chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a certified medical assistant and a healthcare worker, concerning a 63 year old female patient who in October 2003, was vaccinated with PNEUMOVAX.  The certified medical assistant reported that on 15-OCT-2008, the patient was vaccinated with a second dose of PNEUMOVAX (lot #661528/0867X).  On 16-OCT-2008 the patient experienced injection site reaction with redness and had pain in her arm.  On 17-OCT-2008, the patient was seen by the doctor and her reaction was getting better but still red.  This is one of several reports, received from the same source.  Additional information has been requested.
KAWASAKI'S DISEASE; PYREXIA; A spontaneous report has been received from the regulatory authority concerning a patient of unknown gender (age not provided) of Unknown ethnic origin.    No medical history was reported. The following demography was reported for the patient's parent:   Sex: Unknown    No concomitant products were reported.    On an unknown date the patient received Influenza Vaccines (influenza vaccines), via nasal route, for prophylaxis.     On an unknown date the patient started treatment with Pneumococcal Vaccine 13v (pneumococcal vaccine 13v) for prophylaxis.     An unknown administered INFLUENZA VACCINES. No malfunction has been reported for this combination product.    On an unknown date, the patient experienced kawasaki's disease (preferred term: Kawasaki's disease). On an unknown date, the patient experienced pyrexia (preferred term: Pyrexia).     It was unknown if any action was taken with Influenza Vaccines and Pneumococcal Vaccine 13v.    The outcome of the events of kawasaki's disease and pyrexia was unknown.     The reporter assessed the event of kawasaki's disease and pyrexia to be serious due to seriousness criteria of hospitalization and important medical event.     For regulatory reporting purposes, if an event is spontaneously reported, at least a reasonable possibility of a causal relationship is implied by the reporter, even if the relationship is unknown or unstated.    Device Information:     Combination Product Report: Yes    Product As Reported: INFLUENZA VACCINES  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect    Minor correction on 31-May-2023: Hospitalization required selected for events kawasaki's disease and pyrexia. Narrative amended.    Minor correction on 01-Jun-2023: Minor correction on 01-Jun-2023: Treatment Facility (checking in association with Reporter User Facility) was linked to each individual Serious/Hospitalization event. Nullflavours added for event dates. Narrative amended.; Sender's Comments: Kawasaki's disease and pyrexia are not listed in the company core data sheet of Q/LAIV(Quadrivalent/ live attenuated influenza vaccine). Kawasaki's disease could be considered as contributory risk factor for pyrexia. Due to limited information on circumstances leading to events, start date of suspect drug, complete patient demographics, onset date and outcome of events, clinical course, treatment provided, risk factors, relevant medical history, concurrent conditions, concomitant medications, detailed diagnostic and etiologic workup, the evaluation did not find the evidence to suggest a causal relationship between the events and suspect drug.
Information has been received from a pharmacist concerning a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapy were not provided. On unspecified date (reported as "when he was 6 months of age, 6 years old and 12 years old"), and on an unspecified date in July 2016, the patient was vaccinated with the first, second, third and fourth doses of M-M-R II (lot number, expiration date, strength, dose, frequency and route unknown) (drug use for unapproved schedule and unapproved dose administered). The pharmacist did not know why the patient received so many doses of M-M-R II and stated that the patient now wanted to receive another dose. No adverse events were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
patient felt like her arm and face were being poked by pins and needles in the vaccinated arm lips and side of the face, it gradually went away as hours passed
Two days after receiving the second shot, I developed hives across my torso, legs, and arms and have experienced muscle stiffness. I am not prone to hives. Periodic lightheadness has also occurred.
2nd in Hep B series given; c/o intense pain feels like someone kicked in the arm @ inject site cont x 2 hrs; approx 10 mins later had epiosde of chest pain, dizziness; uvula became swollen & stayed for approx 2 hrs; no redness or swellin;
Patient reported feeling nauseated the morning 4/13/22; vaccine administered 4/13/22 at 1539. Patient was up several times throughout noc to bathroom. Last observed well at 0530 on 4/14/22.  Patient was noted deceased just prior to 0800 on 4/14/22 when CNA went to wake for bath. No signs of localized reaction from injection.
