chrisvoncsefalvay/vaers-outcomes huggingface dataset:
husband now has a lump that is pretty good in size at the injection site.; This is a spontaneous report from a contactable consumer. This consumer reported for her husband. A 58-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 17Mar2021 (Batch/Lot number was not reported), at vaccination age of 58 years,  as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced a lump that is pretty good in size at the injection site (non-serious) on Mar2021 with outcome of unknown. No follow-up attempts are possible. Information about Lot/batch number cannot be obtained.
This spontaneous report was received from a medical assistant referring to a 4 year old male patient with Kawasaki's disease. The patient's drug reactions/allergies and concomitant medication were not reported. On 22-NOV-2017, the patient was vaccinated in the left arm with an improperly stored dose of PROQUAD, lot number: N008825 (expiration date: 12-SEP-2018), dose 1, intramuscularly, for prophylaxis (strength and dosage schedule were not provided). There was digital data logger involved. The storage characteristics were the following: - Temperature: -9.4C for 10 hours - Previous temperature excursion: -8.9C for 8 hours and 51 minutes. No adverse effects were reported.
Briefly, patient is a 58-year-old female with history of poorly controlled type 2 diabetes mellitus with A1c of 12.6, hypertension, GERD, LVH, hyperlipidemia, cognitive impairment?, who presents to the emergency department with her sister with worsening cough over the past week.  She is also experienced associated poor p.o. Intake and lethargy and has not been compliant with her insulin because of decreased p.o. Intake.  Patient was found to have COVID with evidence of bilateral COVID pneumonia on chest x-ray.  Is currently on 2 L nasal cannula oxygen as she desatted to 86% with ambulation on room air.  She has been started appropriately on remdesivir, Decadron.  Okay for antibiotics for now the likely will discontinue if pro count negative x2.  Wean oxygen as tolerated to maintain sats greater than 90% on room air.  Monitor renal function, avoid IV fluids.  Promote p.o. Intake.  Supportive cares.  Aggressive ISS.  Aggressive dm 2 control with initiation of steroids.
Small amount of daily, intermittent sinus drainiage since receiving the Flu Mist.
itchy around the injection site; red circle around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itchy around the injection site) and VACCINATION SITE ERYTHEMA (red circle around the injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (itchy around the injection site) and VACCINATION SITE ERYTHEMA (red circle around the injection site). At the time of the report, VACCINATION SITE PRURITUS (itchy around the injection site) and VACCINATION SITE ERYTHEMA (red circle around the injection site) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: No specific follow-up information recorded.
whole body rash with welts, itching; whole body rash with welts, itching; whole body rash with welts, itching; This is a spontaneous report received from a contactable consumer (patient) reported for himself.   A 26-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: ER8733) via unknown route of administration at left arm on 01Apr2021 at 13:15 (age at vaccination 26-year-old) as dose 1, single for COVID-19 immunisation at public health clinic/veterans administration facility. The patient had no other allergies. The patient medical history included asthma from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient Concomitant medication (other medications) included Allegra for unknown indication within 2 weeks of vaccination. Prior to vaccination, was the patient was diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19. After 3 days, the patient experienced whole body rash with welts and itching on 04Apr2021 at 17:30. The adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient had received treatment for the events. The outcome of the events was recovering.  No follow-up attempts are needed. No further information is expected.
Patient reported swelling, redness, warmth and slight itching in area where vaccine was administered. This was observed when she came in to pharmacy the next day and was instructed to go visit urgent care.
ADMINISTRATION ERROR; This spontaneous report received from a pharmacist concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced administration error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration error was not reported. This report was non-serious.
Fever, headache, body aches, fatigue, elevated blood pressure, elevated heart rate, PVCs present, and Pulsatile Tinnitus faster and louder
PATIENT RECEIVED PFIZER BOOSTER LESS THAN 6 MONTHS FROM THE 2ND DOSE-PATIENT HAD THE 2ND DOSE ON 7/19/2021.  PATIENT ATTESTED THAT IT HAS BEEN 6 MONTHS BUT SAID  SHE MISCALCULATED THE TIME. SHE WAS STABLE AND DID NOT HAVE ANY ADVERSE REACTION. SHE LEFT IN STABLE CONDITION.
