chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This medically confirmed spontaneous report (initial receipt 01-Sep-2015) concerns a 46-year-old female patient. On 01-Sep-2015, the patient inadvertently received an intramuscular dose of expired AFLURIA (batch number T53909, expiry date: 30-Jun-2015) at a dose of 0.5 ml, which was medication error. No adverse reaction occurred after the administration. The outcome was reported as recovered. Reporter's outcome: The reporter assessed the event as non-serious. Additional information was received from the reporter on 01-Dec-2015: The reporter assessed the event as unrelated to AFLURIA.
About two weeks after vaccination I noticed my heart beat was irregular.  The episodes we initially short, 3-5 minutes.   After 4 weeks, the episodes lasted longer, up to 3 to 4 hours.  On April 27th, I was taken by ambulance to the Emergency Room as I was in AFIB.
Muscle and joint weakness with chest muscle pain x 5 days hurts all over and worse when gets up and moves. Diarrhea started 1-5-2021. No fever 97.7. Off work for 4 days. Using heating pad and inhalers. Has appointment with provider 1-5-2021 and 1-7-2021. Test for COVID on 1-7-2021 and negative Symptoms resolved 1-9-2021 and returned to work on 1-11-2021
issues with numbness; issues with circulation in/around the injection site; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (issues with numbness) and VACCINATION SITE REACTION (issues with circulation in/around the injection site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (issues with numbness) and VACCINATION SITE REACTION (issues with circulation in/around the injection site). At the time of the report, HYPOAESTHESIA (issues with numbness) and VACCINATION SITE REACTION (issues with circulation in/around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Information was received from a physician referring to a 3 months old patient of unknown gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On an unknown date the patient was administered 0.5 ml VARIVAX (unspecified lot and expiration date) subcutaneously. No adverse effect was reported. Additional information has been requested.
Had an Ear Ache and went to Urgent Care, they tested me for COVID-19 and I was positive. For the ear infection I was given Azithromycin.
nausea (gagging), headache, fatigue, feeling hot (no fever).  Symptoms started the same evening I received the shot, am now on day 4 and symptoms have eased up, but still present.
This spontaneous report as received from a medical assistant refers to a male patient of unknown age. Medical assistant reported that on 22-OCT-2013 the patient was administered PNEUMOVAX 23 (lot number, dose and route were not reported). Concomitant medications were not reported. On an unspecified date, in October 2013, the patient developed redness and arm swelling in the arm she received the routine immunization. The outcome of redness and arm swelling was not reported. The relationship between the PNEUMOVAX 23 and the events was not reported. This case is linked to case 1310USA011956 via same reporter link. Additional information has been requested.
This spontaneous report as received from an approximately 60-year-old female registered nurse regarding herself. Current conditions included diabetes, asthma, kidney issues, hypothyroidism, macular degeneration in eyes, pituitary tumor on an unknown date in January 2009, arthritis, on an unknown date in September 2011 the nurse had blood coming out during urination and was diagnosed with a kidney infection. Patient was allergic to penicillin and sulfa. Lab tests included kidney sonogram done on an unknown date in October 2011. On 12-JAN-2012 the patient was vaccinated with dose 1 PNEUMOVAX23 (lot # not reported) dose and route not reported. Concomitant medications included 2 types of unspecified INSULIN, SYNTHROID and 12 other unspecified medications. The nurse was very sick (disability), had a fever (disability) and bad lung condition (disability) that occurred on an unknown date early in April 2012. She went to the physician office on 12-APR-2012 and was given dose 2 PNEUMOVAX23 (lot# not reported) dose and route not reported. The nurse was given prednisone and other unspecified medications and then recovered on approximately 03-MAY-2012 (2.5-3 weeks after visit on 12-APR-2012). She mentioned that recently she had been experiencing dizziness (disability). She did not know if this was related to her ear problems (disability) she got a lot or because of receiving 2 doses of PNEUMOVAX23 within a short time of each other. The outcome of the events dizziness and ear problems were unknown. The patient sought medical attention for the events by visiting the office. The event a lung condition was considered life threatening by the reporter. This is one of the 2 reports from the same reporter and patient. The events were considered to be other important medical events. Additional information has been requested.
Local non indurated itchy blanching red rash which improved with BENADRYL developed 2 days after vaccine at site of DTaP-IPV.