None. Pt received PEDIARIX and Hep B (single dose) on 11-5-08.
Pain, unable to lift left arm as of 1 week, unable to sleep without pain. Decreased range of motion and strength.
It was reported that a 52 year old female patient received a Fluzone SV vaccination on 11/15/2000. Reportedly 3-4 hours after the injection the patient developed a feeling in her throat (type of feeling not specified) and difficulty swallowing. There was no respiratory distress. These symptoms completely subsided in 12 hours.
Body aches; fatigue; and then woke up the next day, in the morning with mild headache - muscle and joint pain/aches; headache; next day still had all of that. 3rd day - everything was slowly improving but still body aches muscles aches fatigue - that continued for about a week and that went away.   Recurrence on 10th day for one day. Jan 23 - 2nd dose of vaccine.
sensation on top of head like it's wet; headache, which has not subsided; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (sensation on top of head like it's wet) and HEADACHE (headache, which has not subsided) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: J&J COVID-19 Vaccine (First dose (Batch Number: 043A21A)) on 08-Apr-2021. Past adverse reactions to the above products included No adverse event with J&J COVID-19 Vaccine. Concurrent medical conditions included Blood pressure. Concomitant products included METFORMIN and ROSUVASTATIN for an unknown indication.    On 09-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (headache, which has not subsided). On 12-Dec-2021, the patient experienced HEAD DISCOMFORT (sensation on top of head like it's wet). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, HEAD DISCOMFORT (sensation on top of head like it's wet) outcome was unknown and HEADACHE (headache, which has not subsided) had not resolved.            Concomitant medication of the patient also included blood pressure medication at a frequency of once a day.  The booster dose was injected in the left nondominant arm.
Red below injection site ,swelling with second day getting a rash, not raised  went away and then reappeared.  Went away after two days of tyneol
I woke up and there was swelling in my left axilla the size of a large lemon. The area around my left shoulder/axilla (site of COVID booster) is tender and painful. My left hand is tingly and colder than my right. The swelling and pain has continued to today.
arm swelling; This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced swelling arm. On an unknown date, the outcome of the swelling arm was unknown.   It was unknown if the reporter considered the swelling arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccine was not reported. The patient experienced arm swelling. The reporter did not consent to follow up.
24 Hours after - 101.5 fever, chills, lasting 36 hours  on 2/27 I broke out all over my face and neck.  Red pin prick marks that itched and were swollen.  Went to urgent care - 40 mg of prednisone provided for 2 days, along with benedryl & zyrtec.
Seen in office on 5/2/01 at 15:00 with left upper arm at site of DTAP with 7cm X 6.5cm raised, red and warm area. No cellulitis. Discharged home with instructions to treat with Benadryl and cook packs.
The patient & father stated patient's age was 12 with a DOB 1/19/2009. After administering the shot, upon billing the insurance, it was discovered the patient's DOB on file is 11/19/2009, therefore the patient is not yet 12 years old for whom the vaccine is indicated for.
My 8 yr old had an allergic reaction while in the observation area; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the parent.  An 8-year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 1 (tris), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: ANAPHYLACTIC REACTION (medically significant) with onset 2021, outcome "unknown", described as "My 8 yr old had an allergic reaction while in the observation area". The event "my 8 yr old had an allergic reaction while in the observation area" was evaluated at the emergency room visit.Clinical course:  ''Both my 6 yr & 8 yr old daughters received their 1st covid vaccine. My 8 yr old had an allergic reaction while in the observation area, they sent her by ambulance to ER, we just received an email from withheld (our insurance) that we owe $2000.00. Wouldn't think be covered since she got the vaccine as suggested and has no history or ever reacting to medications, vaccines or anything...our insurance says we must pay, we believe in vaccines and find this unsettling.''  The lot number for bnt162b2 was not provided and will be requested during follow up.
Persistent seizures. 14 with multiple anti-convulsants. See by 2 neurologists.   Nurse follow up on 07/20/04 states: "fever, viral illness."  Per annual report-continues to require anti epileptic drugs to control seizure activity.
