chrisvoncsefalvay/vaers-outcomes huggingface dataset:
while administering FLUZONE HIGH DOSE vaccine there was a needle issue and patient may have received a partial dose/No AE; while administering FLUZONE HIGH DOSE vaccine there was a needle issue and patient may have received a partial dose/No AE; Initial information was received on 09-Sep-2020 regarding an unsolicited valid non-serious case from a pharmacist .  This case involves a patient with unknown demographics who may have received a partial dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] because there was a needle issue (batch number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  Medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  It was a case of vaccine underdose and needle issue (latency same day).  They were administering the FLUZONE HIGH DOSE vaccination and there was a needle issue and the patient may have received a partial dose.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
cardiomegaly,  with significant bilateral lung abnormality. in addition, pulmonary edema with extensive bilateral multifocal pneumonia
2nd dose was delayed beyond 36 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose was delayed beyond 36 days) 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 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose was delayed beyond 36 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose was delayed beyond 36 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment information was reported.
Dull headache within hour of shot, centered at top, center of head.  Also experienced joint pain later in the day and through next dat (2/12) in ankles, arms and wrists,
Eczema; rash; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), administration date: Feb2021, for Covid-19 immunization. The following information was reported: ECZEMA (non-serious), outcome "unknown", described as "Eczema"; RASH (non-serious), outcome "unknown", described as "rash". Therapeutic measures were taken as a result of eczema, rash.  Additional information: She mentioned that she already got the Pfizer COVID Vaccine, the first dose and the second dose and she has a schedule for the booster shot but the caller is actually having a medicine or a maintenance that is actually a Prednisone treatment. So she is asking if there will be an obstacle to proceed with her third dose of Pfizer booster vaccine. She had a scheduled for a booster dose."Consumer stated, "I had both of my Pfizer shots in February and March and I am due to get my booster, Saturday however, I started on Prednisone (treatment) 4 to 5 days ago for Eczema because I have a terrible rash from Eczema. Dose of Prednisone: 10mg. Indication: Consumer stated, "I have Eczema and I have a terrible rash from it (Further clarification was unknown if consumer had Eczema and terrible rash from the first and second COVID-19 Vaccine) and we are trying to get it under control. My concern is should I continue to get booster shot this Saturday or wait until I am finished with the steroids?". The lot number for the vaccine, BNT162B2, were not provided and will be requested during follow up. She said that she did not have an issue with Pfizer. Her question was whether she could receive the booster while taking steroids. She never got an answer - spoke to my physician who said it was not a problem. On 16Oct2021 I got the booster and had no side-effects.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
My daughter developed an extremely high fever greater than 103 and the next day once the fever broke she developed a rapidly spreading rash that looks very similar in nature to Gianotti Grosti Syndrome.
Rash was reported as worsened.; she has developed a rash all over her face, arm, chest, and belly; The rash is just red, raised, and itchy; The rash is just red, raised, and itchy; This is a spontaneous report from a contactable Nurse (patient). The 61-years-old female patient received first dose of bnt162b2 (BNT162B2, lot number: EL3248, Expiry Date: 01Apr2021), unknown in right deltoid on 13Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included Patient History: No. No allergies. There were no concomitant medications. The Caller, an LPN, reporting on the COVID 19 Vaccine and who explains she had it on 13Jan2021. Starting Friday into the weekend and through today she has developed a rash all over her face, arm, chest, and belly on 18Jan2021. The only thing that she can figure is the injection. She was told to call and report this.  There has been no treatment, due to the holiday everything is closed. The rash is just red, raised, and itchy and driving her crazy. It is not anything too terrible, just uncomfortable. Rash was reported as worsened. No visit to emergency room or physician office. The outcome of the event condition aggravated was unknown and was not recovered or the rest events.  No follow-up attempts possible. No further information expected.
This case was reported by a consumer (also the subject) and described the occurrence of fatigue in a 37-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline. A physician or other health care professional has not verified this report. Relevant medical history included acid reflux and Epstein Barr virus. Concurrent medications included Prevacid. On 11 June 2011 at 16:00 the subject received a dose of BOOSTRIX (.5 ml, unknown route, right arm). On 12 June 2011, 8 to 10 hours after vaccination with BOOSTRIX (after midnight), the subject experienced "extreme" fatigue, body pain, chills and diarrhea. At the time of reporting the event of fatigue was unresolved, and the events of body pain, chills and diarrhea were resolved on 14 June 2011.
