chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recv vax 3AUG95 & devel t101;tx APAP;12AM pt t103;pt wrapped in room temp towels;7AM temp remained elevated 103;pt irritable & delirious;fluids administered;5AUG95 pt afeb upon awakening;APAP given later low grade temp
Information has been received from a physician concerning a 13 year old female with no pertinent medical history and no drug reactions/allergies who on 14-AUG-2007 was vaccinated with the first dose of GARDASIL. Immediately after receiving GARDASIL the patient vomited. Also, for six months thereafter, the patient periodically experienced dizziness, nausea and vomiting. The patient sought unspecified medical attention. At the time of the reporting, the patient had recovered. Additional information has been requested.
Patient complained of diaphoresis and light headedness about 5 minutes after receiving 2nd dose of Moderna Covid vaccine.  Patient was able to ambulate to cot.  Blood pressure, heart rate, and respirations all within normal limits.  Patient given water and observed for an additional 30 minutes.  All symptoms resolved.
patient being administered a vaccine post-excursion with no reported adverse event; Initial information received on 17-Oct-2023 regarding an unsolicited valid  non-serious case received from a physician.  This case is linked to case 2023SA322119(CLUSTER).  This case involves a 21 months old male patient who was administered a IPV (VERO) (IPOL) vaccine post-excursion (with no reported adverse event).  The patient's past vaccination(s) included PENTACEL. The patient's past medical history, medical treatment(s), and family history were not provided.  On an unknown date, the patient received dose 1 of 0.5 ml of suspect IPV (VERO) Suspension for injection (Batch number: W1A101M, expiry date: unknown strength: standard) via intramuscular route in the left thigh as Immunization  On an unknown date, the patient was administered a vaccine post-excursion (with no reported adverse event) (poor quality product administered) (Latency: same day)  It was reported" A doctor is reporting a temperature excursion that occurred one month ago and was advised to call us to determine if the vaccines are still viable for use. He also stated that the vaccines were used for three patients after the temperature excursion. Product/s: IPOL was Opened products and the reason: unknown Max temperature reached: 47.1°F Duration out of labelled range: 15 minutes Human error was unknown. The extended stability data did not cover the excursion. 3 patients were involved. Previous excursion: None. The patients were fine, and the reporter did not report any side effects."  Action taken was 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.
received dosis reconstituted with sterile water; received Menveo dosis reconstituted with sterile water; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 17-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA5H94, expiry date 23rd May 2023) for prophylaxis.   On an unknown date, the patient received Menveo (intramuscular) .5 ml. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 10-Aug-2022 Reporter's comment: The reporter reported that the vaccine was possibly reconstituted with sterile water instead of appropriate diluent. Error was discovered and reported when staff thought an empty box was in refrigerator. The date issue was identified was 8th June 2022 The patient could have received inappropriately reconstituted vaccine. Centers for disease control and prevention/GlaxoSmithKline advised to reimmunize the patient. It was a medication error without harm. The reporter consented to follow-up. Additional supportive information: The patient received the inappropriately reconstituted Menveo, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. This is 1 of 5 linked case, reported by same reporter, for different patient.; Sender's Comments:  US-GSK-US2022AMR117816:Same reporter US-GLAXOSMITHKLINE-US2022091409:Same reporter US-GSK-US2022AMR117821:Same reporter US-GSK-US2022AMR117819:Same reporter
Red lump with red (faint) streak down arm on Right arm when reported on 4/3 Patient updated office on 4/4 and had some improvement in redness at site but area still warm.