Headache. Very sore right arm. Pain in back. Pain achy in fingers all right side down to toes
the patient is 3 years old but was given Pfizer Covid vaccine for the age (5-11y), this mistake was done because of the information that was filled online in the consent form by his parents . the consent form had the age 5 and the type of vaccination was Pfizer (5-11y) the vaccine went through the insurance without any problems even with the patient's name and DOB  when the mom was asked in the room to confirm the child's date of birth she mentioned year and based on that pt was given the vaccine for 5YO not for 3YO His mother checked with the DR , DR said" it is fine and he will be okay " I called the mother next day 06/25/2022 and asked about patient, she said he is perfectly fine and playing with no problems at all
POSSIBLE CELLULITUS. PATIENT TREATED WITH KEFLEX 500 MG PO ON 02/23/03. UNABLE TO TOLERATE, THEN TREATED WITH DICLOXACILLIN 250 MG #80 AND DIPHENHYDRAMINE 50 MG ON 02/24/03.
got soreness in the arm only after the second one but that went away in a day or two. No redness at site; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (got soreness in the arm only after the second one but that went away in a day or two. No redness at site) in a male patient of an unknown age who received mRNA-1273 (Spikevax) (batch nos. ASKU and ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (got soreness in the arm only after the second one but that went away in a day or two. No redness at site). At the time of the report, VACCINATION SITE PAIN (got soreness in the arm only after the second one but that went away in a day or two. No redness at site) had resolved.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported.  Patient received 4 shots. Original two, booster and bivalent booster, all Moderna. Patient had the Bivalent with no reaction.   Reporter mentioned on the line that they had the Moderna vaccine and got soreness in the arm only after the second one but that went away in a day or two. No redness at site.   No treatment drug was reported.   Reporter did not allow further contact
The shot was administered at a vertical position rather than a horizontal position.  The physician asked me to wait 30minutes after the vaccine.  I did  experience sweats, fever and headaches.  I pre medicated myself with Benadryl 25mg an hour in a half before the injection.  My BP readings were 130/90.  I discussed with my physician i was doing a daily log on my BP. My systolic  BP reading were between the 90-100.  I was prescribed Losartan 25mg. After post 24 hours after the injection it dissipated the next day.
This spontaneous case, initially received on 05-Oct-2016, was reported by a Non-Health Professional and concerns a female patient. Weight: not provided; Height: not provided. Administration of company suspect drug(s): On an unknown date, the patient received H1N1 Influenza Vaccine (INN) for indication not reported. Dose regimen: Not reported, Route of administration: Not reported. Batch number: Not reported. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, the patient experienced a bad reaction of transverse myelitis (medically significant) and since this happened, the patient has also experienced multiple cases of shingles in her ear and inner leg on unspecified dates. Outcome for all events: not reported.; Sender's Comments: Company comments: Listedness:  Brand of vaccine not specified. Assessment according to the CCDS for CSL's H1N1 Influenza Vaccine transverse myelitis and herpes zoster are unlisted. Causality: Unassessable for event transverse myelitis as there was no information relating time of event onset following vaccination, event description, mode of diagnosis, treatment and outcome. Herpes zoster in considered not related to H1N1 Influenza vaccine as it is a viral infection that cannot be transmitted via vaccination.
Swelling and heat located 2-3 inches below injection site on right arm. Instructed patient to put ice on the area and take Benadryl. If no improvement by tommorrow morning, contact physician.
COVID-19; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4375465-00.  A 55-year-old female patient received BNT162b2 (BNT162B2), in Feb2021 as dose 1, single (Batch/Lot number: unknown) and in 2021 as dose 2, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2021) Unknown Results.  Clinical information: In 2021, the patient experienced COVID. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality with Covid-19 vaccine was reported as possible as per the reporter for events of covid-19 and drug ineffective.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information the events Drug ineffective and suspected  Covid-19 assessed as related to the suspect drug BNT162b2.