Per Employee's Incident report:  Five minutes later, while I was in the elevator, I started to experience burning sensation in my abdomen along with SOB, chest pain and tightness, unable to breath properly, nausea and dizziness. Episode lasted about 10 minutes with a very slight relief enough to walk back to my desk. However, once I reached my desk in the clinic, the chest tightness and SOB worsened and I also started to experience stiffness in my neck that radiated to my lower back, I was unable to move my neck due to the stiffness. I immediately notified my manager and was instructed to go to ED.
Had severe vertigo at 4:30 am on 01/31/2018., the next morning. Had trouble with coordination and leg weakness that day. Low back pain and arm pain and shoulder pain started the next day. I have had buzzing in head also. The shoulder pain and weakness has not subsided and the weakness in legs is ongoing. My toes have gotten more numb since the vaccine was administered.. I went to my family dr to report my symptoms from the flu vaccine. As of today two weeks and one day later I still have shoulder and arm pain. Shoulder pain is worse and leg weakness and aching in legs. My numbness in toes continues. And the buzzing in head continues. I drink lots of water and eat healthy hoping this will help but not as of yet.
I called store asking the pharmacist if they have flu shot in vial not the prefilled syringe. The pharmacist assured me that the prefilled flu vaccines they have are latex free. So I went to get the vaccine because it is required by my job. The pharmacist gave me the vaccine. In less than 3 hours later my arm starts swollen and becomes painful. My neck starts hurting too.
Back pain; Decreased appetite; chills; fever; Myalgia; General discomfort; Feeling hot; Pain; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (General discomfort), FEELING HOT (Feeling hot), PAIN (Pain), BACK PAIN (Back pain) and DECREASED APPETITE (Decreased appetite) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Sep-2021, the patient experienced DISCOMFORT (General discomfort), FEELING HOT (Feeling hot), PAIN (Pain), DECREASED APPETITE (Decreased appetite), CHILLS (chills), PYREXIA (fever) and MYALGIA (Myalgia). On 07-Sep-2021, the patient experienced BACK PAIN (Back pain). On 07-Sep-2021, CHILLS (chills) and PYREXIA (fever) had resolved. On 08-Sep-2021, MYALGIA (Myalgia) had resolved. At the time of the report, DISCOMFORT (General discomfort), FEELING HOT (Feeling hot), PAIN (Pain), BACK PAIN (Back pain) and DECREASED APPETITE (Decreased appetite) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication use was reported.   This case was linked to MOD-2021-313117 (Patient Link).
vial was shaken before and was injected half way down elbow/arm; she recieved a rash around the injection site; vial was shaken before and was injected half way down elbow/arm; vial was shaken before and was injected half way down elbow/arm; This is a spontaneous report from a contactable consumer (patient herself) via a Pfizer-sponsored program .   A female patient of an unspecified age received bnt162b2 (Pfizer BioNTech COVID-19 Vaccine, Formulation: Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in arm on Jan2021 as dose 2, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1, an unspecified date for covid-19 immunization Caller stated worried about way second dose of    vaccine was administered 17 days ago (Jan2021); vial was shaken before and was injected half way down elbow/arm, caller stated 2-3 days (Feb2021) later she received a rash around the injection site. The outcome of events was unknown.  Information on the lot/batch number has been requested.
This case was reported by a nurse via call center representative and described the occurrence of influenza-like symptoms in a patient who received BEXSERO for prophylaxis. Previously administered products included BEXSERO (1st dose received a year before the reporting date). On an unknown date, the patient received the 2nd dose of BEXSERO. On an unknown date, unknown after receiving BEXSERO, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown. Additional details were provided as follows: No patient identifiers were provided. The age at vaccination was not applicable for this report. The healthcare professional (HCP) reported that the patient never received the 2nd dose of BEXSERO, which led to incomplete course of vaccination. No side effects were reported. Follow up information received from a nurse on 6th July 2018: The reporting nurse had received acknowledgement letter and would like to provide additional information but wanted confirmation of who the patient was.  Without a date of birth or other patient identifier, the nurse was unable to provide further details and was wondering if perhaps the patient was the reporter. The nurse did not provide the patient's name and was unable to locate original report. Co-suspect products included HPV 16-18 (HPV vaccine) for prophylaxis and BEXSERO for prophylaxis. The nurse believed it was the patient who experienced flu-like symptoms after having BEXSERO and HPV vaccine on same day, a couple weeks before the date of reporting. On an unknown date, the outcome of the influenza-like symptoms was unknown. It was unknown if the reporter considered the influenza-like symptoms to be related to BEXSERO and HPV vaccine.
