chrisvoncsefalvay/vaers-outcomes huggingface dataset:
was given fluzone high dose quadrivalent instead of fluzone quadrivalent with no reported adverse event; less than 65 years of age who was given fluzone high dose quadrivalent with no reported adverse event; Initial information received on 06-Oct-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2023SA310779.  This case involves a 59-years-old male patient who was given influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent] instead of influenza quadrival A-B vaccine [Fluzone Quadrivalent] at less than 65 years of age with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the 59-years-old patient received unknown dose of suspect influenza quadrival A-B high dose HV vaccine (unknown formulation) (batch number: U8135BA; expiry date unknown) via unknown route in unknown administration site for immunization instead of suspect influenza quadrival A-B vaccine, suspension for injection (batch number, expiry date unknown) with no reported adverse event (wrong product administered) (product administered to patient of inappropriate age).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for 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.
No additional adverse experiences were reported as a result of the vaccine administration; the product was improperly stored and administered; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 26-JUL-2021 at 08:00, the patient was vaccinated with an improperly stored single dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (rHA) lot # T021643, expiration date 21-DEC-2021 (route of administration and anatomical location were not reported) for prophylaxis (product storage error). No additional adverse experiences were reported as a result of the vaccine administration. Administered dose of vaccine experienced the temperature excursion of 5 degrees Celsius for 92 hours. Data logger was not involved. There were no previous excursions reported.  This is one of several reports received from the same reporter.
Within 15 minutes of receiving injection, felt chest tightness.  (Did not return to clinic.)  Lasted a few minutes.  In evening felt feverish, aching & had chills until fever broke in the night.  R underarm lymph nodes swollen & tender, lasted 48-60 hours.  No treatment sought.
Arm went stiff for two or three days and it was very painful and ache , bruise at injection site  for weeks no rash.
This spontaneous report as received from a nurse refers to a 21 months 15 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) LIQUID PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
This initial spontaneous case, received on 27-Oct-2017 was reported by other health professional and concerns a patient of unspecified age and gender. On 25-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose:0.5ml, route of administration: intramuscular, anatomical location: right deltoid, batch number:00844621A, expiry date: 30-Jun-2018). On 25-Oct-2017, while injecting vaccine the hub of the needle separated from the syringe and the patient received roughly half a dose. It was confirmed that there were no problems or defects with the product. It was reported that, the patient had no experienced any adverse events. Reporter stated that, the patient is doing good. The reporter assessed this case as non-serious.
Rec'd immunizations 2/4/05 next day had fever,warmth, redness, swelling left deltoid region. Fever resolved but erythema/induration persisted. Seen in office 2/8/05 for Benadryl prescribed.
Employee was given varivax vaccine on 2/19/08. She states that 2 days ago she developed a "mosquito bite" like area at site of injection. States the site is itchy and tender but has decreased in size since she first noticed it. Covered with bandaid and told to take tylenol or advil prn.
Information was received on 13-MAR-2017 from a registered nurse regarding a female patient (age not provided). Medical history, concurrent conditions and concomitant medications were not reported. On 13-MAR-2017 the nurse reported the patient was administered a dose of ROTATEQ (lot number and dose not provided) which was improperly stored. No adverse effects were reported. Temperature 46-77 degrees Fahrenheit for 2.5 hours. There was no previous temperature excursion. Call was made because of a "data logger". Outcome was reported as "supported". No further information was provided. Additional information has been requested.
Dry mouth; Body aches; Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DRY MOUTH (Dry mouth), MYALGIA (Body aches), PYREXIA (Fever) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DRY MOUTH (Dry mouth), MYALGIA (Body aches), PYREXIA (Fever) and HEADACHE (Headache). At the time of the report, DRY MOUTH (Dry mouth), MYALGIA (Body aches), PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown.            Concomitant medications were not provided. Treatment information was not reported.
Inadvertently 2 doses of Moderna COVID-19 vaccines administered to patient at age 17.  Dates of vaccines are: first dose 06/30/2021 see above details.  Second dose administered on 08/28/2021 intramuscular 0.5 ml left deltoid Lot number 037C21A. Patient did not report any adverse reaction after administration of vaccines
Patient received one dose of SHINGRIX on 4/9/18 and represented to provider's office on 4/10/18 with symptoms of pain to area and the reaction site was warm to touch.
Developed itchy rash that got progressively worse and and was finally diagnosed as Shingles by doctor on 5-4-21 as pain got so bad and it was not getting better. Also had fever blister outbreak which did subside.
4-APR-89 came in for TD Booster. Last booster had been given 1-MAR-79.  Returned to office 6-APR-89, complaining of pain, redness and swwelling at site of injection.  Also had fever up to 103.  Physician noted on chart modify next dose.
