chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a healthcare professional and described the occurrence of arms redness in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline), PNEUMOVAX. On an unspecified date the subject received a dose of FLULAVAL (unknown route, left arm) and unspecified dose of PNEUMOVAX (unknown route, left arm). It was not clear whether the vaccinations were mixed together or whether they were just administered in the same arm. At an unspecified time after vaccination with FLULAVAL and PNEUMOVAX, the subject experienced "redness in arm", injection site pain and fever. At the time of reporting the outcome of the events was unspecified.
Felt mildly fluish by end of working shift (1130 pm), arm became more sore, unable to lay on it in bed. Woke up in middle of night with body aches , chills and headache. By 10 am felt increase in flu like symptoms, mild nausea, swollen glands, mouth cold sore and red hot face. Temp was 101.2. All joints hurt, general malaise.
pt recvd vax;  pt devel fever w/ t 101, vomiting, nausea & diarrhea;
This spontaneous report as received from a physician's assistant refers to a patient of unknown age and gender. On 02-SEP-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # L003855 exp date 05-FEB-2017) (dose and route not reported). The temperature excursion was 53.8 F for 10.75 hours from 17-AUG-2015 to 06-NOV-2015. No adverse event was reported. This is one of several reports received from the same source. Additional information is not expected as all follow up information to complete the case was received.
PATIENT WAS GIVEN THE SECOND DOSE OF MODERNA VACCINE AT 20 DAYS INSTEAD OF 28 DAYS. WHEN PATIENT CAME TO THE PHARMACY FOR HER VACCINE, PATIENT WAS ASKED IF SHE WAS GETTING A FIRST OR SECOND DOSE AND PATIENT STATED THEY WERE GETTING A FIRST DOSE. AFTER PATIENT WAS ADMINISTERED THE VACCINE, PATIENT STATED THAT SHE WAS ACTUALLY GETTING HER SECOND DOSE AND IT WAS DISCOVERED THAT HER FIRST DOSE WAS GIVEN ONLY 20 DAYS PRIOR. NO ADVERSE EFFECTS WERE NOTED AFTER VACCINATION.
Still have Pain in upper arm where vaccine was given now more than 4 months later.  Difficult to sleep on my left side.  Hurts.  PCP did ultrasound and asked a lot of questions. PCP did an ultra sound at about 2 months to be sure there were no blood clots. There were not. PCP wants to see me again next week specifically to address pain in arm at site of injection. PCP is considering putting me on prednisone to see if that helps.  NOTE  this is unresolved so difficult to answer question 21  hopefully this is not disability or permanent damage.
Casey was given DPT/MMR/OPV while still on anitbiotic Pedizole and tassii organdin for otitis & bronchitis. He appeared happy & well until he died in his sleep. Shots were given on 5DEC89.
No adverse event; The patient was "inadvertently administered an adult dose of VAQTA instead of a pediatric dose today"; This spontaneous report was received from a physician assistant concerning a 16-year-old patient of unknown gender.    The patient's concurrent conditions, medical history and concomitant medications were not provided.   On 08-AUG-2019, the patient was inadvertently vaccinated with an adult dose of hepatitis a vaccine, inactivated (VAQTA) (lot # S007265; Expiration date: 07-JUL-2020) instead of pediatric dose (indication and dose were not provided).    No adverse events were reported.
Patient reported to her husband (MD) that she was having difficulty swallowing and her throat was scratchy and swelling closed. Her husband left night duty and came home. Gave pt Benadryl. Pt reported to MD where it was determined she had suffered an allergic reaction to the vaccination. Pt reported to pharmacy today to let us know of reaction and reported feeling better but still not feeling well.
Per NP note, "...presented to vaccine cancer center to receive first dose of COVID 19 vaccination. First dose of Pfizer vaccine (Lot # EN6202) administered. Immediately after administration, Pt complained of acute mid-sternal chest pain described pressure. EKG completed, Pt observed for an additional 20 minutes, reported spontaneous resolution of symptoms. Prior to discharge pain completely resolved, lungs clear to auscultation , cardiac exam with normal S1 & S2,no rubs, gallops or murmurs. Pt admitted to being anxious, has a documented history of white coat syndrome."