Initially had localized redness, quarter to a half dollar sized swelling, on 3/10/2021. Patient received an iron infusion at 15:00 on 3/10/2021. Around 2:00 on 3/11/2021, patient felt a chill, her temperature was 100.4 F orally. Temperature further increased to 103 F around 13:00 on 3/12/2021.   What happened as a result of the adverse event? (doctor visit, ED or urgent care visit, hospitalization, life threatening illness, disability/permanent damage, death, none of these): none of these, took OTC apap last night and this morning and just took ibuprofen after the 103 F reading.  Spoke with patient's mother, who stated that the is feeling fine. The patient's temperature is currently 98.6 degrees Fahrenheit, and initially came back to normal at 02:00 today (3/13/21). The patient experienced elevated temperatures before that time (02:00), of note was at 22:00 on 3/12/21, at which time the patient had a temperature of 102 degrees Fahrenheit. A later temperature after 22:00 on 3/12/21, and before 02:00 on 3/13/21, was recorded, which was 101 degrees Fahrenheit.   The patient's mother stated that the daughter may have COVID based upon speaking with her doctor, so she inquired if her daughter should be tested for the presence of antibodies against COVID-19. Patient's mother also inquired if there was a need for the second shot if it was seen that her daughter had antibodies against the virus.  Advised the mother that her questions would be looked into for answers, and that she would be called back with those answers.
This spontaneous report was received from a clinical supervisor who was a medical assistant, regarding to multiple (unspecified number) patients. Patient demographics were not reported. Information on concurrent conditions, medical history and drug allergies of the patients were not reported. Illnesses of the patients/siblings at the time of/prior to vaccination were not reported. On an unknown date in January 2016 (at unspecified times between 09-JAN-2016 and 15-JAN-2016) the patient was vaccinated with ROTATEQ (lot # L020861, expiry date 25-JAN-2017), (lot # L008057, expiry date 01-DEC-2016) (dose number, dosage units, route and anatomical location not specified). Concomitant medication were not reported. On an unknown date in January 2016 (at unspecified times between 09-JAN-2016 and 15-JAN-2016), the reporter stated that unspecified number of patients received unspecified doses of ROTATEQ that were improperly stored. Temperature at which the vaccines were maintained was reported to be 54.1 (units not provided), time frame was 3.5 hours, no previous temperature excursions were performed. No adverse effects were reported. Additional information has been requested.
I received the vaccine when 39 weeks and 1 day pregnant (due date was 2/4/21).  I had very mild contractions earlier in the day, prior to receiving my vaccine, but these just seemed to be Braxton-Hicks.  My water broke about 4 hours after getting the vaccine.  I then had a placental abruption and needed an emergency cesarean.  Symptoms during delivery included reduced fetal heart rate and I had bleeding.  My baby was born with birth weight of 7#, 0.9 oz.  She was healthy with no medical complications.  The surgeon reported there was blood in my uterus when they delivered her.
Chills start about 18 hours after injection . Fever over 102 started about 24 hours. 1 round of ibuprofen taken, with in an hour or so, temp dropped to around 100. Sometime in the night fever went away. Awoke next day, no fever, discombobulated, but feeling perfectly fine.
Five minutes after injection I broke into extreme sweating, hot flash, nausea, fatigue and head ache. I was at work and requested to go home early. I fell asleep one hour into my arrival and slept for 17 hours. Up to and including today I am having headaches, pain in my legs on left side only, nausea, lack of sleep and a continued smell similar to dried blood after a injury. I have also have and continue to have shortness of breath and chest pains resulting in two panic attacks within the last three days. This has led me to report this and I have doctor visit scheduled for 4/22. I also reported today based on internet search of reactions.
pt is 11 years old Pt accidently received adult( ages 12 - adult ) bivalent covid pfizer vaccine. doctor/ supervisor informed
It's sore; REDNESS; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (It's sore) and ERYTHEMA (REDNESS) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (It's sore) and ERYTHEMA (REDNESS). At the time of the report, PAIN (It's sore) and ERYTHEMA (REDNESS) outcome was unknown.            Concomitant medications were not provided. Treatment information was not provided.