Plan: Due to positive home Covid test has been obtained in clinic and sent to the laboratory.  Mother has been counseled to continue to offer fluids as often as possible, alternate ibuprofen and Tylenol administration to keep the fever below 100.0 and to continue monitoring her urinary output to ensure she is not becoming dehydrated.  Tylenol has been administered in clinic with good effect.  Patient will follow-up as needed with her PCP.  Patient and mother have been sent home on quarantine orders until the results are known.  If results were to return positive we will inform the family and continue quarantine. Follow-up: No follow-up provider specified. Subjective: Patient ID:  Patient is a 11 y.o. female who presents today with a chief complaint of: Fever (9 Weeks To 74 Years) 11-year-old female patient presents to urgent care with an elevated temperature.  Mother states she had the second Pfizer Covid vaccine administered yesterday.  Patient has otherwise been in her normal state of health.  Due to the fever the mother performed a home Covid test which returned positive.  Mother is now concerned the patient may also be positive for Covid.  Mother denies recent fever, chills, cough prior to the Pfizer vaccine yesterday.
Female consumer states she has Covid and has been taking Paxlovid since Friday; Female consumer states she has Covid and has been taking Paxlovid since Friday; blood sugar has been over 400; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Covid-19" (unspecified if ongoing), notes: She was one of the first people in (Withheld) to get Covid when it first started; "coma for 3.5 weeks" (unspecified if ongoing) notes: she was hospitalized on a ventilator and in a coma for 3.5 weeks. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant), outcome "unknown" and all described as "Female consumer states she has Covid and has been taking Paxlovid since Friday"; BLOOD GLUCOSE INCREASED (non-serious), outcome "unknown", described as "blood sugar has been over 400". The patient underwent the following laboratory tests and procedures: Blood glucose: over 400, notes: all weekend; currently 401; SARS-CoV-2 test: Positive, notes: she has Covid and has been taking Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: Female consumer states she has Covid and has been taking Paxlovid since Friday. She has 1 and a half days left. She has been taking it while also taking Metoprolol and Carbamazepine. She states that she does not think there are any interaction between Paxlovid and Metoprolol but that she now sees where is says on the paperwork not to take Paxlovid if you take Carbamazepine. She would like more information on this.  She also states that she has taken 4 Pfizer Covid vaccines. She was one of the first people in (Withheld) to get Covid when it first started and she was hospitalized on a ventilator and in a coma for 3.5 weeks. She states that she doesn't want the Covid to get that bad again. She has not had many problems since. States that her blood sugar has been over 400 all weekend and it is currently 401. States that she read that Covid 19 can cause diabetes by attaching the pancreas in 30-40% of adults.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
On Sunday, July 9, 2017, at 0955 hours; patient informed me he was experiencing the following; pharyngitis, arthralgia, fatigue, anorexia, dysphagia and felt as if he was febrile. He stated he believed it to be a reaction to the Hepatitis B Vaccine he received on July 5, 2017.  At 1505 hours, patient informed me he was having a friend take him to the hospital due to be unable to swallow at all. At 1820 hours; patient informed me he had been discharged from the hospital with a diagnosis of strep throat and hematuria.  He had been given an antibiotic and was told to remain off work for at least twenty-four (24) hours.
Patient was 6 years old.  Inadvertently received the 6m-4y Pfizer Covid-19 vaccine.  No current symptoms as vaccine was given today 7/25/2022.
Developed fever of 102.4. Tylenol taken for fever. Fever remained at 102 until approx 10:00 am 10/18/2013. Fever then reduced to 100-101 for the next 10 hours. The above was reported to the employee health nurse at hospital (who administered the injection) and she advised writer to take Tylenol for the fever.
34-year-old female psychologist received a flu shot on 10/12/2020. She reports that the following day she started to develop redness, swelling, and pain in the Left Shoulder. She also reported a fever but did not take her temperature. Her symptoms continue to worsen through 10/15/2020 despite use of antihistamines.  She ultimately presented to the ED. She was treated with Keflex 500mg Q 6hrs for cellulitis which improved her symptoms.  She reports a significant amount of Allergies as well totaling 21 foods as well as plants and seasonal allergies. She has since completed the antibiotics and is presently reporting resolution of her symptoms. She reports an occasional itch in the area in questions but on presentation denies any further pain, redness swelling or aggravating factors.  She denies any allergies to medications and uses spironolactone for acne, she also uses Zyrtec and Allegra.