Patient was given a dose 1 day after the BUD. No adverse effects reported. Valid dose and no need to revaccinate per clinical studies
My daughter gets a lot of bloodwork all of the time for her pre-existing conditions. She was feeling weak, bruising and a high heart rate so we had expected something was going on, but we didn't think too much into it and decided to wait until her doctor appointment. At her doctor appointment they did blood work which showed that her blood lines had crashed. She was prescribed steroids', infusion as well as an immunosuppressant.
I started with a sore throat, fatigue, headache. I also had upset stomach and diarrhea. I tested myself 3 times before finally testing positive on September 02, 2022. 5 or 6 days into it, I went to an urgent care clinic on September 07, 2022. I had developed and ear and sinus infection and was given Doxycycline. I took acetaminophen for my headache. It took me up until September 10 to start to feel better, but I was still having some ear and sinus issues. By September 14 I had completely recovered from all symptoms.
flu like symptoms; right arm pit (hard and itching) swollen; right arm pit (hard and itching) swollen; fever; swollen lymph; chills; This is a spontaneous report from a contactable healthcare professional (patient). A female patient of an unspecified age (reported as 45, unit unknown) received the first dose ofBNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had question about getting 2nd vaccination/dose. At end of Oct2020/beginning of Nov2020, she was positive for COVID. After a month and 1/2 after COVID19, she got the vaccine. After first vaccination, 18 hours later patient had the flu like symptoms and right arm pit (hard and itching) swollen. She had fever, swollen lymph nodes at 10 or 11 O'clock. Patient had chills, fever, flu like symptoms. 18 days after, the lump was there. Outcome of the events was unknown. Patient was asking if it was okay to get the 2nd shot.  Information of lot/batch number has been requested.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 59-year-old male patient received BNT162b2 (BNT162B2), on 28Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 59 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ADVIL [IBUPROFEN]; ROBITUSSIN [DEXTROMETHORPHAN HYDROBROMIDE]; TYLENOL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: COVID-19 Treatment; positive, notes: rapid test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received Paxlovid, orally from 26Jul2022 to 31Jul2022 for COVID-19 treatment. The patient had no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The reported COVID-19 positive after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Hives covering arms, legs, and half of face. These continue to erupt periodically throughout the day. (This is now the 6th day). The hives temporarily go aww3ay for a few hours after taking BENADRYL.
Day of vaccine administration 11/5. Pt started with noted swelling and itching at site. Improved by 11/9 when pt came for evaluation. Pt found to have 2cm indurated area with mild tenderness/swelling erythema. Given XYZAL, one daily for 3 days, ice prn.
Vial expired on 08-Jul-2022, stored in refrigerator on 13-Jul-2022 and administered on 13-Jul-2022.; Booster dose administered after date of expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Booster dose administered after date of expiry) and PRODUCT STORAGE ERROR (Vial expired on 08-Jul-2022, stored in refrigerator on 13-Jul-2022 and administered on 13-Jul-2022.) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048L21A and 077C21B) for COVID-19 vaccination.     Patient did not received any other vaccine within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Allergic reaction to antibiotics (Allergic to Amoxicillin).   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Booster dose administered after date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial expired on 08-Jul-2022, stored in refrigerator on 13-Jul-2022 and administered on 13-Jul-2022.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Booster dose administered after date of expiry) and PRODUCT STORAGE ERROR (Vial expired on 08-Jul-2022, stored in refrigerator on 13-Jul-2022 and administered on 13-Jul-2022.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. The Number of doses per vial were 2 doses from 1 vial. The patient had received First booster dose of Moderna vaccine on 11-Nov-2021. The patient had received second booster dose of Moderna vaccine on 13-Jul-2022. Frozen vial used had an expiry date of 8-Jul-2022 The vial was initially stored in the refrigerator on 13-Jul-2022. The vial did not undergo any temperature excursions. No treatment medication was provided by the reporter.   This case was linked to MOD-2022-608757 (Patient Link).
Chills "shaking like a leaf", feeling of unwell. Started in the early morning around 1:30am. Feels very tired. No fever. Chills are now gone.
Information has been received from a pharmacist concerning a 45 year old Caucasian female, who on approx. 1/25/01 was vaccinated with Hep-B and "shortly thereafter", the pt experienced "anaphylactic reaction. Client had itchy rash, shortness of breath, and her throat was closing." On 1/25/01, the pt went to the ER and was treated and released. On 1/26/01, the pt again experienced "anaphylaxis" and went to the hospital and was admitted for 3 days. Anaphylactic reaction and anaphylaxis were considered to be immediately life-threatening. Additional information has been requested. F/U on 1/29/01 the pt was discharged from the hosp with a dx of anaphylactic reaction of unknown etiology, probably secondary delayed reaction to hepatitis B vaccine. The nsg reported that the pt has not had anymore anaphylactic reactions. Anaphylactic reaction and anaphylaxis were considered to be immediately life threatening. Additional info has been requested.  Follow up on 06/29/2001: "Lot # for vaccine 1 is not provided."
received an expired dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number E2L54, expiry date 03-MAR-2023) for prophylaxis.   On 07-MAR-2023, the patient received Kinrix. On 07-MAR-2023, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: received an expired dose).The outcome of the expired vaccine used 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- 08-MAR-2023. A nurse reported that a patient received an expired dose of Kinrix on 7-MAR-2023. The vaccine expired on 3-MAR-2023.  The reporter was consented to follow up via email. The patient received vaccine beyond the expiry date which led to expired vaccine used.