Seizure- labored breathing, tonic clonic, altered consciousness/ unresponsive- duration 4 min, followed by post-ictal state, transported to hospital
Headache; Nausea; This is a spontaneous report from a contactable consumer. This consumer (patient parent) reported for 12-year-old male patient(son) that he received BNT162B2 (BioNTech Covid-19 Vaccine, formulation: Solution for injection, batch/lot number: unknown), via unknown route of administration on 19Aug2021 (at the age of 12 years old) as a DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medication was not reported. The patient experienced headache and nausea on 19Aug2021. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 03-SEP-2013 the patient who was a hospital employee was inadvertently vaccinated with a 0.5 ml dose of  M-M-R II (lot # 1251AA, expiration 01-AUG-2013), subcutaneously that had expired on 01-AUG-2013. No adverse effects reported. Additional information has been requested.
altered mental status, weakness, increased falls, fever. Sent to Hospital on 1/29/21.
patient started having burning sensation on his face approximately an hour from after receiving the immunizations especially around his eyes. His eyes started getting watery and produced a lot of tear, which the tears started burning his face further and made his face very irritated. He started scratching his face and the tear spread everywhere; further burning his eyes and face. He currently has swollen lips, large brown sports around his eyes, wound next to his eyes and still burning all over his face.
Heaviness on arm; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Heaviness on arm) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (Heaviness on arm). At the time of the report, LIMB DISCOMFORT (Heaviness on arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
This spontaneous report as received from a registered nurse via company representative refers to a 70 year old female patient. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 30-OCT-2017, the patient was vaccinated with PNEUMOVAX 23 one shot (route, dose number, anatomical location, and expiration date were unknown) with lot # N014946 and expiration date 01-FEB-2019 for prophylaxis. The nurse reported that on the same date, the patient experienced pain, swelling, and redness around injection site after administration of PNEUMOVAX 23. At the time of the report, the outcome of Injection site swelling, injection site pain and injection site erythema was unknown. The nurse did not mention the causality assessment between the events of Injection site swelling, injection site pain, injection site erythema and PNEUMOVAX 23.
A patient over 65 years of age received Fluzone Quadrivalent instead of Fluzone Quadrivalent High-dose, no AE; Initial information was received on 21-Sep-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a patient over 65 years of age (exact age and gender unspecified) who received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination on an unknown date instead of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (Wrong product administered).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  It was a case of an actual medication error due to wrong vaccine administered (latency same day).  The reporter did not have any more information on the vaccines given or the patient due to working remotely and not having all the information. There was no more information for this report.  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 lot number.
Information has been received from a registered nurse (R.N.) concerning a 17 year old female with no pertinent medical history, drug reactions or allergies who on 04-AUG-2008 was vaccinated with a dose of GARDASIL (Lot #660389/1968U).  Concomitant therapy included Hep A (unspecified).  On 04-AUG-2008, after receiving GARDASIL, the patient stood up, passed out with eyes open and hit the ground.  She did not breathe for 30 seconds, eyes were dilated and still open and skin was terrible.  The patient looked like a corpse.  The nurse called the patient the next day (05-AUG-2008) and the patient said she was fine.  Unspecified medical attention was sought.  Upon internal review, "did not breathe for 30 seconds" was determined to be an other important medical event.  Additional information has been requested.
Hypertension (140/95; normally 120s/70s), hyperglycemia (155; normally 90s), tachycardia (140s; normally 80s), short of breath, mild chest pain, generalized arthralgia and myalgia, alternating between chills and flushing, headaches and constant neck pain, anxiety, fatigue.
Reddened area on right deltoid 4.1/4" in length - not itchy,  a little warm.
Sore arm, slight headache, body aches, joint and muscle aches  for several hours, fever of 102 starting around 4 pm, down to 100.4 by 9 pm; normal by 7 am on 3/15 with slight headache and joint aches.  Arm swelling, pain increased by 3/15, continued 3/16 with swollen site warm to touch.  By 3/17 swelling reduced and pain reduced but not gone. All other symptoms resolved within 48 hours of starting.