flu; COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID) and INFLUENZA (flu) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.  On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jan-2022, the patient experienced COVID-19 (COVID). On an unknown date, the patient experienced INFLUENZA (flu). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID) and INFLUENZA (flu) outcome was unknown.  No medical history information was reported.  Concomitantly, the patient was also taking unknown heart medication.  Reportedly, the patient did not have the administration dates and the lot number of Moderna shots because she did not have the vaccination card with her.  The patient received Tylenol as corrective treatment for the event COVID. Treatment information for the event flu was not reported by the reporter.  Company comment:  This case concerns a 55-year-old female patient with no reported medical history who experienced non-serious unexpected AESI of COVID-19, that occurred approximately after the 2nd dose of the mRNA-1273 however, the exact time to onset was not provided .  No further details were provided. Lack of efficacy not captured due to unspecified time between doses. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 55-year-old female patient with no reported medical history who experienced non-serious unexpected AESI of COVID-19, that occurred approximately after the 2nd dose of the mRNA-1273 however, the exact time to onset was not provided .  No further details were provided. Lack of efficacy not captured due to unspecified time between doses. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Administered Tdap to a 77 year old male client is above recommended age for vaccination. Client was called with in 24 hours after incident. Client reported no adverse reaction to vaccine, except soreness at injection site.  Patient did not have adverse event.  TDAP mis-administered 77 yr old client.
Patient received first dose of COVID vaccine with the Pfizer product on 7/21/2021, then later received the Moderna product as the second dose in the series on 8/12/2021. No adverse events were reported following these administrations.
fatigue; glands swollen on left side; This is a solicited report based on the information received by Pfizer from regulatory authority. (MFR Control No. # 21K-163-3987976-00).  A contactable consumer (patient) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 2021 (batch/lot number was not reported) as dose 2, single for COVID-19 vaccination; adalimumab (HUMIRA), subcutaneous from an unspecified date (batch/lot number was not reported) and ongoing, at an unspecified dose (citrate free) for psoriatic arthritis. Medical history included patient was ill with breast cancer in 2017, she had cold in 2018 (cold resolved), and she had osteoporosis. The patient's concomitant medications were not reported. The patient previously received BNT162B2, intramuscular in Apr2021 as dose 1, single for COVID-19 immunization and experienced fatigue. In 2021, she received 2nd dose of COVID-19 vaccine manufactured by Pfizer. After second shot, she had fatigue and two days later she had glands swollen on left side. Events were reported as other medically important conditions. The action taken in response to the events for adalimumab was dose not changed. The outcome of the events was unknown. The reporter's causality for the events of breast cancer, osteoporosis, fatigue onset in Apr2021, fatigue onset in 2021, glands swollen on left side and cold with adalimumab was no reasonable possibility. The reporter's causality for the events fatigue and glands swollen with BNT162B2 was probable.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the available information in the case, the causal association between the events fatigue, lymphadenopathy and the suspect drug BNT162B2 cannot be excluded.