Within 15 minutes of injection at 11:30 a.m. my face and neck turned bright red. Chills began immediately after and lasted until 2 a.m. Nausea began shortly after chills. Vomiting at 2 a.m.  Fever as high as 101.6. Took Tylenol at 5 a.m. and fever came down. Aching in joints.  Felt like someone hitting knees with hammer.  Wrists too painful to move.  Jaws were throbbing. Lower right lip and chin numb until  9 or 10 a.m. the next day. Itchy Rash on fingers, feet and neck.  Small raised spots that would remind you of poison ivy.
w/in few hrs p/vax had sz constant screaming for several hrs 2 hrs p/vax, inject site swollen; seen by MD; MD advised no further pertussis shots-t100 R;
Symptoms from the Pfizer vaccine has been numb like feeling in the face, arms, legs, and hands. These symtoms arised Saturday Jan. 23, 2021 (a day after vaccine). Within the next couple of days, symtoms were still present, and presented more frequently throughout the days. Occuring more than 4 times a day.
had the flu; Initial information was received on 29-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer.  This case involves patient (unknown demography) who had the flu (influenza), while the patient received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious had the flu (influenza) (about 2 weeks) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome of the event was unknown.  There will be no information available on the batch number for this case.
Patient fainted approximately 5-7 minutes after receiving her vaccine. Patient was breathing rapidly, had tingling in fingers, felt warm, blurred vision
10/29/21 patient presents to EC ED with c/o cough and fatigue, tested positive for COVID 3 days prior to admission.
Patient received vaccines, and after receiving vaccine she began to experience palpations every 15-20 minutes. Patient denied any other symptoms and had no pain or discomfort.
Information has been received from a female patient of unknown age referring to herself. Medical history and drug allergy were not reported. On an unknown date the patient was vaccinated with (Oka/Merck) VARIVAX (dose, strength, route, lot # and expire date were not reported) when she was pregnant. Concomitant drug was not reported. The Last Menstrual Period (LMP) and Estimated Date of Delivery (EDD) were not reported. It was not reported whether the patient sought medical attention. At the time of reporting, the outcome of pregnancy was pending. Additional information is not expected because the reporter declined to participate in answering questions and no contact information was provided.
Vaccine had already expired on 01/17/2020 and the Medical Assistant that gave the vaccine did not realize it before she administered it on 01/27/2020. No reaction reported by patient's mother, but Dr. wanted it reported since an expired vaccine was given.
SHAKING; PAIN ACROSS UPPER BACK WHOLE BACK; PAIN BEHIND THE NECK; CHILLS; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 08-MAR-2021 10:00 AM for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021 15:00 pm, the patient experienced shaking. On 08-MAR-2021 15:00 pm, the patient experienced pain across upper back whole back. On 08-MAR-2021 15:00 pm, the subject experienced pain behind the neck. On 08-MAR-2021 15:00 pm, the patient experienced chills. On 08-MAR-2021 15:00 pm, the patient experienced nausea. On 08-MAR-2021 15:00 pm, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, headache, pain across upper back whole back, pain behind the neck, nausea and shaking was not reported. This report was non-serious.
was sent to the hospital due to a stroke; This is a spontaneous report from a contactable consumer (patient's wife) reported that a 63-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration on 27Mar2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced stroke and was sent to the hospital. The patient was not able to get the second dose tomorrow (as reported). His 2nd dose will be on 17Apr2021. Outcome of event was unknown.  Information about lot/batch has been requested.
From time of injection, I had a bump at the vaccination site.  This was not present before the vaccination.  There was nothing visibly wrong with the skin on my arm prior to the vaccination.  My arm was sore for a day or so which is normal.  The bump never went away, so I figured I was going to have a scar.  Then after a couple of month or so, I noticed that the bump was changing over time.  Sometimes it would be red, sometimes brown, and the texture was changing.  I went to the dermatologist who did a biopsy.  The biopsy came back positive for basal cell carcinoma.  It is infiltrated (deep) so I must have skin surgery to remove it.  Surgery is scheduled.