Pyrexia/ Slight Fever; Medicaiton error/Inappropriate dose of drug administered; Influenza like illness (flu-like symptoms). Follow up information received form the healthcare provider, on 15-Mar-2003, provided additional demographics, vaccination details, including date and lot number, additional details of adverse event, including date, and recovery status, and reported previous history, allergies and birth defects as none. Information regarding Flumist (2003-2004 formula) nasal solution (frozen)) was received from a nurse regarding a 23 year old female patient who received a partial dose on 21-Jan-2004 developed a mild fever and flu like symptoms. A nurse reported that a 23 year old female patient refused the second half of a divided dose of flumist (medication error) on 21-Jan-2004. On 24-Jan-2004, she developed a mild fever/ pyrexia and flulike symptoms (influenza like illness) which were described as stuffy nose, aches and tiredness. The reporter indicated that the patient received "over the counter treatment for mild fever and aches." The reporter also indicated, that the patient's signs and symptoms lasted 4 days and she recovered.
Information has been received from a nurse practitioner concerning a 30 year old female who on 03-Jul-2003 was vaccinated with a dose of MMR vaccine live (second generation) (lot #642968/0530M). Concomitant therapy included cetirizine hydrochloride (Zyrtec) being taken PRN for an unknown indication. On 16-Jul-2003 the patient developed a widely disseminated, itchy, burning, red, but not raised rash and nausea. The patient sought unspecified medical attention. Additional information has been requested.
asthma Narrative:  asthma, copd, bronchiectasis exacerbation - meds: albuterol, advair, spiriva, qvar
product storage error temperature too low with no reported adverse event; administered to patient post excursion with no adverse event; Initial information received on 16-Feb-2023 regarding an unsolicited non-valid non-serious case received from other health professional.  This case is linked to cases 2023SA057733(CLUSTER), 2023SA054981(CLUSTER), 2023SA057309(CLUSTER) and 2023SA068949(CLUSTER).  This case involves adult patient of unknown gender to whom influenza quadrival A-B vaccine [Fluzone Quadrivalent] was administered post excursion with no adverse event and reported product storage error temperature too low with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date there was product storage error temperature too low with no reported adverse event (product storage error) for influenza quadrival A-B vaccine.  On an unknown date, the patient received suspect influenza quadrival A-B vaccine suspension for injection at an unknown dose (lot number: UT7683NA, UT7682JA, expiry date: 30-Jun-2023) via unknown route in unknown administration site for prophylactic vaccination (immunisation).  On an unknown date administered influenza quadrival A-B vaccine to patient post excursion with no adverse event (poor quality product administered) (same day latency) following the administration of influenza quadrival A-B vaccine.  Action taken: Not applicable.  Outcome: Unknown for both the events.   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.
At about 6am on 04/01/2002, patient developed erythematous macules which progressed to edematous papules over trunk and scalp. A few (less than 5) lesions had developed central vesicles at time of office visit about 2pm on 04/01/2002. Mom reported rash was preceded by a temperature of 101 on 3/30/02.
From an initial report received on 12/28/2000, it was reported that a 20 year old female was vaccinated in the left arm with Menomune on 04/26/2000 at 1:30pm. five to seven mins later, the pt reportedly experienced "lightheadness"..."while sitting." The pt reportedly recovered from this experience.
Severe Muscle aches in back and neck lasted for 9 days Muscle twitch in legs came on after 10 days and ongoing
COVID 19 Treatment/ positive PCR on the 25th; COVID 19 Treatment/ positive PCR on the 25th; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 50-year-old male patient received BNT162b2 (BNT162B2), on 15Mar2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 49 years 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: "Follicular lymphoma" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Levothyroxine, start date: 01Mar2015. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25May2022, outcome "unknown" and all described as "COVID 19 Treatment/ positive PCR on the 25th". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24May2022) Negative, notes: had a negative antigen test on the 24th,; (25May2022) Positive, notes: but positive PCR on the 25th. Therapeutic measures were taken as a result of covid-19 which include Paxlovid via Oral route from early hours of 26May2022 to 30May2022.   Clinical course: The patient did not have COVID prior to this. He began to feel unwell overnight on 23May2022. His symptoms were initially a sore throat (brief), fevers, significant body aches, fatigue, and SOB.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information currently available,The casual association between the reported events and suspected vaccine BNT162B2 cannot be completely excluded.