Patient received a dose of Infanrix that had expired; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 18-month-old female patient who received DTPa (Infanrix) (batch number 49TM3, expiry date 28th May 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 31st May 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 31st May 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, 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: 31-MAY-2022 Reporter's comment: The nurse reported that the patient received a dose of Infanrix that had expired. The reporter consented to follow up. The Vaccine Administration Facility is the same as Primary Reporter. Additional Supportive Information: The patient received Infanrix which was already expired, which led to expired vaccine used.
Local rx to varicella open vesicle Left thigh at documented injection site no induration and no erythema.
SOMETIMES SHORT OF BREATH; DIARRHEA; DIZZY; HEADACHE; TIRED; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 to left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 13-MAR-2021, the subject experienced dizzy. On 13-MAR-2021, the subject experienced headache. On 13-MAR-2021, the subject experienced tired. On 14-MAR-2021, the subject experienced diarrhea. On an unspecified date, the subject experienced sometimes short of breath. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the diarrhea, dizzy, headache, tired and sometimes short of breath was not reported. This report was non-serious.
The pt returned to clinic for PPD reading on 05/16/2002. Mother states right arm is swollen for a day, temp 98.3 deg F. Right upper arm diffusely edematous, warm, red, 4cm larger than left. Right axillary lymphadenopathy. Treated with Augmentin.
PATIENT RECEIVED TDAP, MCV4 AND HPV VACCINE TODAY. AFTER GIVING THE LAST VACCINE WHICH WAS HPV AT 11:16 AM PATIENT PASSED OUT. SHE WAS STILL SEATED IN CHAIR AT TIME. I CAUGHT PATIENT WHEN SHE WAS STARTING TO LEAN OVER AND LAID HER BACK ON MY LAP. WE APPLIED COOL DAMP CLOTHES TO HER FACE AND NECK. SHE CAME BACK AROUND WITHIN THE NEX MINUTE. WE SAT HER BACK UP IN CHAIR AND SHE WENT OUT AGAIN. WE THEN MOVED HER ONTO THE EXAM TABLE TO LIE DOWN. AFTER SHE CAME BACK AROUND WITHIN THE NEXT MINUTE SHE DENIED ANY NAUSEA. SHE SAID HER HEAD HURT A LITTLE BIT. O2 SAT WAS 99% HER BP WAS 119/57 AND PULSE WAS 88. BP REPEATED AND WAS 110/59. STATED SHE WANTED TO TRY AND SIT UP. AT 11:33 WE SAT HER UP AND SHE DRANK SOME WATER. AT 11:34 HER BP WAS 108/67 AND PULSE 93. AT 11:39 HER BP WAS 101/53 AND PULSE 82. SHE SAID SHE WANTED TO LAY BACK AGAIN. I RECHECKED HER BP AT 1145 AND IT WAS 102/56 AND PULSE 82. AT 1154 SHE SAT UP ON EDGE OF EXAM TABLE AND SAID "SHE FEELS BETTER" COLOR WAS GOOD AT THIS TIME ALSO. AT THIS TIME WE HAD HER TO STAND UP AND SHE SAID SHE FELT FINE. HAD HER TAKE A FEW STEPS AND SHE SAID SHE WAS FINE. HER GAIT WAS GOOD. AT 11:58 SHE SAID SHE "FEELS BETTER" AND WALKED OUT OF CLINIC WITH HER MOTHER.
Severe swelling at injection site with skin turning purple. Loss of sensation of arm below injection site. headache. Injection site painful to touch.
Information has been received from a pharm D. concerning a 29-year-old female who on 12-SEP-2007 was vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). The pharmacist was not certain if the patient received measles virus vaccine live (MSD) or measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn (+) rubella virus vaccine live (Wistar RA 27/3). On an unspecified date the patient developed measles. The patient sought medical attention via the emergency room. At the time of the report the patient status was not recovered. A product quality complaint was not involved. Additional information has been request.