chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 06Feb2021 at 10:00 as dose 1, single (Lot number: EL3247), in left arm, on 01Mar2021 at 10:00 as dose 2, single (Lot number: EN6200), in left arm, on 26Nov2021 at 10:00 as dose 3 (booster), single (Lot number: FH8030), in left arm and on 02Apr2022 at 10:00 as dose 4 (booster), single (Lot number: FK9894) at the age of 65 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: TADALAFIL, start date: 01Apr2020. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive, notes: Continue to test COVID positive on home antigen test (Day 11). Therapeutic measures were taken as a result of vaccination failure, covid-19. Additional information: COVID symptoms resolved 3 days after being on Paxlovid (Day 3). COVID Rebound began 3 days after finishing 5-day course (Day 8 of infection). With runny nose, cough, malaise. Temperature beginning to rise 6 days after ending 5-day treatment (Day 11) currently 99.9. Continue to test COVID positive on home antigen test (Day 11). No known allergies. No treatment AE.  No follow-up attempts are possible. No further information is expected.
wheezing/ shortness of breath and vomiting--started after 20 minutes of vaccination and later headaches, fatigue
This spontaneous report received from a physician concerned a 73 year old male. The patient's height, and weight were not reported. The patient's past medical history included anaphylactic shock (black widow bite), and concurrent conditions included allergy to scallops, and allergy to insect bite. The patient had no allergies to medication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported,1 total, administered on 18-MAY-2021 10:00 to left deltoid for prophylactic vaccination. No concomitant medications were reported.  On 18-MAY-2021, the patient felt some redness, irritation, warmth and soreness at injection site for about an hour afterwards and also experienced a brief fever from 18:00 on the day of vaccination which disappeared by the next morning. The patient also had some intestinal flu symptoms, muscle cramps and triple urinary output for about 72 hours post vaccination and he mentioned that the muscle cramps started around injection site and moved gradually down until it reached his lower extremities. Patient also experienced narcolepsy and said that the episodes would last either 90 minutes or 3 hours and would happen periodically for about 60 hours post vaccination and patient also said narcolepsy episodes would show up without any warning. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from narcolepsy, muscle cramps started around injection site and moved gradually down to lower extremities, intestinal flu symptoms, and triple urinary output on 21-MAY-2021, injection site irritation, injection site warmth, injection site soreness, and injection site redness on 18-MAY-2021, and fever on 19-MAY-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210708286-covid-19 vaccine ad26.cov2.s-narcolepsy. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
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. The patient's healthcare provider recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about October 2016, a pharmacist at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about October 2016, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Within a minute began vomiting. Erythema present on bilateral arms. Vitals signs WNL. No hives/swelling. Erythema resolved within 5 minutes. Assessed by MD to be vasovagal reaction. No treatment. Vitals signs remained stable after 30 minute monitoring period.
Guillain Barre. She was well on day of immunization but later said she was weak and several months this was not objectively noticed then, but shortly after the vaccine. 9/28/06 Received medical records from neurologists which reveal patient seen by PCP 7/31/06 with complaint of loss of strength over past 3 mos.  Labs were done by PCP & showed mild dehydration & elevated neutrophils, eos were absent.  Patient referred to neuro & initial eval on 8/3 reveals patient noted weakness beginning in June which had progressively worsened.  Symptoms included tingling sensation at tip of fingers & significant weakness to the point she could not do her own hair.  Birth history was WNL & only PMH is of ADD & has been on Adderall for about 1 year as well as BCP.  Exam showed definite weakness of all extremities, esp upper extremities, & neck.  Reflexes were absent in legs.  Gait was normal but had difficulty taking steps w/o support & could not rise from sitting w/o help.  Normal CPK made dx difficult & EMG/NCS was done on 8/4 which was strongly positive for GBS & copy of test included with records.  Treated with IVIG x 2 days & placed in rehab facility on 8/5/06 for eval & therapy then received home PT.  Seen by neuro next on 8/24 which showed improvement but still with weakness especially in the hands.  Now able to rise from sitting on floor w/o support.  Still no reflexes in legs.  Complete but slow recovery was expected at that time/ss 9/28/06 Received medical records from hospital which reveal patient admitted 8/4/-8/6/06 for IVIG & PT./ss
Pt experienced flushing and hot flash's heaad to toe with a racing heart. Pt given water and snack. Symptoms resolved in 15 minutes.