Sick at stomach, vomiting, diarrhea, chill, fever, hearing loss, fainting.
1st dose 2018, 2nd 23 feb2023; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 34-year-old male patient who received HAV (Havrix 1440 adult) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Havrix 1440 (received a 1st dose of Havrix back in 2018 when patient was 29 years old).   On 23rd February 2023, the patient received the 2nd dose of Havrix 1440 adult and Havrix Pre-Filled Syringe Device. On 23rd February 2023, unknown after receiving Havrix 1440 adult and Havrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 24-FEB-2023 Reporter's Comment: The reporter called to inquire how to proceed with Havrix series Or would patient be considered complete. The reporter reported a patient.  The patient received a second dose of Havrix the day before reporting. The reporter mentioned that the reason they administered the second dose was due to the patient's lab work done on 9th August 2023 showed non-reactive. The reporter was unable to provide vaccine details of Lot and Expiration. The reporter did not consent to follow-up. Additional Supportive Information: The patient received 2nd dose of Havrix later than the recommended schedule, which led to lengthening of vaccination schedule.
broke her ankle; blacked out and passed out; trouble breathing; didn't feel good; nauseated; felt light headed; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (blacked out and passed out) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided.  Concomitant products included PREDNISOLONE, TIMOLOL, LABETALOL and LOSARTAN for an unknown indication.   On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced DIZZINESS (felt light headed), MALAISE (didn't feel good) and NAUSEA (nauseated). On 09-Apr-2021, the patient experienced DYSPNOEA (trouble breathing). On 11-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (blacked out and passed out) (seriousness criterion medically significant) and JOINT INJURY (broke her ankle). At the time of the report, LOSS OF CONSCIOUSNESS (blacked out and passed out), DIZZINESS (felt light headed), JOINT INJURY (broke her ankle), DYSPNOEA (trouble breathing), MALAISE (didn't feel good) and NAUSEA (nauseated) outcome was unknown.            Treatment medications were not provided.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Received immunizations 5/24/06. That evening had fever 101.4 (R). This AM 5/25/06 temp 103.5 (R). Mom gave Tylenol. Not wanting to eat or take formula this AM. He did take Pedialyte. Temp 100 (R) at 10:45 AM in office.
Red circular rash at the injection site appeared 2 weeks post injection. There were no adverse reactions such as fever or sickness. The area was raised and hot , but it did not itch.
Went in so slow, no pulling back on plunger Fever, vomiting, passed out, called 911, was out of work for 1 week, bled excessively.  Spoke to doctor about it, give benadryl prior to immunization.
7cm diameter local reaction rt arm; tx ice, elevation rt arm, APAP or Ibuprofen for pain; warm compresses p/24 hrs;
Rash, fever.  Tx: Benadryl, Aveeno bath.
tested positive; tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old male patient received BNT162b2 (BNT162B2), on 06Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 31 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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 was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovering" and all described as "tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09May2022) Positive; (03May2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
The patient was complaining of increased heart rate. I took the patient blood pressure and heart rate and they were BP:140/80 HR:80.
2 days later (May 7) developed eczema, and went to Emergency Room twice for the worsening rash. (May 9 and May 10).; told it was only eczema and discharged home. 7 days after vaccination (May 12) she is hospitalized  with anaphylactic reaction and in the ICU for 5 days. No other exposures prior to this event other than the vaccine to explain the anaphylaxis. She continues to have episodic pruritis, despite  anti-histamines.
Rash started pt on 7/2/06 started Amox on 7/3 finished meds cleared up rash. New rash started a 7/10/06 1st rash flat patchy red. 2nd rash bumpier not itchy.
after 8days i think?there is a lymphatic mass ?2cm?in my left axilla?still not go away ...
syncopal episode after injection.  Patient unconscious for approximately 5 minutes,  transferred from chair to gurney to EMT triage area.  5:20 pm - BP 129/78, p-64, O2 sat- 94%, given water,  and monitored. Denies chest pain, Shortness of breath, dyspnea , no dizziness.   Sitting- 5:30 pm - BP 128/76, p-69, O2 sat- 94% Able to stand without difficulty.   5:35 pm -  patient discharged with husband, able to stand without difficulty. When she returns for second dose, she will let the staff know and she will receive her vaccine in the triage room while lying down on gurney.