Arm soreness at injection site; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer.), for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Arm soreness at injection site"; HEADACHE (non-serious), outcome "unknown". Additional information: Arm soreness at injection site, headache after receiving Pfizer BioNTech bivalent original and omicron ba.4/ba.5 vaccine and flu shot. Events took place after use of product.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
pt had a positive COVID test on 6/29/22;7/2/22 to ED with abnormal lab results and terminal respiratory secretions; given Scopolamine patch and Robinul; pt has fever and cough; family desires comfort measures (pt in end-stage Alzheimer's); 7/12/22 pt dc'd to Hospice where she passed away 3 days later
patient received 2 doses of DTaP-IPV from the PENTACEL vaccine with no reported adverse event; it was not reconstituted with the powder HIB portion with no reported adverse event; Initial information received on 24-Oct-2023 regarding an unsolicited valid  non-serious case received via Nurse.  This case involves a 4 years old female patient received 2 doses of dtap-ipv from the diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] vaccine with no reported adverse event and it was not reconstituted with the powder hib portion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) nd family history were not provided.  On 24-Oct-2023, the patient received a dose 1 of 0.5 ml dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection (strength: unknown) (lot: UJ870AA, expiry date: 24-Mar-2024) via intramuscular route in the left deltoid for immunization and patient received 2 doses of dtap-ipv from the pentacel vaccine with no reported adverse event (extra dose administered) and it was not reconstituted with the powder hib portion with no reported adverse event (poor quality product administered) (latency: same day)      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 and Regulatory Authority 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.
Experienced tension headache so severe that vision was blurred and muscles in neck tensed up. To the point where tizanidine and sumatriptan did not help. Felt extremely nauseous and intense pressure in head. Blood pressure dropped and was very sweaty. Had to be transported to ER via ambulance. Vomiting occurred for several hours. Was given Tylenol, Benadryl, zofran, imotrex, Valium, and fluids via IV. Sympoms continued for 8 hrs. 12 days later symptoms are still ongoing.
nausea and vomiting, 12 hrs after,  headache, dizziness
C-reactive protein result high/C-REACTIVE PROTEIN WAS HIGH; Vaccination site pain/ ARM PAIN CAUSED BY COVID VACCINES AND BOOSTER; Joint pain; Headache/ HEADACHE CAUSED BY COVID VACCINES AND BOOSTER; This spontaneous case was reported by a consumer and describes the occurrence of C-REACTIVE PROTEIN INCREASED (C-reactive protein result high/C-REACTIVE PROTEIN WAS HIGH), VACCINATION SITE PAIN (Vaccination site pain/ ARM PAIN CAUSED BY COVID VACCINES AND BOOSTER), ARTHRALGIA (Joint pain) and HEADACHE (Headache/ HEADACHE CAUSED BY COVID VACCINES AND BOOSTER) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis. Concomitant products included METHOTREXATE and HYDROXYCHLOROQUINE for an unknown indication.   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced C-REACTIVE PROTEIN INCREASED (C-reactive protein result high/C-REACTIVE PROTEIN WAS HIGH), VACCINATION SITE PAIN (Vaccination site pain/ ARM PAIN CAUSED BY COVID VACCINES AND BOOSTER), ARTHRALGIA (Joint pain) and HEADACHE (Headache/ HEADACHE CAUSED BY COVID VACCINES AND BOOSTER). At the time of the report, C-REACTIVE PROTEIN INCREASED (C-reactive protein result high/C-REACTIVE PROTEIN WAS HIGH) and ARTHRALGIA (Joint pain) had not resolved and VACCINATION SITE PAIN (Vaccination site pain/ ARM PAIN CAUSED BY COVID VACCINES AND BOOSTER) and HEADACHE (Headache/ HEADACHE CAUSED BY COVID VACCINES AND BOOSTER) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, C-reactive protein: High.         This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No information regarding treatment medication was provided.
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received BNT162b2 (BNT162B2), on 17Feb2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto" (unspecified if ongoing); "thyroid" (unspecified if ongoing); "Hypogonadism" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 13Jun2022, outcome "unknown", COVID-19 (medically significant) with onset 13Jun2022, outcome "recovering" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient tested positive and felt sick on 13Jun.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.