A brain leak; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROSPINAL FLUID LEAKAGE (A brain leak) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic and Hypertension.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CEREBROSPINAL FLUID LEAKAGE (A brain leak) (seriousness criterion medically significant). At the time of the report, CEREBROSPINAL FLUID LEAKAGE (A brain leak) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided.  Patient  was schedule for surgery and wanted to know the waiting period she had to wait before having surgery or taking the second dose No treatment information mentioned.  This case concerning a 68-year-old female patient with relevant medical history of Diabetes mellitus and Hypertension, who experienced the serious unexpected event of Cerebrospinal fluid leakage. The event occurred on unknown date after the first dose of mRNA-1273 vaccine administration. The event was conservatively considered as related to the product administration; however, the temporal association cannot be determined due to the limited information. The rechallenge was not applicable since no information available on the second dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerning a 68-year-old female patient with relevant medical history of Diabetes mellitus and Hypertension, who experienced the serious unexpected event of Cerebrospinal fluid leakage. The event occurred on unknown date after the first dose of mRNA-1273 vaccine administration. The event was conservatively considered as related to the product administration; however, the temporal association cannot be determined due to the limited information. The rechallenge was not applicable since no information available on the second dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
red and warm at day 10 in same arm as vaccine was administered in. Required oral antibiotics for infection.; red and warm at day 10 in same arm as vaccine was administered in. Required oral antibiotics for infection.; red and warm at day 10 in same arm as vaccine was administered in. Required oral antibiotics for infection.; Enlarged axillary lymph node/Became red and warm at day 10 in same arm; This is a spontaneous report from a contactable nurse (patient herself).  A 28-year-old female patient (not pregnant) received her first dose of bnt162b2 (BNT162B2 also reported as Covid-19 vaccine, lot EH9889), via an unspecified route of administration in the left arm on 28Dec2020 11:45 at SINGLE DOSE for Covid-19 immunisation. She received the vaccine in a hospital. Medical history included allergy to latex and COVID prior vaccination: No. No other vaccine in four weeks. Concomitant medication included unspecified oral contraceptive. The patient experienced enlarged axillary lymph node that appeared 8 days after vaccine administration (05Jan2021). It became red and warm at day 10 (07Jan2021) in same arm as vaccine was administered in. Required Keflex 500 mg oral antibiotics for infection. No Covid tested post vaccination. The outcome of events was recovering.
UNDERDOSE; This spontaneous report received from a parent concerned a 19 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested . No concomitant medications were reported. On 03-MAY-2021, the subject experienced underdose. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The outcome of underdose was not reported. This report was non-serious.
On 9/17/2022, basically I started coughing, a hard cough. I did not feel sick. I did not feel like I had a cold, just basically coughed a lot. I did not feel bad, but I was going to a party, and I wanted to be safe. I tested on 9/18/2022 and it was positive. I was getting tired easily. I did not feel horrible. I had a cough that I could not shake. On 9/19/2022 I called my doctor and she prescribe PAXLOVID. By 9/23/2022 I was feeling pretty good.
1/2inch diameter red area @ inj site;area firm no pain, swelling or warmth;5NOV96 pt states area is smaller, firm dark red & itching;
headaches; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "not recovered", described as "headaches".  Additional information: A patient called in and said since he get the Pfizer covid-19 vaccine booster shot 10 months ago he was still having headaches (at the time of report). Caller said he talked to 200 people who have a headaches from that booster shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a nurse regarding unspecified number of patients of unknown age. Concurrent conditions and medical history were not reported. On an unknown dates, the unspecified number of patients were vaccinated with ROTATEQ (dosage regimen, lot # and expiry date were not reported) that was stored improperly (inappropriate product storage). No adverse events were reported. No further information was provided. This case is one of the several reports from same reporter. Additional information has been requested.
Case PHEH2016US026381 is an initial spontaneous report received from a consumer on 10 Oct 2016. This report refers to unknown demographics patient. Medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number and expiry date not reported) at a dose of 0.5 ml intramuscular on Oct 2015. On an unknown date, it was reported that, the patient experienced shoulder pain; tongue swelled up and went to emergency room for 8 to 10 hour. The patient was treated with BENADRYL and patient recovered before release from emergency room. The outcome of the events was reported as complete recovery. The seriousness of the events was not reported. The causality of the events was not reported.
Covid monitoring documentation. PT admitted 1/7/22 documented to have positive covid. PT received Janssen  5/9/21 Lot 201A21A for dose 1.
11NOV93 began wheezing & coughing w/fever seen by MD; 12NOV93 worsening wheeze & fever; 13NOV93 hospitalized for wheezing, chest retractions & fever 100.8; 15NOV93 rehospitalized for 02 sat 80%; MD suspected croup;