pt recv vax 3NOV98 & 4NOV98 lab eval revealed pt had elevated SGOT (60) & elevated SGPT 360;pt sought unspecified medical attention;pt eat 4 to 5 carrots a day & learned that carrots could affect the liver;
3 incidents in clinic where 3 minors were given Moderna Covid-19 vaccine booster doses (0.25mL).; They each received doses 1 & 2 of Pfizer Covid-19 vaccine prior to receipt of Moderna booster; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (3 incidents in clinic where 3 minors were given Moderna Covid-19 vaccine booster doses (0.25mL).) and INTERCHANGE OF VACCINE PRODUCTS (They each received doses 1 & 2 of Pfizer Covid-19 vaccine prior to receipt of Moderna booster) in a 16-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (2nd dose) and PFIZER BIONTECH COVID-19 VACCINE (1st dose). Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 28-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (3 incidents in clinic where 3 minors were given Moderna Covid-19 vaccine booster doses (0.25mL).) and INTERCHANGE OF VACCINE PRODUCTS (They each received doses 1 & 2 of Pfizer Covid-19 vaccine prior to receipt of Moderna booster). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (3 incidents in clinic where 3 minors were given Moderna Covid-19 vaccine booster doses (0.25mL).) and INTERCHANGE OF VACCINE PRODUCTS (They each received doses 1 & 2 of Pfizer Covid-19 vaccine prior to receipt of Moderna booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment medication reported.
Information has been received from a pharmacist concerning an elderly female who was vaccinated with a dose of Zostavax (Oka/Merck).  It was reported that the patient developed 2 bouts of shingles.  Unspecified medical attention was sought.  A product quality complaint was not involved.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 3/26/2008. Additional information has been received which indicated that neither the patient nor the doctor wish to follow up. No further information is expected.
Upper extremity swelling, erythema, and tenderness gradually worsening/spreading over 2 days. Fever to 101F. Treated with Tylenol and Motrin. Also initially given IV Clindamycin x 1 for concern for cellulitis.
Patient received 0.2mL of undiluted vaccine.  The vaccine was not diluted prior to administration.
Urine test positive for methadone; This spontaneous case was reported by a consumer and describes the occurrence of URINE ANALYSIS ABNORMAL (Urine test positive for methadone) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Arthritis and Hypokalemia. Concomitant products included TRAMADOL, MELOXICAM, HYDROCHLOROTHIAZIDE, POTASSIUM CHLORIDE (KLOR-CON M10) and AMLODIPINE for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced URINE ANALYSIS ABNORMAL (Urine test positive for methadone). At the time of the report, URINE ANALYSIS ABNORMAL (Urine test positive for methadone) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Mar-2021, Drug screen: positive for methadone (Positive) positive for methadone..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
The worst thing is the coughing and I have been using cough medicine. I have been really tired, that is not me. I have a call in to get the antibodies infusion.
Pt developed cellulitis on the site of Pneumococcal vaccine with fever, vomiting 01/9/09.  11 1/2 hours after the shot treated with Abx augmentin.
When injecting the vaccine the syringe/needle failed and vaccine started dripping down the patient's arm.  She was offered another vaccine in the opposite arm and it was administered immediately.
Red, hot itch at site of injection. Apply Benadryl and oral Ibuprofen.
When went to see the doctor and told her about it, the doctor, who is thin like said got the Moderna Covid vaccine and also was having heart palpitations; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (When went to see the doctor and told her about it, the doctor, who is thin like said got the Moderna Covid vaccine and also was having heart palpitations) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (When went to see the doctor and told her about it, the doctor, who is thin like said got the Moderna Covid vaccine and also was having heart palpitations). At the time of the report, PALPITATIONS (When went to see the doctor and told her about it, the doctor, who is thin like said got the Moderna Covid vaccine and also was having heart palpitations) outcome was unknown. Not Provided      The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       No concomitant medication was reported.  When reporter went to see the doctor and told her about it, the doctor, who was thin like said got the Moderna Covid vaccine and also was having heart palpitations.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-740764 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-740764:same reporter
Ringing in ears, very loud for the first two weeks after, subsided a lot after 3 weeks but is still present at 5.5 weeks after