Patient received vaccine at school. <5 minutes after shot patient had hives head to toe. No itching noted, BP 114/70 HR 110 Resp. 26 No swelling of throat. EMS observing patient 2 tsp. Benadryl given at 11:45 am. Mother and grandmother called. 12:15 pm patient to classroom observed. No SOB red blotches diminishing. Grandmother picked up patient and given instructions to take him to the ER if any signs of SOB occur. Grandmother voiced understanding.
they have mistakenly administered an expired Daptacel to a patient, with no reported adverse event; Initial information received on 30-Jun-2023 regarding an unsolicited valid non-serious case received from a non-healthcare professional.  This case involves a 1 years old male patient and it was reported they have mistakenly administered an expired diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] to a patient, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB vaccine CONJ (TET TOX) (ACTHIB); and pneumococcal vaccine CONJ 13V (CRM197) (Prevnar 13) both for Prophylactic vaccination..  On 30-JUN-2023, the patient was mistakenly administered an expired dose (Dose 4) of diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] Suspension for injection (batch/lot number: C5893AA; expiry date: 21-Jun-2023; strength: standard; frequency: once) via intramuscular route in the left thigh for immunization, with no reported adverse event (expired product administered) (latency: same day).  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.
***VACCINE ADMINISTRATION ERROR****** PATIENT WAS GIVEN THE MODERNA BOOSTER (0.25 mL, INTRAMUSCUARLY IN THE LEFT ARM) TWO MONTHS TWO EARLY.  THE PATIENT WAS CONTACTED IMMEDIATELY WITH THE ASSISTANCE OF AN INTERPRETER UPON DISCOVERY OF THIS ERROR DURING CHARTING AND DENIED HAVING ANY CONCERNS OR HAVING EXPERIENCED ANY ADVERSE EVENTS THUS FAR.
This case was reported by a consumer and described the occurrence of fever in a 3-year-old female subject who was vaccinated with Havrix, for prophylaxis. The reporter is the mother of the subject. A physician or other health care professional has not verified this report. On 13 September 2006 the subject received 1st dose of Havrix. The consumer  reported that no other vaccinations were administered on 13 September 2006. "About a day later, " on an unspecified date in September 2006, the subject experienced fever. The subject seen in an emergency department. At the time of initial reporting, 22 September 2006, the outcome of the fever was not reported.
Redness and swelling, oval darker ring around outer border 4inches by 2 inches, around injection site 8 days after injection. Presented as itchy and now is localized muscle soreness
Muscle pain, weakness, fever (102), lymphadenopathy, tonsillitis, improved next day with Abx.
Feels like going to bed and cover up; Chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feels like going to bed and cover up) and CHILLS (Chills) in a 95-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 069F21A, 029L20A and 031M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, the patient experienced FEELING ABNORMAL (Feels like going to bed and cover up) and CHILLS (Chills). At the time of the report, FEELING ABNORMAL (Feels like going to bed and cover up) and CHILLS (Chills) outcome was unknown.            No concomitant and treatment information were reported by the reporter  It was reported that patient had not called the doctor / nurse. Patient had not taken any medicine yet.
Received shot at 9:15 AM Oct 28, 2010 at 5:15 same evening started getting fever & sore throat then at 7:50 pm same evening, started throwing up. Done same way until I got some BACTRIM DS Tabs in me then Wed started losing my voice throwing up, chills & coughing here Nov 8, 2010 am still same way.
Doses administered past the 30-day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the 30-day use by date) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    In February 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered past the 30-day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter. Patient took booster dose. On 14-Jan-2022 the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions. No treatment medication was reported by reporter.
refrigerator containing Fluzone went down to 29.1F. After that excursion, vaccine administered to patient / no AE; Initial information received on 07-Feb-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2020SA032577, 2020SA038302, 2020SA038467, 2020SA038474, 2020SA038473, 2020SA038466, 2020SA038472, 2020SA038343, 2020SA038344, 2020SA038345, 2020SA038346, 2020SA038347, 2020SA038348, 2020SA038349, 2020SA038350, 2020SA038351, 2020SA038352, 2020SA038468, 2020SA038469 and 2020SA038470.  This case involves a 08 years old male patient who received 0.5 ml dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] lot UJ254AC (Expiry date 30-Jun-2020) via unknown route in the left deltoid for Prophylactic vaccination on 16-Jan-2020 which was exposed to refrigerator down to 29.1F.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to Product storage error temperature too low.  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder 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.
Patient only received a partial dose of Flulaval prefilled syringe. Per CDC guidelines a full dose was administered immediately afterwards.