Patient reported sweating/dizziness while scheduling second appointment. Transferred to observation area. Vitals stable, fluids/crackers given. Patient reported feeling much better.
Patient received the YF-Vaccine on 15 Jun 2018 around 1100 with no immediate adverse event. However, later in the day, the patient began to develop a fever and generalized muscle aches, especially of her bilateral ankles. She has had intermittent fevers over the last 3 days but rising as high as 104 by a forehead thermometer at home. Clinic has treated with alternating TYLENOL and Ibuprofen. No other systemic symptoms. No generalized rash or hives. No lip swelling, tongue swelling. Throat tightness, shortness of breath, wheezing or chest pains. Patient currently denies any myalgia. Clinic notes patient more reserved than usual and does not eat or drink as usual but has voided today.
Mother states she took him to hospital for immunisation in the hospital where he started crying through the day and night. The following day at mid day, he went into a coma. She sought help from a nearby clinic where the doctors revealed that he had acute pneumonia. "Watching him breathe as if it was his last was so traumatising that felt like I was losing my baby". After four days of improvement the condition worsened. She took him to hospital where he was put on oxygen for four days after which doctors confirmed that he had a heart problem. He usually turns blue and it is said there' a deficiency of oxygen. The lips are also bluish and transferred to different parts of the body. They were referred to another Hospital after the scans on the heart and was later diagnosed with cyanotic heart disease and need open heart surgery.
No adverse events occurred.  The patient was given a third dose of the COVID-19 (Moderna) vaccine due to discrepancy in paperwork at the facility.
patients daughter states mom got the vaccine too high that caused bone pain. She was seen by MD and was given an antibiotic.
Patient hospitalized 01/21/22 for distended abdomen. Tested positive for COVID19 1/22/22, asymptomatic-no evidence of hypoxemia. No COVID treatment required during hospitalization.
In the evening of March 25 all of a sudden loud ringing started in my right ear and I also felt a little pressure there, like a cotton ball was stuck in it. A month later the pressure is gone but the ringing persists. Not sure if this is related but in April 2020 I had Bell's Palsy on the affected side (right side) but made a recovery.
On 9/10/17 (a.m.) pt. called stating she has an area of redness at injection site on (R) arm, extending from shoulder to mid-upper arm. Pt. was evaluated at clinic, diagnosed w/cellulitis.
Pt recvd vax & exp dizzy & not so well, disoriented & confused about age; sleepy all day & still feels post ictal; sz disorder, grand mal type w/sz focus in the rt temporal region; syncope, h/a; 20JUL92 h/a, vertigo; vision is blurry;
This spontaneous report as received from a physician refers to a female patient of unknown age. The physician reported that on 09-JUN-2014 the patient was vaccinated with a first dose of GARDASIL (dose, route of administration, lot# and expiration date were not provided). On 02-JUL-2014 the patient was vaccinated with a second dose of GARDASIL (dose, route of administration, lot# and expiration date were not provided) and on 02-DEC-2014 the patient was vaccinated with a third dose of GARDASIL (dose, route of administration, lot# and expiration date were not provided). No adverse effects reported. Additional information has been requested.
Chills; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and FATIGUE (fatigue) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 28-Mar-2021, the patient experienced CHILLS (Chills) and FATIGUE (fatigue). At the time of the report, CHILLS (Chills) and FATIGUE (fatigue) outcome was unknown. Not Provided          Treatment medication was not provided. Action taken with mRNA-1273 in response to the event was not applicable.
Information has been received from a healthcare worker referring to multiple unspecified patients of unknown age and gender. Concurrent condition and medical history were unknown. On unknown dates in June 2015 the patients were vaccinated with improperly stored VAQTA (lot # K012457, expiration date 04-JUN-2017, dose and route were unknown). This is one of several reports received from the same reporter. Additional information has been requested.