body aches; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches), CHILLS (chills) and HEADACHE (headache) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     Concurrent medical conditions included Pollen allergy. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced MYALGIA (body aches), CHILLS (chills) and HEADACHE (headache). The patient was treated with IBUPROFEN ongoing from 24-Mar-2021 at a dose of UNK UNK, bid and AMOXICILLIN ongoing from 24-Mar-2021 at an unspecified dose and frequency. At the time of the report, MYALGIA (body aches), CHILLS (chills) and HEADACHE (headache) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, SARS-CoV-2 test: positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Pt recv vax on 1/27/99; on 1/30/99 pt exp red, warm vax site, nausea, fever (101), malaise; tx=Benadryl & Phenergan
swelling and rash from her elbow-up in the arm of the injection site; swelling; rash from her elbow-up in the arm of the injection site; Initial information received on 18-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 74 years old female patient who experienced swelling and rash from her elbow-up in the arm of the injection site (vaccination site inflammation), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 10-Nov-2018, the patient received a dose of suspect 0.5 ml INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ052AA and expiry date: 09-Jun-2019 via unknown route in left arm.  On 18-Oct-2019, 11 months 8 days after the vaccination the patient experienced swelling and rash from her elbow-up in the arm of the injection site (vaccination site inflammation) with symptoms swelling (vaccination site swelling) and rash from her elbow-up in the arm of the injection site (vaccination site rash).  (Other relevant tests included no lab data.)  Final diagnosis was vaccination site inflammation.  It was not reported if the patient received a corrective treatment.  The outcome of the events was reported as recovered on an unknown date.; Sender's Comments: .   Initial information received on 18-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 74 years old female patient who experienced swelling and rash, while she using with the use of medical device FLUZONE HIGH DOSE IM PRE-FILLED SYRINGE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient started using FLUZONE HIGH DOSE IM PRE-FILLED SYRINGE dosage unknown (lot - #UJ052AA, 09-Jun-2019) for Immunisation.  The patient developed an event of a non-serious swelling (extensive swelling of vaccinated limb) Unknown latency after starting use of FLUZONE HIGH DOSE IM PRE-FILLED SYRINGE. The patient developed an event of a non-serious rash Unknown latency after starting use of FLUZONE HIGH DOSE IM PRE-FILLED SYRINGE.   Final diagnosis was rash and swelling.    An unknown corrective treatment was received.  The patient outcome is reported as Recovered / Resolved on an unknown date for swelling and as Recovered / Resolved on an unknown date for rash.
The patient developed a raised linear pattern of hives on her left forearm - measuring approx. 2 1/2" in length with erythema along with an area of raised erythema close to her left wrist - palmar Aspect. Received Benadryl 25 mg syrup po at 1427. Vitals at 1438 = P 125, B/P 195/119, O2 Sat 99% on RA. At 1438 patient noted with Raised linear hive with surrounding erythema approx 3/4" long above (L) eyebrow. Given Benadryl 25mg syrup po. at 1438. Vitals repeated At 14:35 patient assessed. No swelling noted of lips, tongue or elsewhere in mouth. Talking without difficulty. Swallowing + breathing without problem. Cardiac - S1S2 RRR. 0 murmurs noted. Chest - CTA Bilat + NL. vitals repeated at 1445 and B/P 179/116, HR - 63, O2 sat 98% on RA. vitals repeated at 1500 and B/P 167/100, HR 64, O2 sat 98% on RA. Patient reporting B/P at Baseline. By 1500 on 1/8/2021 All raised erythematous areas above Right eyebrow, on left wrist + Left forearm resolved. Patient reporting to feeling better. vitals repeated @ 1525 and B/P 175/103, HR 52 and O2 sat 95% on RA. Patient remains Asymptomatic, no new hives or red patches noted. Breathing without difficulty. No swelling of lips, tongue or elsewhere in mouth observed. Answering questions appropriately. Patient met with unit supervisor and given the "ok" to return to unit. It was explained to patient that should her symptoms return to notify unit nursing staff + seek medical care.
Vaccine that administered beyond use date after the thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.  On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 28-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  The patient did not experience any adverse reactions after the administration of vaccine.  On 10-Jun-2022 the vaccination facility was made aware of administration of vaccines beyond use date after the thaw process while audit was conducted. Patient got Moderna with vaccine Ndc code.  No treatment information was provided by the reporter.
This case was reported by a pharmacist via call center representative and described the occurrence of bell's palsy in a 58-year-old female patient who received SHINGRIX (batch number DD43M, expiry date unknown) for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 30th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, the patient received the 2nd dose of SHINGRIX. On 8th March 2019, 190 days after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced bell's palsy (serious criteria GSK medically significant). On an unknown date, the patient experienced incomplete course of vaccination. The patient was treated with prednisone and valaciclovir (Valacyclovir). On an unknown date, the outcome of the bell's palsy was not recovered/not resolved and the outcome of the incomplete course of vaccination was unknown. It was unknown if the reporter considered the bell's palsy to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. Around 8th march 2019, the patient experienced Bells Palsy. On 8th March 2019, the patient was prescribed Prednisone 60 mg daily for 7 days and Valacyclovir 1 gram three times a day for 7 days.     Till the time of reporting, the patient did not receive 2nd dose of SHINGRIX, which led to incomplete course of vaccination. The pharmacist consented to follow up. This case has been linked to US2019063122, reported by the same reporter.
