hours after injection muscle and joints ache and started to run a fever. Took naproxen 220 mg at 1800 hrs. Woke up next day feeling like I had the flu and running a temp. of 101F. Took Acetaminophen 500mg. 0800 hr and 1400 hr and remained in bed still running a fever. By 1700 hr fever gone and felt much better. Injection site remains painful and warm to touch at 1000 hr 8/17/18. (No signs of infection).
Temperature excursion of vaccine; This spontaneous report was received from a nursing assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported.   On 11-AUG-2020, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) 1 dose, for prophylaxis, lot # S038698 and expiration date reported as 01-DEC-2021 (strength, frequency and route of administration were not reported).  The temperature exursion was reported as -10.°C, on a time frame of 1 hour and 53 minutes. There was no previous temperature excursion.   A digital data logger was involved.   This is one of several reports received from the same souce.; Sender's Comments:  US-009507513-2008USA014798: US-009507513-2008USA014950: US-009507513-2008USA014951: US-009507513-2008USA014705: US-009507513-2008USA015035: US-009507513-2009USA000113: US-009507513-2009USA000117: US-009507513-2009USA000132: US-009507513-2008USA014806: US-009507513-2008USA015018: US-009507513-2008USA014901: US-009507513-2008USA014937: US-009507513-2008USA014697: US-009507513-2008USA014705: US-009507513-2008USA014757: US-009507513-2008USA014803: US-009507513-2008USA014825: US-009507513-2008USA014888:
had 2 shots, have it on face/suspected vaccination failure; have it on face urge to scratch; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: had 2 shots, have it on face/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: have it on face urge to scratch). 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 and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 13-MAR-2023 The case was received from the patient interactive digital media. The patient had the 2 Shingles shots and shingles appeared on his/her right side of face from what he/she had been reading.  The patient would be going to the physician tomorrow.  The patient was fighting the urge to scratch.  The patient's husband got poison oak medicine it helped some what. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
got doses out of the box of expired tenivac single-dose syringes with no adverse event; Initial information received on 15-Aug-2022 regarding an unsolicited valid non-serious case received from a pharmacist. Agency Inquiry Number: 01235545  This case involves a 27-year-old male patient who got doses out of the box of expired Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac] single-dose syringes with no adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. This case is linked to cases 2022SA342354, 2022SA341716, and 2022SA340696.  On 05-Aug-2022, the patient received suspect Tenivac single-dose syringes at dose 0.5ml once via intramuscular route in the left deltoid (lot U5856AA, expiry date: 26-Jan-2022) for immunization (expired product administered) same day latency. No adverse event was reported.  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the 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.
Approx 6 hrs p/receiving flu shot devel sl pain on outside of lt ear & sl difficulty moving lt side of face; next morning lt side of face partially paralyzed down to about jaw line; dx Bell's Palsy by MD;
spotting : menstrual period; heaviness: menstrual period; This spontaneous case was reported by a consumer and describes the occurrence of INTERMENSTRUAL BLEEDING (spotting : menstrual period) and HEAVY MENSTRUAL BLEEDING (heaviness: menstrual period) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced INTERMENSTRUAL BLEEDING (spotting : menstrual period) and HEAVY MENSTRUAL BLEEDING (heaviness: menstrual period). At the time of the report, INTERMENSTRUAL BLEEDING (spotting : menstrual period) and HEAVY MENSTRUAL BLEEDING (heaviness: menstrual period) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 25-Feb-2021: follow up added
they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7168B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date).    Concomitant medications were not reported.                                       No treatment information was provided by the reporter.
chills; fever; nausea; Headache; flu-like symptoms; Fatigue; Left arm hurts; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th July 2019, the patient received the 1st dose of Shingrix (intramuscular). On 28th July 2019, less than a day after receiving Shingrix, the patient experienced pain in arm. On 29th July 2019, the patient experienced chills, fever, nausea, headache, influenza-like symptoms and fatigue. The patient was treated with ondansetron. On 30th July 2019, the outcome of the chills, nausea and headache were resolved with sequelae. On 31st July 2019, the outcome of the fever, influenza-like symptoms and fatigue were resolved with sequelae. On an unknown date, the outcome of the pain in arm was recovering/resolving.   It was unknown if the reporter considered the pain in arm, chills, fever, nausea, headache, influenza-like symptoms and fatigue to be related to Shingrix.  Additional details were received as follows: The patient experienced multiple adverse events as pain in arm, chills, fever, nausea, headache, influenza-like symptoms and fatigue. Patient stated that had severe nausea and had to take ondansetron on 29th July 2019, just for one day The batch number was not provided. The patient did not consent to follow up.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 10Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "heart disease" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; ELIQUIS; LISINOPRIL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid.  Additional information: I felt better taking paxlovid but got covid again 6 days after last dose. Treatment: Anti-viral details: [{product=COVID 19 Treatment, brand=Paxlovid, treatment start date=16May2022, treatment stop date=20May2022, indication=Treatment of COVID-19}]. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medication details: (other medication in 2weeks product=Eliquis, Lisinipril and Atavastin)   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.