Administer expired vaccine to patient, after the manufacture date of expiration 09-Nov-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration 09-Nov-2021) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration 09-Nov-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration 09-Nov-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported.  Date the vial was initially stored in the refrigerator reported as unknown. Number of doses/vials was reported as 168 doses.  Dates of administration of vaccine were reported as 10-Nov-2021 and 11-Nov-2021.  The vial did not undergo any temperature excursions.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received contains non-significant information.
A non-serious spontaneous report of twenty-eight patients received expired FLUMIST was received from a health professional concerning a ten-year-old male. Neither the patient's past medical history nor the concomitant medications were reported. The product expired on 20-Feb-2011. The patient received the expired FLUMIST on 01-Mar-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
Prolonged tinnitus primarily in left ear. Continuous occurrence seeming to coincide with administration of second dose of COVID-19 vaccine.
pt woke up and stated that her arm felt like it was asleep , but then she realized that she couldn't move it. Went to her PCP and PCP referred her to ER.  At ER, dr gave rx for muscle relaxant and diclofenac.  She was told to wait four days and if no better go back to dr or return sooner to dr if worse.
Information has been received from a physician concerning a 19 year old female with no known drug allergies, who on 20-AUG-2007 was vaccinated with Gardasil (lot # 658282/0929U). Prior to administration of Gardasil, the patient was given a TB test, blood was drawn and ADACEL was given in the right arm. The patient received Gardasil and became light headed, fell forward off the exam table and hit her head on the floor. The patient's eyes rolled back and there was brief seizure activity and foaming at the mouth. The patient had an abrasion on the nose from the fall and a bump/swelling on the top of the head. The patient complained of pain in the left wrist. The patient was taken to the emergency room and a CAT scan was found to be "okay" and no bloodwork was done. The patient was diagnosed with a mild concussion and was released from the emergency room. The patient was seen in the office on 22-AUG-2007 and the swelling on the forehead improved and the patient was recovered (also reported as recovered on the night of 20-AUG-2007. Upon internal review, brief seizure activity was determined to be an other important medical event. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not reported. On 28-JUL-2016, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB (dose and route were unknown, lot # M007763, expiration date 15-SEP-2017), which was exposed to temperature excursion of 49 degrees Fahrenheit (F) for 64 hours. There was no previous temperature excursion. Data logger was not involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a physician concerning a 2 month old patient who was vaccinated with a dose of Rotateq. Concomitant vaccinations included "other childhood vaccines". It was reported that the patient experienced a mild seizure. No other information was provided. Upon internal review the patient's experience was considered to be an other important medical event. Additional information is not expected.
arm is black; 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 SKIN DISCOLORATION (arm is black) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SKIN DISCOLORATION (arm is black). At the time of the report, SKIN DISCOLORATION (arm is black) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported  No treatment drugs were reported     Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: No specific follow-up information recorded.
This spontaneous report has been received from a nurse practitioner concerning an unspecified number of patients of unknown age and gender. The patients' concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On unknown dates, the patients were vaccinated with Dose 2 or Dose 3 GARDASIL (route, lot # and expiration date not reported) late( inappropriate schedule of drug administration). No symptoms were reported. Additional information has been requested.
Started the evening of 1/20/2020.  Complains of 2.8cm rash superior to injection site with tingling sensation.  Erythema, tenderness noted, with a couple of smaller patches of erythema several centimeters below site. Rashes are slightly indurated.  Denies any other symptoms.  Pt seen by physician and instructed to take Loratadine 10mg PO daily, HC cream 1% 1-2x daily.  Told by physician that she is allergic to Shingrix and should not have the second dose. Pt has a history of Shingles July 2019.
Heavy vaginal bleeding, mostly brown in color to start with red blood periodically, then turning into heavy vaginal bleeding. Unlike menses, no cramps as of yet, just heavy vaginal bleeding. Menses are normally very regular. My arm at the injection site is also extremely painful and swollen. I?ve never reacted that way to a vaccine.
Left arm sore at injection site Left eye and cheek swelling, redness, and heat Fever of 99.6 degrees  Started around 9:00pm on 04/03/2021
Patient vaccinated with Pfizer at 11:03 am and started to exhibit symptoms at 11:08. Patient had cold, clammy skin and tingling in both hands. Vitals were 120/80; HR 52; R 17; SAT 100% on RA.
Extreme fatigue/tiredness, fever, chills, nausea  and sore throat
rash above my upper lip, rash on my face, fever blisters on both lips, swelling of the face and neck, lasting for weeks. I am still experiencing minimal effects of the Vaccination after almost 5 weeks.