Patient were administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021; Patient were administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient were administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient were administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021 at 1:44 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 12-Feb-2021 at 1:44 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient were administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient were administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient were administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient were administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 71.15   Concomitant products were not provided.  On 12-Feb-2021 vials were moved to clinic. On 09-Feb-2021 the vaccines were moved to fridge. On 12-Feb-2021, the vial underwent the excursion on the following timings: at 09 AM temperature was 29, at 10 AM temperature was 35 and at 11 AM temperature was 35.  The vaccine beyond use date was reported as 10-Mar-2021. Condition of vaccine prior to administration was not frozen.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  It was reported that, the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The health care professional explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree Fahrenheit.  Treatment medications were not reported.
pt became flushed in face & neck & began c/o throat closing up;placed on deck given epi & DPH, 02 via mask;taken to trauma room for further eval;no hives;
Large (roughly 18 cm X 8 xm, oval shaped,) progressive welt or hive with associated pain and redness. Right maxillary sinus pain, swelling, redness, and tenderness. Low grade fever, lethargy, somnolence, and paresthesia of the face, neck, and shoulder, and dizziness.
tested positive for covid 11/22/21, asymptomatic- tested as part of follow up due to known exposure
Booster dose given to patient before the age of 16 in error.  Family has been informed, patient has experienced no adverse symptoms.  Fathers name and phone number listed above.
The pt developed dizziness, lightheadedness, headaches and a large welt (2 1/2 inches) at the injection site.
Pt went to the er due to having an temperature of 104.  She was tested for covid and sepsis. Both were negative. Er doctor believed that the fever was due to the vaccines. Pt is taking tylenol every 4 hours or else the fever goes up.
difficult to walk; left leg pain; pain going from her right shoulder and going down to her back; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (difficult to walk), PAIN IN EXTREMITY (left leg pain) and ARTHRALGIA (pain going from her right shoulder and going down to her back) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced GAIT DISTURBANCE (difficult to walk), PAIN IN EXTREMITY (left leg pain) and ARTHRALGIA (pain going from her right shoulder and going down to her back). At the time of the report, GAIT DISTURBANCE (difficult to walk), PAIN IN EXTREMITY (left leg pain) and ARTHRALGIA (pain going from her right shoulder and going down to her back) outcome was unknown.            Patient's concomitant medications included unspecified medicines for high blood pressure.  Patient did not use any treatment medicines for the symptoms.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Follow up report included no new information
I felt fine until 1:30 in the morning.  I woke up with a low fever, 99.5, very achy all over (especially the shot arm, my neck and lower back) then noticed a big lump under my left armpit.  It is soft and squishy, not hard like a tumor.  The fever and aches only lasted one day with Tylenol.  The lump is still present.
Pt stated that arm became swollen, red, hot, itchy and tender from appoximately 2-3inches below injection site to the elbow.  Pt used cold compresses and Tylenol without relief. Pt went to his PMD who ordered Levaquin 500mg po x 7 days.
I had an episode of confusion while attempting to speak to my daughter on the phone, approximately 24 hours after my 2nd vaccine shot.  I was speaking but not making sense. I recognized that I was speaking but did not understand what I was attempting to communicate. It alarmed my daughter and  911 was called. A stroke was ruled out by paramedics and I was then transported to the ER for further assessment. I was admitted for further testing and observation because I kept going in and out of a fugue state.
Pt received Moderna  covid-19 vaccine Booster at 11:11, c/o flushing and mild sob 14mins after vaccine administration. Pt was asssisted to gurney and was placed on his back with hob raised to 30 degrees. V/s taken per protocol. Benadryl 50mg tabs were administered. Allergist Dr. was notified, instructed to keep for an additional 30min. Pt left facility at 11:58am, denies any allergies symptoms. Instructed patient to call 9-11 or go to ER if symptoms  worsen later during the day.
sore arm, headache, extreme bodyaches,  joint aches, fever (100.5 degrees - normal 97.4 degrees) after 2 excedrins.  shivering, nausea, hives from  left shoulder to elbow. Most symptoms last 2 days, but the hives have last 10 days. (slowly improving)
Developed rash, weakness, dizziness, mild chest pain, nausea, temp approx 100 degree * 1 week.