Mildly paranoid; Mild tremor; Slight balance problems; Allergic to encephalitis; Flu like symptoms that were mild in feeling; Night mares; A spontaneous report (United States) was received from a 75-years-old male Healthcare Professional who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events allergic encephalitis, flu like symptoms, nightmares, mild tremors, paranoia, and slight balance problems.   The patient's medical history was not provided. No relevant concomitant medications were reported.  On 27 Jan 2021, at 11:00 am, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection.  On an unknown date in Jan 2021, the patient developed events, mild flu like symptoms and nightmares. On 29 Jan 2021, the patient experienced the events mild tremorsr and paranoia. On an unknown date, the patient felt that he had allergic encephalitis and had slight balance problems. On an unknown date, when the patient woke up in the morning, he became paranoid and trimmer increased. The event allergic to encephalitis was considered as medically significant.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of events, flu like symptoms, night mares, mild trimmer, paranoia, allergic to encephalitis and slight balance problems was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Pt said she began to experience "arm pain" the evening she received the vaccine. She also says she is experiencing shoulder & neck pain. She had been to the doctor who prescribed her VOLTAREN topical gel for her shoulder and neck. Doctor was unsure if related to vaccine as per patient. Pt still complains of ongoing arm pain, neck & shoulder pain.
no adverse effect; The following 10 patients were administered the VAQTA Lot # S009943 that had undergone temperature excursion; This spontaneous report was received from an office manager concerning a 12-months-old male patient. The patient's concurrent conditions, medical history and drug reactions or allergies were not reported.  On 10-OCT-2019, hepatitis a vaccine, inactivated (VAQTA) experienced temperature excursion at -1.49ºC for a timeframe of three days. On 27-OCT-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) (lot # S009943 and expiration date: 26-JUL-2020) as prophylaxis (strength, route of administration and anatomical location were not reported) (incorrect product storage). On 31-OCT-2019, hepatitis a vaccine, inactivated (VAQTA) experienced another temperature excursion at 11.49ºC for a timeframe of fifteen minutes. There was no previous temperature excursion. The call was due to digital data logger.   No adverse effects were reported.  This is one of several cases received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; deviceage and unit: 0 ; malfunction: No; productavailableforevaluation: No; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-1911USA007567:
Patient presented to the emergency department on 08/28/2021 for evaluation of post cardiac arrest state that started prior to arrival.  Friends report patient was drinking a beer; he suddenly collapsed and then hit his head as he went down.  CPR was initiated by nursing students present; EMTs arrived on the scene very quickly and ACLS was initiated.  Patient was intubated/ventilated and sent to ED via ambulance.
Arm pain persisting since July 29th administration from the moment of injection in the left arm.
No adverse event reported by pt. RabAvert vaccine administered to gluteal muscle instead of deltoid muscle.
positive for COVID; positive for COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 21K-163-4035165-00.   A 53-year-old female patient received BNT162b2 (BNT162B2), on 04Aug2021 as dose 1, single (Batch/Lot number: unknown) at the age of 53 years and on 25Aug2021 as dose 2, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported.   The following information was reported: VACCINATION FAILURE (medically significant) with onset 16Sep2021, outcome "unknown", COVID-19 (medically significant) with onset 16Sep2021, outcome "recovered" and all described as "positive for COVID". The patient underwent the following laboratory tests and procedures: Blood test: (unspecified date) All good; SARS-CoV-2 test: (16Sep2021) Positive; (Nov2021) Positive.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
The shipment of vaccine was received outside 72 hour guideline and was potentially compromised, no AE; The shipment of vaccine was received outside 72 hour guideline and was potentially compromised, no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health professional via Health Authority (Reference number- 00303291) and transmitted to Sanofi on 06-Oct-2020.  This case is linked to cases 2020SA310350, 2020SA310351, 2020SA310352, 2020SA310901, 2020SA310354, 2020SA310460, 2020SA310461, 2020SA277871, 2020SA310463, 2020SA310464, 2020SA310555, 2020SA310556, 2020SA310557, 2020SA310558, 2020SA310559, 2020SA310704, 2020SA310705, 2020SA310706, 2020SA310707, 2020SA310708, 2020SA310759, 2020SA310760, 2020SA310761, 2020SA310762, 2020SA310763, 2020SA310764, 2020SA310765, 2020SA310766, 2020SA310767, 2020SA310768, 2020SA310769 and 2020SA310770 (same reporter).  This case involves a patient (demographics unknown) who was administered a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ505AA, expiry date: 30-Jun-2021, form: prefilled syringe) via unknown route in unknown administration site for prophylactic vaccination on 05-Oct-2020, whose shipment was received outside the 72 hour guideline and was potentially compromised (product storage error and product distribution issue).  It was a case of an actual medication error due to incorrect product storage.  It was also a case of product shipment delay.  The shipment of vaccines was received outside the 72 hour guideline for standard shipping. It was received in 76 hours. The practice was advised not to use any remaining stock as new stock will be replenished and to return the remaining stock. It was also advised to re-vaccinate the patients who had received a dose of the potentially compromised product. No thermometer was in packaging and product was cold when they received it.  At the time of report, no adverse event was reported.  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 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.
angioedema, throat tightness, chest tightness.  started five minutes after shot. lasted 3-5 hours iv benadryl, pepcid, and solumedrol given